Psilera, a biopharmaceutical company developing next-generation mental health treatments for take-home use, announces the selection of their lead clinical candidate, PSIL-006.
PSIL-006 is the first drug candidate from Psilera’s extensive pipeline to progress into advanced safety studies prior to first-in-human clinical trials.
The novel drug with similar characteristics to psilocybin while lacking hallucinogenic effects was derived from Psilera’s in-house discovery pipeline.
When compared directly in preclinical in vivo studies, PSIL-006 was able to induce rapid and positive behavioral changes representative of alcohol use disorder (AUD), anxiety, depression, and cognitive disorders similar to the psilocybin mimic, psilacetin.
In multiple proof-of-concept clinical trials, psilocybin has shown positive efficacy for addiction (AUD and nicotine dependence), depression, and end-of-life anxiety. PSIL-006 represents a non-hallucinogenic alternative to psilocybin.
With fewer side effects, PSIL-006 could enable take-home dosing to greatly enhance treatment scale over psilocybin and other psychedelics.
PSIL-006 is a non-hallucinogenic serotonin receptor 6 (5-HT6) and 2A (5-HT2A) dual agonist that selectively reduces hallucinogenic effects while retaining rapid therapeutic benefits. The unique activity seen in preclinical models represents a novel mechanism of action for addiction and psychiatric disorders.
Dr Chris Witowski, Co-Founder and CEO at Psilera, commented: ”PSIL-006 epitomizes our patient-centric values at Psilera. Our focus is to provide new treatment options to a larger patient population for difficult to treat mental illnesses,” said
“We are enthusiastic by the data with PSIL-006 and look forward to providing further updates as we progress towards the clinic.”
