Michigan Medicine, JDRF commit to raise $14M for new diabetes center

ANN ARBOR – Michigan Medicine has partnered with type 1 diabetes research nonprofit JDRF to establish the new JDRF Center of Excellence at the University of Michigan.

The goal of the center, through U-M’s Elizabeth Weiser Caswell Diabetes Institute, is to accelerate research to cure type 1 diabetes and to improve lives. This includes safer day-to-day management of diabetes and improving health for those living with T1D by understanding metabolism in teenagers, young adults and those living long term with the condition.

The Center of Excellence was made possible by a grant from JDRF of $7.37 million. Both partners aim to raise nearly $14 million, with JDRF’s goal of more than $7 million and Michigan’s Medicine goal of $6.5 million for the new COE.

In addition to researching the human metabolism and driving a cure, the COE will advance the Elizabeth Weiser Caswell Diabetes Institute’s broad expertise in understanding beta cells that create insulin, and will aim to address life-threatening complications from T1D, including psychological effects.

Ann Arbor resident Elizabeth Weiser Caswell and her father, Regent Ron Weiser, have made leadership gifts to kickstart the project.

Read: University of Michigan regent, wife donate $30M for new diabetes institute

Caswell’s husband, Trey, and two of her three sons have T1D. Her personal experience drove her to become a T1D advocate. Currently an executive committee member of the board of directors of JDRF’s Metro Detroit/Southeast Michigan Chapter, Caswell said she is excited for the new collaboration and hopes it will deliver breakthroughs for T1D.

“Michigan Medicine is the ideal partner for JDRF,” Caswell said in a news release. “The Pediatric Endocrinology team at Michigan has been there for our family very step of the way — advising us on daily care, advances in treatment technologies, and opportunities for clinical research. U-M is asking questions that aren’t being asked. I think the science is so exciting and there are so many areas where we’re poised for a breakthrough.”

“This center offers us game-changing possibilities,” Sanjoy Dutta, Ph.D., vice president of reseSanarch at JDRF, said in a news release. “Through it, we will be able to accelerate the depth of work already underway, connect to other critical projects and readily collaborate in ways not previously possible. This center is a partnership of strengths that we know will advance research in meaningful ways, and, we all hope, will deliver cures for T1D.”

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An autoimmune disease, T1D causes a person’s pancreas to stop producing insulin, a hormone that allows people to get energy from food. In people with T1D, their body’s immune system attacks and destroys beta cells in the pancreas that produce insulin.

Scientists are still trying to understand what causes the condition but believe that both environmental triggers and genetic factors are involved. Unlike T2D, the onset of T2D has nothing to do with lifestyle or diet.

There is no cure for the disease and it is not preventable.


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The role of herbal medicine in diabetes treatment.

Opinions of Saturday, 14 November 2020

Columnist: Cephas Kwaku Debrah


The writer is a Teaching Assistant at the Department of Herbal Medicine, KNUSTThe writer is a Teaching Assistant at the Department of Herbal Medicine, KNUST

World Diabetes Day was coined by the World Health Organization (WHO) and the International Diabetes Federation (IDF) in 2006. It has since been celebrated every year on November 14th.

Its purpose has been to promote the need to take coordinated and concerted actions to confront diabetes as a critical global health issue.

Diabetes has now become one of the world’s leading non-communicable diseases that affect the body’s ability to make or use insulin.

There are three main types of diabetes – type 1, type 2 and gestational. The body’s blood sugar levels are remarkably constant and rarely outside the range of 3.5?8.0 mmol/L but if an individual record continues fasting blood sugar over 8 mmo1/L or a random value over 11.1 mmo1/L the person is said to be diabetic.

Common symptoms include frequent urination, fatigue, weight loss, slow wound healing, blurry vision and frequent infections. Diabetes if left untreated may lead to nerve, kidney and eye damage, hearing impairment, foot gangrene, miscarriages, stroke and Alzheimer disease among others.

Significant number of Ghanaians are known to suffer from this disorder with the prevalence increasing with age and being higher in urban than in rural areas. Most patients often struggle to make the necessary lifestyle changes to control blood sugar levels, and most current medications have also been known to have some unfavorable adverse effects.

Role of Herbal medicines

Herbal medicines have over the years played an important role in the management of diabetes and its related complications. Clinical studies and various researches have proven the effectiveness of some medicinal plants and herbal formulations in the management of the disease.

