Biogen to drop gosuranemab development after Phase II failure

16th December 2019 (Last Updated December 16th, 2019 11:36)

Biogen has announced plans to discontinue the development of gosuranemab (BIIB092) after the drug failed to yield positive results in the Phase II PASSPORT clinical trial to treat progressive supranuclear palsy (PSP).

Biogen has announced plans to discontinue the development of gosuranemab (BIIB092) after the drug failed to yield positive results in the Phase II PASSPORT clinical trial to treat progressive supranuclear palsy (PSP).

Gosuranemab is a humanised monoclonal antibody designed to target and remove N-terminal tau. The drug is undergoing studies for its ability to slow disease progression in tauopathies.

Biogen obtained the drug under a licensing agreement with Bristol-Myers Squibb.

PASSPORT is a randomised, double-blind, placebo-controlled, parallel-group trial conducted to assess the safety and efficacy of intravenous BIIB092 in nearly 490 patients.

The primary objective is the efficacy of BIIB092, determined as a change in the PSP Rating Scale (PSPRS) at week 52 from baseline compared to placebo.

In addition, the trial evaluated the drug’s safety and tolerability by analysing the frequency of deaths, serious adverse events (SAEs), AEs leading to discontinuation and Grade 3 and 4 laboratory abnormalities.

The primary endpoint was not met, with gosuranemab failing to demonstrate statistical significance in the PSPRS at week 52. The drug did not show efficacy on major clinical secondary endpoints.

Based on the data, the company decided to end the drug’s development for PSP and other primary tauopathies.

Biogen chief medical officer and Research and Development executive vice-president Alfred Sandrock said: “We are disappointed with the efficacy results of the Phase II PASSPORT study.

“We remain unwavering in our commitment to advancing therapies that have the potential to address the significant unmet medical needs of people with neurodegenerative diseases who are faced with limited to no treatment options.”

Safety analysis of the Phase II trial revealed a profile generally consistent with prior studies.