IQI - Incannex preparing psilocybin therapy FDA IND application
(NewsDirect)
Incannex HealthcareLtd (ASX:IHL, NASDAQ:IXHL) chief medical officer Dr Mark Bleakleytells Proactive the company is preparing an application to gain keyregulatory approval to begin clinical trials in the US for itspsilocybin-assisted psychotherapy development program (Psi-GAD).PsiGAD is a unique and proprietary form of therapy to treat patientswith generalised anxiety disorder (GAD). Interim analysis for thePhase 2 Psi-GAD clinical trial in March at Monash University predicteda greater than 85% chance of the trial showing statisticallysignificant benefit for the psilocybin treatment arm versus theplacebo arm. Work on the draft IND application comes ahead of finalresults from the Psi-GAD clinical trial, which are expected in Q4 2023or Q1 2024.
Incannex CEO and managing director Joel Latham said of theapplication, “Commencing IND preparation demonstrates our confidencein the utility of the Psi-GAD therapy.
"The interim analysis and the progressmade by Dr Liknaitsky and his team at Monash University has empoweredus to fast-track various strategic business decisions to hasten thedevelopment of the therapy.
"Our organisation is consistently fortifyingits position as a frontrunner within the psychedelic research sectorand we eagerly anticipate the results from our Phase 2 trial upon itscompletion.”
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Proactive Investors
JonathanJackson
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