Typical among them include: Charantia mormodica – Bitter melon (Asante twi: Nyanya), Ageratum conyzoides- Goat weed (Asante twi: Guakuro), Azadirachta indica -Neem (Asante twi: Dua Gyane), Bridelia micrantha- Bridelia (Asante twi: Opam fufuo), Hymenocardia acida- Heart fruit (Asante twi: Duakokowa), Morinda lucida – Brimstone tree (Asante twi: Bronyadua Konkroma), Moringa oleifera -Drumstick Tree (Ewe: Babatsi) and Tetrapleura tetraptera- Aidan fruit (Asante twi: Prekese).

The anti-hyperglycemic effects that result from treatment with some of these plants is often due to its ability to improve the performance of pancreatic tissue, which is achieved by increasing insulin secretions or reducing the intestinal absorption of glucose.

Research suggests that medicinal plants do not only promote normal blood sugar levels (normoglycaemia) but are also effective for the management of other conditions and complication associated with it.

Medicinal plants like Baphia nitida -African sandalwood (Asante twi: Odwen) and Spathodea campanulata –African tuliptree (Asante twi: Kokoanisuo) are recommended for the management of diabetic wound, Morinda lucida – Brimstone tree (Asante twi: Bronyadua Konkroma) for diabetic retinopathy, Terminalia catapa –Indian almond (Asante twi: Abrofo nkate?) for diabetic nephropathy with amnesia and Theobroma cacao –Cocoa (Asante twi: Kookoo) for diabetic neuropathy.

As we celebrate World Diabetes Day to promote the importance of taking coordinated and concerted actions

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New Game Changers In Medicine Episode About The Discovery Of Insulin Premieres On World Diabetes Day, November 14

NEW YORK, Nov. 12, 2020 /PRNewswire/ — Game Changers in Medicine, the new monthly podcast from Dramatic Health, premieres its fifth  episode Insulin: The lucky coin toss and improbable partnership that led to this life-saving elixir on World Diabetes Day, November 14, 2020. Insulin was discovered almost 100 years ago and has been saving the lives of patients with diabetes ever since. Currently, more than 460 million people worldwide suffer from some form of diabetes. Produced by Dramatic Health co-founder and CEO Sean T. Moloney, the series is hosted by renowned medical futurist Dr. Rubin Pillay of the University of Alabama at Birmingham (UAB).

For details on the podcast series, visit www.gamechangersinmedicine.com 

The Dramatic Health and Game Changers in Medicine teams have gathered a distinguished group of experts to discuss the science and serendipity behind the discovery of insulin, and to offer their perspectives on the ongoing search for a cure for diabetes. Participants in Insulin: The lucky coin toss and improbable partnership that led to this life-saving elixir include:  Jay S. Skyler, MD, MACP is currently a Professor of Medicine, Pediatrics, & Psychology, in the Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Miami Leonard M. Miller School of Medicine. He served as Director of that division from 2000 to 2004. He is Deputy Director of Clinical Research and Academic Programs at the Diabetes Research Institute. Grant Maltman, curator of the Banting House National Historic Site of Canada, in London, Ontario, coordinates cultural resource management and heritage presentation at Banting House–the birthplace of insulin. Toby Smithson, MS, RDN, CDE is a registered dietitian nutritionist (RDN) and certified diabetes educator (CDE) who has successfully managed her own Type 1 diabetes for more than 45 years.

According to Executive Producer Sean Moloney, “We have an abundance of material, including an interview with Dr. H. Franklin Bunn, the hematologist at Harvard Medical School, who co-discovered the hemoglobin A1c, a major diagnostic indicator of prediabetes and diabetes.  Dr. Bunn appeared in the premiere episode of Game Changers in Medicine last July.” A bonus episode of “Insulin: The lucky coin toss and improbable partnership that led to this life-saving elixir will be released at the end of November. 

Dramatic Health, a national healthcare video company, is the producer of the six-part podcast series Game Changers in Medicine. Previous episodes have included: the premiere podcast about Vitamin K and an enterprising Boston house doctor; the creation of a smallpox vaccine and its parallels to today’s urgent search for a COVID-19 vaccine; the history of the blood thinner warfarin, a rat poison turned game-changer in cardiology, and the development of the X-ray.  All episodes, a series backgrounder, and additional material about the podcast series are available at  www.gamechangersinmedicine.com and can be accessed wherever you find your podcasts.


