Biogen’s investigational eye treatment fails to meet study goal

May 14 (Reuters) – Biogen Inc’s (BIIB.O) gene therapy for an inherited retinal disease that causes progressive vision loss has failed to meet a primary study goal, a development that further puts the focus on an upcoming decision regarding its ongoing Alzheimer’s disease drug review.

The investigational treatment, BIIB112, did not show significant improvement in an intermediate-to-late-stage study of retinal sensitivity in patients with X-linked retinitis pigmentosa, a rare eye condition for which no treatment is available. has been approved.

Biogen is betting on gene therapies to diversify its portfolio as its top-selling multiple sclerosis drug, Tecfidera, faces increased generic competition and uncertainty over the approval of its Alzheimer’s drug , aducanumab.

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It acquired BIIB112 as part of its $800 million deal with gene therapy company Nightstar Therapeutics, and recently signed a research collaboration with Capsigen to develop gene therapies for central nervous system and neuromuscular disorders.

The trial results will likely remind investors of the high-risk nature of Biogen’s pipeline, said RBC Capital Markets analyst Brian Abrahams, though the program has little relevance to the company’s future earnings.

“Investors are likely focused on aducanumab’s PDUFA (FDA decision date) next month.”

Aducanumab, considered a potential blockbuster if approved, has had a bumpy regulatory road.

The U.S. Food and Drug Administration (FDA) is expected to rule on the drug by June 7 after postponing it from March and the regulator’s outside experts voted against aducanumab last year.

BIIB112 showed positive trends in improving visual sharpness in low light conditions and Biogen is analyzing the comprehensive data to decide on next steps.

Shares of the company fell 1.6% in a broader, higher market.

The data from the study is the latest setback in the field of gene therapy in recent months.

In March, Roche (ROG.S) halted late-stage trials of its gene therapy for Huntington’s disease after an independent data monitoring board questioned whether the drug’s benefits outweighed its risks.

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Reporting by Mrinalika Roy in Bengaluru; Editing by Arun Koyyur

Our standards: The Thomson Reuters Trust Principles.


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