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Biohaven Pharmaceuticals And Weill Cornell Medicine Collaborate To Initiate Proof Of Concept Trial With CGRP Receptor Antagonist In Plaque Psoriasis

NEW HAVEN, Conn., Nov. 16, 2020 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates, today announced that Dr. Richard Granstein, M.D., Chairman of Dermatology at Weill Cornell Medicine in New York City, will initiate an investigator-led clinical trial with a Biohaven CGRP-receptor antagonist for the treatment of plaque psoriasis.

Vlad Coric M.D., Chief Executive Officer of Biohaven commented, “Biohaven’s neuroinnovation portfolio is powered by a combination of strong science and patient need. Dr. Granstein is a foremost expert in the CGRP-related biology of dermatological conditions, which has been a focus of his research for nearly two decades. We are committed to following the science of CGRP-receptor antagonism across disease states and Dr. Granstein’s pioneering work affirms that neuropeptide CGRP may play a critical role in plaque psoriasis.  This scientific foundation, together with a recognized need for more safe and effective treatment options for people suffering with psoriasis, has inspired our meaningful collaboration.”

The investigator-led clinical trial will explore whether treatment with one of Biohaven’s CGRP-receptor antagonists will reduce the severity of disease and percentage of area affected as measured by patients’ Psoriasis Activity Severity Index (PASI) score after 16 weeks of treatment as compared to placebo. In addition, the study will assess the potential impact on itch and patient quality-of-life measures.

Dr. Granstein commented, “The animal models and clinical reports of CGRP in psoriasis suggest that CGRP receptor antagonism could alleviate the severity of disease. This clinical study will enable us to evaluate this therapeutic candidate’s efficacy, the findings of which will be the first step in bringing this novel, translational idea to patients. Pathways by which the nervous system exerts regulatory effects on immunity may prove to provide important druggable targets for a range of inflammatory disorders.”

Biohaven’s CGRP-receptor antagonist platform includes Nurtec™ ODT (rimegepant) and zavegepant. Nurtec ODT™ was approved by the FDA in February 2020 for the acute treatment of migraine. Biohaven filed a supplemental New Drug Application (sNDA) for Nurtec™ ODT (rimegepant) for the preventive treatment of migraine earlier this year which was accepted for review in October 2020. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021.

Zavegepant is a third generation, high affinity, selective and unique, small molecule CGRP receptor antagonist that is structurally distinct from rimegepant. Zavegepant may be suitable for multiple routes of delivery including nasal, subcutaneous, inhalation or oral administration. Positive results were announced in late 2019 from a Phase 2/3 study of intranasal zavegepant in the acute treatment of migraine, and the company plans to initiate an additional Phase 3 study before the end of 2020. Biohaven also initiated a Phase 2 trial with intranasal zavegepant in April 2020 in collaboration with Thomas Jefferson University in Philadelphia, PA, to study the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response in pulmonary function which in

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medicine

Zhittya Genesis Medicine Announces It Has Been Approved to Initiate Clinical Trials in Mexico …

LAS VEGAS, Oct. 15, 2020 (GLOBE NEWSWIRE) — Zhittya Genesis Medicine, Inc. (Zhittya), a private company, announces that it will initiate clinical trials in Mexico to test a medical hypothesis that has been advanced over the last five years that ALS may be caused by vascular disruption in the areas of the brain which house motor neurons, those neurons which become dysfunctional in patients suffering from ALS. The hypothesis is simply that the micro-vascularization in that area of the brain is blocked or narrowed, restricting the flow of blood needed to nourish the motor neurons. Just as with heart disease, where blockage of coronary arteries can lead to angina and heart attacks, that same process is now thought to underlie the development of ALS.

Dr. Jack Jacobs, Zhittya’s President and Chief Science Officer will be giving a free Zoom webinar on this topic entitled: “Amyotrophic Lateral Sclerosis (ALS): Is Therapeutic Angiogenesis a Potential Treatment to Reverse this Disease?” This webinar will broadcast on Thursday, October 29, 2020 at 9:00 am Pacific time, 12 noon Eastern time.

Click Here to Register for this Webinar

Zhittya is developing a biological drug which in previous US FDA-authorized clinical trials has demonstrated it can trigger “therapeutic angiogenesis” or the growth of new blood vessels in ischemic tissues. Zhittya has prepared a White Paper entitled: “Human FGF-1 as a Potential Treatment for Amyotrophic Lateral Sclerosis (ALS)”, which is available to all, free of charge, by emailing: [email protected]

Daniel C. Montano, CEO of Zhittya stated, “I believe we are truly on to something here. Over the last three years, we have continually uncovered data which enhances our belief that therapeutic angiogenesis might be a viable breakthrough treatment for patients that suffer from ALS. If, as we believe, ALS is initiated by micro-vascular disruption in the brain, we hope our molecule can do in the brain, what it has already demonstrated it can do in the US FDA-cleared heart trial, namely, grow new blood vessels.”

Dr. Jack Jacobs added, “ALS is a progressive and fatal neuromuscular disease and the majority of ALS patients die within 2–5 years of receiving a diagnosis. There is no known definitive cause of ALS and hereditary forms of the disease only account for 5%–10% of cases. No cure has been identified and the lack of proven and effective therapies for ALS is an ongoing challenge. There are now multiple lines of evidence that have established that angiogenesis is deficient in this disease, leading directly to the death of motor neurons. I believe therapeutic angiogenesis may be a potentially novel way to halt the progression of ALS and we are pleased that the Mexican regulatory authorities have given us permission to test our biological drug candidate in subjects with ALS.   

About Zhittya Genesis Medicine

Zhittya’s management has been working to advance these medicines for over 21 years and many tens of millions of dollars have been expended in preclinical and clinical studies. Zhittya’s medicine initiates a biological process in the human body referred

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