Contact: Mark G. Auerbach. [email protected]

For additional details on the episode participants:
Diabetes Research Institute Foundation.

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American College of Lifestyle Medicine Launches Bill of Rights to Raise Awareness of Lifestyle Medicine’s Role in Type 2 Diabetes Informed Consent and Treatment

The Bill of Rights is a companion to ACLM’s recently launched “Reversing Type 2 Diabetes and Insulin Resistance with Lifestyle Medicine” 18-hour, 20-module, evidence-based CME/CE accredited online course for physicians and health professionals. This is the first comprehensive educational curriculum offered to equip physicians and other health professionals to treat and reverse type 2 diabetes and insulin resistance.  In addition, ACLM recently published a position paper, “Type 2 Diabetes Remission and Lifestyle Medicine: A Position Statement from the American College of Lifestyle Medicine.” ACLM will also present a free webinar, “The Reversibility of Type 2 Diabetes with Lifestyle Medicine—Q & A” on Thursday, Nov. 12 at 12 p.m. CST.

ACLM defines Lifestyle Medicine as the use of an evidence-based, whole food, plant-predominant dietary lifestyle, regular physical activity, restorative sleep, stress management, avoidance of risky substances and positive social connection as a primary therapeutic modality for treatment, reversal and prevention of chronic disease. Addressing lifestyle is the first step in type 2 diabetes and other chronic disease treatment and management guidelines, but it has been overlooked due to a lack of physician training in lifestyle, barriers to practice and a lack of consumer understanding. 

“We believe that a patient does not give fully informed consent if this option is not presented to them at the time of diagnosis,” said ACLM Founding President John Kelly, MD, DipABLM, lead faculty for the new course. “COVID-19 has highlighted the vulnerabilities created by type 2 diabetes, amplifying the urgent need to restore health to those impacted by this lifestyle-related chronic disease, as opposed to simply managing it.”

“COVID-19 has exposed the long-standing issue of racial health disparities in America, as people of color have been disproportionally affected by the pandemic,” said ACLM President Cate Collings, MD, DipABLM.  “While the causes of racial health disparities are many, and include the range of social determinants of health, the most devastating impact is from the significantly higher incidence of chronic disease, most notably type 2 diabetes.

“If you are talking about racial health disparities and are not focused on the disparate impact of type 2 diabetes, you are missing the heart of the matter.”

“Truly addressing racial health disparities will only happen when our nation recognizes the role of lifestyle and trains its clinicians accordingly, fully informs patients, removes the barriers to practicing Lifestyle Medicine and rewards physicians and health professionals for restoring health rather than merely managing disease,” said Kelly. “ACLM is actively addressing each of these areas.”

Diabetes has a devastating impact on the quality of life of millions of Americans.  Treatment for diabetes is also a major contributor to the country’s health care spending. According to the Centers for Disease Control and Prevention, 90 percent of the nation’s $3.3 trillion in annual health care expenditure pays for the treatment of chronic health conditions, including type 2 diabetes. In the United States

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HEALTH AND FITNESS: Diabetes 101 | Features

Diabetes is among the fastest-growing health conditions in the United States. Over 30 million adults have diabetes, with 1.5 million new cases each year. If you include prediabetes, which tends to lead to diabetes if untreated, over 100 million Americans are affected. Fortunately, most cases of diabetes can be treated or prevented through healthy eating, weight control, and regular exercise. Since November is American Diabetes Month, this seems like a good time to raise awareness about the prevention, treatment, and consequences of this serious medical condition.

Diabetes mellitus is a metabolic disorder characterized by high blood glucose (sugar) caused by a lack of insulin production or impaired insulin action. The lack of insulin production can be caused by an autoimmune disorder that damages the pancreas. This typically occurs during childhood, as in type 1 or “juvenile” diabetes, but it can occur in adults, a condition called latent autoimmune diabetes of adulthood (LADA). For both types, injected insulin is required to control blood glucose.

More commonly, diabetes is caused by the body’s cells not responding to the insulin that is produced, a condition called insulin resistance. This is called type 2 diabetes and is typically caused by some combination of obesity, particularly excess abdominal fat, and physical inactivity.

