Biogen

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Biogen to Present Positive Phase 2 Systemic Lupus Erythematosus Data at American College of Rheumatology 2020 Meeting

  • In Phase 2 LILAC study, BIIB059 demonstrated a statistically significant reduction in joint disease activity compared to placebo in systemic lupus erythematosus patients

  • Positive results build on previously reported cutaneous lupus erythematosus data and underscore Biogen’s commitment to the lupus community

  • Systemic lupus erythematosus is a chronic and debilitating autoimmune disease that affects multiple organ systems, with periods of illness or flares alternating with periods of remission

CAMBRIDGE, Mass., Nov. 03, 2020 (GLOBE NEWSWIRE) — Today, Biogen Inc. (Nasdaq: BIIB) announced positive data from the 24-week systemic lupus erythematosus (SLE) portion of the Phase 2 LILAC study (part A) demonstrating that BIIB059 (anti-BDCA2) was associated with a statistically significant reduction in total active joint count. The study evaluated the efficacy and safety of BIIB059, a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed exclusively on plasmacytoid dendritic cells. These data, along with the previously reported findings from the cutaneous lupus erythematosus (CLE) portion of the LILAC study, will be presented at the American College of Rheumatology’s ACR Convergence 2020, being held virtually from November 5-9, 2020.

“People living with systemic lupus erythematosus suffer from chronic and debilitating symptoms that impact multiple organ systems as well as their social and emotional well-being,” said Nathalie Franchimont, M.D., Ph.D., Vice President and Head of the Multiple Sclerosis and Immunology Development Unit at Biogen. “These latest data highlight the potential of BIIB059 to impact disease activity and, together with the earlier cutaneous lupus erythematosus findings, reflect Biogen’s commitment to drive therapeutic innovation for lupus patients who have limited treatment options.”

The Phase 2 LILAC study (part A) met its primary endpoint of reducing joint disease activity in individuals with SLE, as measured by total active joint count. A statistically significant difference in change from baseline of 3.4 in total active joint count was observed at week 24 between participants who received BIIB059 450 mg administered subcutaneously every 4 weeks with an additional dose at week 2 versus placebo (p=0.037). Total active joint count is the total number of tender or swollen joints. Tender or swollen joints are one of the most common symptoms impacting quality of life in people living with SLE.

The study also met the secondary endpoint of SLE Responder Index-4 (SRI-4), resulting in an overall reduction in disease activity in participants who received BIIB059 versus placebo. There was a 26.35 percent higher SRI-4 response rate among participants who received BIIB059 (56.77 percent) versus placebo (30.42 percent [odds ratio=3.49, p=0.003]). The SRI-4 is a composite measure comprising criteria from different internationally validated indices of systemic disease activity.

An additional secondary endpoint from part A of the study in individuals with SLE evaluated the effect of BIIB059 on skin disease activity using the CLE Activity Disease Area and Severity Index-Activity (CLASI-A) score in a subgroup of participants with a baseline CLASI-A score of ≥8. There was a 20 percent higher response rate among participants who received BIIB059 (69.10 percent) versus placebo (49.10 percent) who achieved at

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U.S. Experts to Review Biogen Drug That Could Be First New Alzheimer’s Treatment in Decades | Top News

(Reuters) – U.S. health experts this week will decide whether to recommend approval for Biogen Inc’s

Alzheimer’s drug, which could become the first new treatment for the mind-wasting disease in decades even as serious questions persist over whether data show if it works.

In a field littered with unrelenting failure, Biogen believes in aducanumab it has the first drug that can treat an underlying cause, and therefore slow progression, of Alzheimer’s. But its path to approval has been anything but smooth or assured.

Biogen abruptly ended clinical trials of aducanumab last year after an early look at trial results showed it was not effective. Last October, the company shocked many Alzheimer’s experts by reversing course, saying that a new analysis showed aducanumab could help patients with early-stage disease preserve their ability to function independently for longer. In July, Biogen filed for approval from the Food and Drug Administration.

Now the agency faces tremendous pressure to approve a treatment option for millions of Americans suffering from Alzheimer’s and the millions more expected to face it in coming years.

Patient advocates say the need for a new Alzheimer’s treatment that could help people remain independent is heightened by the coronavirus pandemic, which has killed more than 229,000 people in the United States, including tens of thousands of seniors in nursing homes.

