Biogen validates anti-tau approach at AAIC, psychedelics full speed ahead, ATTR-CM shakeup

At the Alzheimer's Association International Conference (AAIC) in London, Biogen presented new data for its anti-tau candidate diranersen, developed in partnership with Ionis Pharmaceuticals. While the Phase 2 trial missed its dose-related primary endpoint, it achieved "unprecedented" reductions in total tau in cerebrospinal fluid and brain tau pathology, according to Szofia Bullain, Biogen's vice president of Alzheimer’s Disease and Dementia Clinical Development. This validates the tau-targeting approach for Alzheimer's disease.

Additionally, Biogen announced FDA approval of a subcutaneous formulation of Leqembi (lecanemab) for initial doses, allowing at-home administration and differentiating it from Eli Lilly's Kisunla.

In the psychedelics space, Compass Pathways released more positive data for its psilocybin-based asset COMP360, showing clinically meaningful reduction in depression severity by six weeks in a late-stage trial. The data supports the company's rolling submission for approval. This follows Definium Therapeutics' promising results for an LSD-based treatment for major depressive disorder. The FDA also issued final guidance for psychedelics developers, signaling support for the novel drug class.

In ATTR-CM, Ionis and AstraZeneca reported that their antisense therapeutic Wainua failed a Phase 3 study, sending shockwaves through the field and affecting competitors such as Alnylam, BridgeBio, and Intellia Therapeutics.

In other news, Roche ended two Huntington's disease trials partnered with Ionis for an antisense oligonucleotide. This development could benefit Wave Life Sciences, which is developing a more selective ASO targeting only mutant huntingtin.

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