Diabetes can be diagnosed based on a fasting blood glucose test, taken 8–12 hours after a meal, usually in the morning. Another test is an oral glucose tolerance test in which blood glucose is measured for two hours after drinking a special beverage containing glucose. This measures the body’s response to glucose. The hemoglobin A1C test is a long-term measure of blood glucose control. This is important because the higher the hemoglobin A1C level, the greater the risk of diabetes complications.

For most diabetics, the main treatment goal is to control blood glucose level to prevent serious complications including nerve damage, blindness, infection and amputation, heart attack, and stroke. This is typically accomplished through a combination of diet, exercise, and medications, with varying degrees of success. But “curing” diabetes is rare, so most patients require continued treatment.

Exercise is important for blood glucose control because exercise causes an increase in the uptake of glucose into cells and can improve glucose tolerance and insulin sensitivity. In addition, exercise has the added benefits of promoting weight loss and improving strength and fitness. Both aerobic and strength training are recommended, with a minimum goal of 30 minutes per day, every day.

Meal planning involves selecting healthy foods to help maintain consistent blood glucose levels while meeting energy needs for exercise and other activities. The dietary recommendations for preventing and treating diabetes are almost identical to the general recommendations for good health: Emphasize whole grains, fruits, vegetables, legumes, and low-fat meat and dairy and reduce unhealthy fats, added sugars, and salt.

The diet should also promote weight loss and weight maintenance, especially for overweight patients. The glycemic index (GI), a measure of how much a food raises blood glucose, can be helpful in dietary planning, but it

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Type 2 diabetes drug recalled over concerns medication contaminated with possible carcinogen

Metformin, a medication to treat type 2 diabetes, is facing a recall over concerns it has been contaminated with a possible cancer-causing substance. 

Nostrum Laboratories Inc., the maker of Metformin, announced it is voluntarily recalling two lots of the medication – Metformin HCl Extended-Release Tablets, USP 750 mg – because the lots have been found to contain above-acceptable limits of nitrosamine, also known as NDMA, a “probable human carcinogen,” per the recall announcement posted to the U.S. Food and Drug Administration’s (FDA) website on Monday. 

This isn’t the first time excess levels of NDMA in medications have prompted recalls. In the past, certain blood pressure and heartburn medications have been affected.

This isn’t the first time excess levels of NDMA in medications have prompted recalls. In the past, certain blood pressure and heartburn medications have been affected.

“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables,” per the announcement. 

No adverse events related to the recalled medications have been reported to date, the company said. 


The affected medications are packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01, per the announcement on the FDA’s website. Lot numbers are MET200101 and MET200301. Both lots have an expiration date of May 2022. 

“The product can be identified as an off-white oblong tablet debossed with ‘NM7.’ Metformin HCl Extended-Release Tablets, USP 750 mg was distributed nationwide to wholesalers,” per the announcement. 


“Nostrum Laboratories Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended-Release Tablets, USP 750 mg, which is being recalled, should return to place of purchase. Consumers should consult a health care professional to obtain a replacement or a different treatment option,” the announcement reads. “It could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professional. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking this drug product.”


Consumers with additional questions can contact Nostrum Laboratories Inc. Medical Affairs at 816-308-4941 or email [email protected] 

This isn’t the first time excess levels of NDMA in medications have prompted recalls. In the past, certain blood pressure and heartburn medications have been affected.

Source Article

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Type 2 diabetes drug metformin recalled over contamination with possible carcinogen

Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it is voluntarily recalling its metformin HCl extended release tablets, USP 750 mg, according to a recall posted by the US Drug & Food Administration.
Testing revealed levels of nitrosamine, or NDMA, above acceptable limits in the recalled tablets.
The chemical NDMA is considered a possible carcinogen by the US Environmental Protection Agency. It’s an organic chemical used to make liquid rocket fuel and it can be a byproduct of manufacturing, including pharmaceutical manufacturing. It’s also found in water and foods, including meats, dairy and vegetables.

NDMA has also been found in certain blood pressure drugs and antacid.

This is the latest in a series of metformin recalls linked to potentially cancer-causing contaminants in the drugs.

Nostrum said it has not received any reports of adverse events related to the recall. The company also said it was notifying its distributors and arranging for the return of the recalled product.