“The pandemic came and it changed everything,” said Russ Paulsen, chief operating officer at patient advocacy group UsAgainstAlzheimer’s. “We need something to keep people out of nursing homes.”

A committee of outside advisers to the FDA will discuss aducanumab on Nov. 6. The agency’s final decision is expected by March. European health regulators have also accepted the drug for review.

Charles Flagg, a 79-year-old retired minister from Jamestown, Rhode Island, had been enrolled for years in a trial of aducanumab before it was stopped. He started receiving the drug again in August as part of a follow-up study, according to his wife Cynthia Flagg.

“He’s not 100 percent himself, but overall I’m not dealing with someone that needs to be led around or be in a care home,” Flagg said.

Aducanumab, an antibody designed to remove amyloid plaques from the brain – a strategy tried with many failed Alzheimer’s drugs – would reap billions of dollars in sales if approved.

Biogen, along with partner Eisai Co Ltd <4523.T>, is one of the last large drugmakers pursuing treatments for a disease that afflicts nearly 6 million Americans and millions more worldwide. Biogen estimates about 1.5 million people with early Alzheimer’s in the United States could be candidates for the drug.

Late last year, Biogen said one of its two pivotal studies of aducanumab showed a statistically significant benefit at slowing cognitive and functional decline in patients with early Alzheimer’s. A second trial failed to achieve that goal, but did show a benefit for a subset of patients who were given a high dose for at least 10 months.

In March, it opened a follow-up long-term safety study to 2,400 people who had

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Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference

Biopharma stocks, which started the week on a firm footing, lost momentum mid-way through amid market-wide sell-off triggered by waning stimulus hopes.

The week was a quiet one from the perspective of news flow. Johnson & Johnson (NYSE: JNJ) was in the news for both right and wrong reasons. The company’s Phase 3 trial of its coronavirus vaccine was paused due to a trial participant contracting an unexplained illness. On a positive note, the company reported solid quarterly results and lifted its guidance.

Pfizer Inc. (NYSE: PFE), meanwhile, stayed above political pressure and provided a realistic timeframe for filing for emergency use authorization for its vaccine candidate.

Avenue Therapeutics Inc (NASDAQ: ATXI) shares fell from $11 to just under $4 after FDA rejected its opioid pain drug on safety concerns.

Clinical trial disappointments led to Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) and Cyclerion Therapeutics Inc (NASDAQ: CYCN) shelving alpha-1 antitrypsin deficiency and sickle cell disease studies, respectively.

The week witnessed Nasdaq debuts by six biopharma companies, which collectively raised about $650 million in gross proceeds.

Here are the key catalysts for the unfolding week.

Conferences

American College of Chest Physicians’ CHEST Annual Meeting 2020, being held virtually: Oct. 18-21

The Prostate Cancer Foundation’s 27th Annual Scientific Retreat: Oct. 20-23

IDWeek 2020: Oct. 20-25

American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: Oct. 22-25 (early programs scheduled for Oct. 19-21)

32nd European Organisation for Research and Treatment of Cancer-the National Cancer Institute- the American Association for Cancer Research, or EORTC-NCI-AACR, Symposium: Oct. 24-25

PDUFA Dates

Zosano Pharma Corp’s (NASDAQ: ZSAN) NDA for its migraine drug Qtrypta has a PDUFA action date of Oct. 20. With the company disclosing in late September that it has received a discipline review letter, which raised two concerns about the clinical pharmacology section of the NDA, a decision by the d-day seems unlikely.

The FDA is set to rule on Spectrum Pharmaceuticals, Inc.’s (NASDAQ: SPPI) BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is Oct. 24.

Clinical Readouts

Pfizer Inc. (NYSE: PFE) is scheduled to present at the ID Week 2020 full results of the pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) will present at the ASN meeting results from the ILLUMINATE-B pediatric Phase 3 study of lumasiran in treating primary hyperoxaluria type 1.

Omeros Corporation (NASDAQ: OMER) is due to present final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The presentation, in the form of a webcast, is scheduled for Oct. 22.

Mustang Bio Inc (NASDAQ: MBIO), founded by Fortress Biotech (NASDAQ: FBIO), is scheduled to present at the Prostate Cancer Foundation’s annual scientific retreat initial Phase 1 data on CAR-T cell therapy MB-105 in patients with PSCA-positive metastatic castration-resistant prostate cancer. The presentation is fixed for Oct. 23.

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