Vivoryon - Crucial Readout Expected in Q124 (Sponsored Research, TP EUR 33, 14 pgs)
Vivoryon (AEX: VVY) is a German biotech developing a highly differentiated drug, varoglutamstat, for early Alzheimer’s Disease (AD). In the Ph2a SAPHIR trial, varo’ demonstrated strong signs of efficacy across multiple independent markers for improving working memory and synaptic activity. The ongoing Ph2b VIVIAD study is designed to confirm and further elucidate the cognitive benefits using validated endpoints (Cogstate and A-IADL), with a readout expected in Q124. If this confirms a meaningfully slower cognitive decline, then an accelerated approval (AA) in AD is possible by 2025, which would be transformative for the company, as varo’ does not cause ARIA, unlike current mAB treatments. To support approval, the VIVA-MIND study, which uses the regulatory endpoint CDR-SB, could convert to a P3, in line with the FDA’s requirement for a confirmatory trial to be underway for an AA.For access to the full note, please contact Naresh Chouhan ( )
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