The impacted product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg lots are under NDC 29033-056-01, lot numbers MET200101 and MET200301 which expiration date 05/2022. It can be identified as an off-white oblong tablet debossed with “NM7.”

More than 34 million people in the US have diabetes — about 1 in 10 — with approximately 90 to 95% of them being diagnosed with type 2 diabetes, according to the US Centers for Disease Control and Prevention.

Source Article

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American Diabetes Association Unveils Scientific Review on Social Determinants of Health and Diabetes

American Diabetes Association Unveils Scientific Review on Social Determinants of Health and Diabetes

PR Newswire

ARLINGTON, Va., Nov. 2, 2020

ARLINGTON, Va., Nov. 2, 2020 /PRNewswire/ — Today, the American Diabetes Association® (ADA), the nation’s leading organization for all people living with diabetes, published a scientific review addressing social determinants of health (SDOH) and diabetes. Toward the goal of understanding and improving the health of people with diabetes through addressing SDOH, a writing committee—convened by the ADA—reviewed past evidence and research on diabetes risk and outcomes, as well as the impacts of interventions in these determinants.

“People living with diabetes face many challenges. Some of these relate to the disease itself, but increasingly we recognize the importance of many social determinants,” said Robert A. Gabbay, Chief Scientific and Medical Officer for the ADA. “The scientific review not only defines these issues but shines a bright light on the resulting health disparities and articulates an important research agenda to address these issues. The release of this important scientific review underlines the American Diabetes Association’s commitment for #HealthEquityNow.”

As defined by the World Health Organization (WHO), social determinants of health are the conditions in which people are born, grow, live, work, and age. These circumstances are shaped by the distribution of money, power, and resources at global, national, and local levels. The social determinants of health are mostly responsible for health inequities—the unfair and avoidable differences in health status seen within and between countries. The COVID-19 pandemic has further exposed unequal vulnerabilities that impact racial and ethnic minority groups and disadvantaged communities. Understanding and mitigating the impact of SDOH for people with diabetes are priorities due to disease prevalence, economic costs, and disproportionate population burden. 

The ADA committee summarized the following recommendations from international and U.S. national committees that have convened to provide guidance on SDOH intervention approaches: 

  • establish consensus core SDOH definitions and metrics,

  • examine specificities in SDOH pathways and impacts among different populations with diabetes,

  • prioritize a next generation of research that targets SDOH as the root cause of diabetes inequities,

  • use dissemination and implementation science to ensure SDOH considerations are embedded within diabetes research and evaluation studies, and

  • train researchers in methodological and experimental techniques for multisector and next generation SDOH intervention studies.

“This is a critical time in our nation’s history. As researchers and providers, we have the opportunity to advance solutions to the longstanding inequities that impact diabetes and other health conditions,” said Dr. Felicia Hill-Briggs, past ADA President of Health Care and Education and Chair of the SDOH writing committee. “Through this SDOH review, the American Diabetes Association is taking an important step toward acknowledging and setting the stage for the important research, policy, and implementation work that must be done in order to change the trajectory of inequity.”

The paper begins with a general outline of key definitions and SDOH frameworks and includes a literature review that focuses primarily on U.S.-based studies of adults with diabetes and on five

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UK Diabetes Clinicians Urged to Embrace ‘Time in Range’

A new ‘best practice guide’ urges UK healthcare professionals to embrace the ‘time in range’ metric for patients with diabetes who use continuous glucose monitoring (CGM), particularly in light of the COVID-19 pandemic.

Time in range: a best practice guide for UK diabetes healthcare professionals in the context of the COVID-19 global pandemic, was published October 19 2020 in Diabetic Medicine by Dr Emma Wilmot of the diabetes department, Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, and colleagues. The document is a publication of the Diabetes Technology Network (DTN) UK, part of the Association of British Clinical Diabetologists (ABCD). 

Real-time CGM

In June 2019, an international consensus report established the ‘time in range’ concept – the proportion of time a person’s blood glucose falls within a prescribed range – as a clinical metric for patients with type 1 or type 2 diabetes who use either real-time CGM (rtCGM) or intermittently scanned CGM (isCGM), also called ‘flash glucose monitoring’. The latter, the Abbott FreeStyle Libre, is the one most commonly used in the UK, although the NHS in England has recently authorised the Dexcom G6 rtCGM for use during pregnancy.  

