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AbbVie Stops an Anti-Tau Study and Biogen’s Studies May be in for Trouble

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AbbVie Stops an Anti-Tau Study and Biogen’s Studies May be in for Trouble

AbbVie terminated a clinical trial of its intravenously administered antibody, designed to slow the progression of Progressive Supranuclear Palsy (PSP), as it failed to show any benefit. This double-blind clinical trial, launched in 2017, had enrolled 378 patients in eight countries. On track to end in early 2020, an interim analysis revealed no benefit existed and that continuation of the study was futile. Ominous implications for Biogen PASSPORT study loom.

Biogen’s PASSPORT study, another trial focusing on monoclonal antibodies against PSP, continues. Similar in size and design to AbbVie’s ARISE study, PASSPORT started 6 months earlier reports PSP.org. Biogen hasn’t announced any plans to stop the trial. Their antibody, called “gosuranemab” is somewhat different than AbbVie’s investigational product. There were no adverse events announced for either product. The CurePSO organization reports it is “hopeful that gosuranemab will prove efficacious in slowing PSP progression.”

Biogen’s PASSPORT Study for PSP

The PASSPORT study is a Phase 2 study primarily seeking to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSO Rating Scale (PSPRS) at week 52. The study will also assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, safety adverse events (SAEs), adverse events (AEs) leading to discontinuation, and Grade 3 & 4 laboratory abnormalities.

The secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by change in baseline in Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by change in baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.

With 459 planned participants the study end date is scheduled for March 30, 2020. The sponsor lists up to 90 research sites but precludes identification.

What is BIIB092?

BIIB092 is a humanized IgG4 monoclonal anti-tau antibody. In April 2014 Bristol-Myers Squibb acquired iPierian, a biotechnology company that developed IPN007, an antibody against extracellular, N-terminally fragmented forms of tau (eTau) that were originally isolated from familial AD patient-derived pluripotent stem cells. The rationale for this approach is that eTau is proposed to be involved in the spread of the pathology in tauopathies and the antibody reportedly neutralizes the toxicity of eTau in mouse models of frontotemporal dementia. Secreted forms of tau were reported to cause neuronal hyperactivity, which could in turn increase Aβ production, fueling a feed-forward cycle. In 2017, Biogen licensed this antibody from BMS paying $300 million upfront.

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