CaaMTech’s New Clinical Trial Design Solves the Emergent Functional Unblinding Problems Plaguing Psychedelic Medicine Developers
ISSAQUAH, Wash., November 14, 2024 (Ecnetnews.com)
–
CaaMTech, Inc. is pleased to announce positive feedback from United States federal government regulators for its CT-4201 psilocin prodrug program. Amongst other topics, the regulator’s feedback validated CaaMTech’s plan for functional unblinding of its CT-4201 drug trials. This validation clears the clinical development pathway for CT-4201, a psilocin prodrug with improved pharmacokinetics, to be studied for the treatment of Major Depressive Disorder (MDD).
Since 2016, CaaMTech has led the field of serotonin science by designing, synthesizing and characterizing hundreds of novel serotonergic compounds. CaaMTech’s focus on this fundamental scientific work led to the discovery of CT-4201, a novel psilocin prodrug with improved properties compared with psilocybin. Psilocybin, another psilocin prodrug found naturally in “magic mushrooms,” has amassed a growing body of evidence for its lasting effectiveness in treating depression, often from a single dose. Psilocybin has received “Breakthrough Therapy” designation from the FDA for treating depression, but has not been approved by the FDA for the treatment of any medical condition and remains a DEA Schedule I controlled substance.
Recently, psilocybin and other psychedelic medicines have encountered a major hurdle regarding their approval for use as medical treatments: clinical trials conducted to show the safety and efficacy of these drugs have become “functionally unblinded.” “Unblinding” means that clinical trial participants or investigators are able to discern whether a participant has received a placebo or an investigational dose of a drug. This is particularly challenging for psychoactive drugs with distinguishable effects, such as psychedelics.
In August, Lykos Therapeutics’ New Drug Application for its midomafetamine (MDMA)-assisted therapy for post-traumatic stress disorder was rejected by the FDA. Functional unblinding was a major focus of the rejection. In October, COMPASS Pathways announced it was delaying the readout of its phase 3 clinical program of COMP360 psilocybin treatment in TRD, citing “the increased regulatory scrutiny on functional unblinding.” CaaMTech has benefitted from the immense body of work submitted by these pioneers in the field, and the resultant feedback from the FDA, and has successfully incorporated these into its clinical development programs.
“Functional unblinding was a major barrier to the approval of psychedelics as medicines to treat the patients who need them most,” said Dr. Andrew Chadeayne, CaaMTech CEO. “I’m incredibly proud that CaaMTech was able to solve this problem impeding the leading edge of psychedelic drug development.”
About CaaMTech
CaaMTech is a pharmaceutical drug discovery company utilizing a collaborative scientific approach to engineering novel small-molecule therapeutics. We are focused on creating and optimizing next-generation psychedelic-inspired medicines to treat mental health conditions.
Media Contact
Davis Wuolle, CaaMTech
davis@caam.tech
+1.510.747.9001
Source: CaaMTech, Inc.