The new guidance aims to clarify the intent and purpose of the international consensus recommendations and provide practical clinical and technical advice for use of time in range in UK diabetes care, particularly in the context of the COVID-19 pandemic, co-author Pratik Choudhary, professor of diabetes at the University of Leicester, told Medscape Medical News.

“Even though FreeStyle Libre has been widely rolled out and people are seeing the reports, we felt that a locally-published paper by local leaders of the DTN was needed to get people to start thinking about time in range. People are still fixated on haemoglobin A1c (HbA1c) and glucose of 5 [mmol/L],” Prof Choudhary said.

International Guidelines

The paper reviews and provides rationale for the international guidelines, which recommend generally that more than 70% of glucose readings should fall within a blood glucose range of 3.9-10.0 mmol/L, with modifications for children, older adults, and pregnant women.  

“It’s a huge mindset [change] from saying your target is 5 [mmol/l] to saying you’ve got a target range. It’s saying you’ve got an allowance of 30%, so if you screw up a little bit it’s not a disaster. It will balance out. That’s the narrative we want to put out there,” Prof Choudhary explained.

A UK-based audit on the use of FreeStyle Libre conducted by ABCD showed significant improvements in HbA1c, reduced hospital admissions, and lower levels of diabetes-related distress in patients with type 1 diabetes. Updated data from that study were published in the September 2020 issue of Diabetes Care.

Remote Monitoring

The new document emphasises that time in range is meant as an adjunct to HbA1c rather than a surrogate, and discusses the correlations between the two values and their respective association with diabetes-related outcomes. However, because the COVID-19 pandemic has reduced the capacity for in-person visits including blood tests,

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Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trials of Setmelanotide in The Lancet Diabetes & Endocrinology

Largest studies in POMC and LEPR deficiency obesities demonstrate that treatment with setmelanotide reduced body weight and hunger

BOSTON, Oct. 30, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, announced today that results from two pivotal Phase 3 studies evaluating setmelanotide in proopiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity were published in The Lancet Diabetes & Endocrinology. As previously reported, data from the studies demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, led to statistically significant and clinically meaningful reductions of weight and hunger.

“Results from Rhythm’s pivotal Phase 3 studies, which are the largest studies to date in POMC and LEPR deficiency obesities, provide evidence regarding the safety and efficacy of setmelanotide and we believe they validate its potential long-term use as a novel treatment for severe obesity and hyperphagia,” said co-author Peter Kühnen, M.D., Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Germany. “It is important to recognize the signs of these rare genetic disorders because we may soon have a targeted treatment option available for the first time for obesity disorders caused by impairments of the MC4R pathway.”

Rhythm initially reported positive topline data from the Phase 3 studies in August 2019 and subsequently presented updated data in a late-breaking research forum during the 37th Annual Meeting of The Obesity Society at ObesityWeek® 2019.

Eight of 10 participants with POMC deficiency obesity (80%; P<0.0001 compared with historical data) and five of 11 participants with LEPR deficiency obesity (45%; P=0.0001 compared with historical data) achieved at least 10 percent weight loss at approximately one year. The mean percent change in “most hunger” score in participants aged 12 years and older was -27.1 percent (n=7; P=0.0005) in POMC deficiency obesity and -43.7 percent (n=7; P<0.0001) in LEPR deficiency obesity. Consistent with prior clinical experience, setmelanotide was generally well-tolerated in both trials. The most common adverse events were injection site reaction, skin hyperpigmentation, and nausea.

“These results are significant because, as we know from natural history data, individuals living with POMC or LEPR deficiency obesity consistently experience substantial weight gain each year beginning in early childhood, and we would not expect any of these patients to be able to achieve 10 percent weight loss over the course of a year without continued treatment,” said co-author Karine Clément, professor of nutrition at Pitié-Salpêtrière hospital and Sorbonne University in Paris. “These data and the significant unmet need to address the obesity and hyperphagia caused by rare genetic disorders of obesity underscore the importance of testing for genetic variants that may impair MC4R activation and lead to severe obesity.”

In May 2020, Rhythm announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for setmelanotide for the treatment of POMC deficiency obesity and LEPR deficiency obesity, granted Priority Review of the NDA and assigned a Prescription Drug

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