Psychedelics constitute a novel and heterogeneous class of therapeutic candidates that is starting to take shape via clinical data. Just in the past few days, critical and successful clinical readouts have been announced by Compass Pathways and Atai Beckley, recently Gilgamesh and Transcend had positive clinical results. Cybin has data coming soon. Lykos Therapeutics, whose FDA rejection colored the view of the field last year, is birthing a new iteration with new management and funding. The current federal administration has surprisingly embraced the concept of psychedelic therapies, and the push for accelerated reviews is likely to benefit this class.
This review assesses over fifty companies, including Atai Beckley, Compass, Gilgamesh, Cybin, Enveric, GH Research, Lykos, Reunion, Terran, Freedom, and MindMed. Pain programs from Ceruvia and Sonic Therapeutics are included. Psychoplastogen programs, from companies like Delix, Psilera, AbbVie/Gilgamesh, JNJ/Intra-Cellular, and more, are also reviewed. The Summer issue includes an updated review of Compass Pathways, whose limited data reveal from its first PhIII was misinterpreted by many observers.
The Parkinson’s area continues to be the domain in neurodegeneration where the most mundane (but meaningful) of symptomatic therapies are being developed alongside the most adventuresome and risky interventions, including cell therapies (Aspen, Bayer) and gene therapy (e.g. Lilly/Prevail, Neurocrine/Voyager). Alpha-synuclein continues as a target of interest, though its merit as a target has been disappointing, with Roche/Prothena continuing down the mAb road to disappointment. GBA (e.g. Lilly/Prevail, BIAL, and Vanqua) and LRRK2 may be the most promising genetic targets, and LRRK2 appears to be potentially relevant to idiopathic PD as well (e.g. Biogen/Denali, Neuron23). Other neuroprotective options are in development by companies including AbbVie/Mission and NRG Therapeutics. In terms of improved symptomatic options, AbbVie’s tavapadon appears very promising.
Third is Stroke, still off-menu for most larger companies, but attracting more interest from small companies based on seeking complementary roles alongside mechanical thrombectomy and thrombolysis. NoNO Therapeutics has compelling evidence of partial neuroprotection for nerinetide, and is now working on a tPA-friendly next iteration: Programs from AptaTargets, Revalesio, and Simcere have shown potential.
The Summer issue also comments on Supernus’ acquisition of Sage Therapeutics, Alto Neuroscience’s several announcements and program developments, Coya’s interim data in FTD, and much more.
110 pages.
A one-year (1-5 user) subscription to NeuroPerspective is $3300. A 6-10 user subscription is $5500. Other customized userbase and startup pricing options are available. The Summer issue is being made available as a single-issue purchase, for $900, available for online purchase and download at https://www.niresearch.com/onlinestore.html.
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