FLHLF - Filament Health (FLHLF) - New Phase 2 Trial for PEX010 Approved To Begin In 1Q22

Additional Phase 2 Study Announced. Filament announced that Health Canada approved a new Phase 2 clinical trial to test PEX010 in persistent depressive disorder (PDD). The trial will test a 1 milligram microdose of PEX010 against placebo to determine safety and efficacy of the microdosing.Study Design Uses A Lower Dose. The Phase 2 trial will test a 1 mg dose of PEX-010, Filament’s botanically derived psilocybin. It is designed as a placebo-controlled study to test safety and efficacy, with an planned enrollment of about 100 healthy patients with PDD. The trial will be conducted at the Canadian Centre for Psychedelic Science and the University of Toronto, with funding from the Nikean Foundation.Phase 1 Study At UCSF Is Also Expected To Start Treatment In 1Q22. In late 2022, the Translational Psychedelic Research Program (TrP) at University of California San Francisco announced that it would be testing PEX010 in a Phase 1 trial. The study will have three arms to test the standard 25 mg dose of PEX001, an oral dose of psilocin, and a sublingual delivery formulation of psilocin. It is expected to begin treating patients in 1Q22.Conclusion. Filament Health continues to make progress in developing its naturally-produced botanicals for psychiatric indications. We see the microdosing trial, with its external funding, as a positive step in characterizing the safety, efficacy, and dose response of PEX010. We are reiterating our Outperform rating and price target of $1.50 per share. Read More >>