Psilera Confirms PSIL-002, A New DMT Derivative, is Well-Tolerated and Non-Hallucinogenic from In Vivo Behavioral Studies

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The first of a series of new compounds at Psilera is confirmed as non-hallucinogenic at greater than ten times the dosing of N,N-dimethyltryptamine (DMT) with further biological and behavioral assessments in progress

This biological data is key to our vision of reducing side effects such as hallucinations while further optimizing classical psychedelics into next-generation drugs

Psilera Inc. (“Psilera”), a Florida-based biotechnology company developing non-hallucinogenic derivatives of psychedelic compounds and outpatient delivery methods for the treatment of anxiety, substance abuse, and PTSD, is thrilled to receive positive results from in vivo preclinical studies. A modified DMT derivative, PSIL-002, was safe, well-tolerated, and without hallucinogenic effects at all administered dosages between 0.5 to 100 mg/kg in mice.

The head-twitch-response (“HTR”) assay in mice is a well-established and preferred method of assessing hallucinogenic effects in animals. Astonishingly, no dose of PSIL-002 induced the HTR as compared to the positive control, psilacetin (“4-AcO-DMT”), a psilocybin mimic. Other psychedelics like psilocybin and DMT often produce the HTR at doses from 1-10 mg/kg or as low as 0.05-0.1 mg/kg for LSD, further demonstrating the non-hallucinogenic potential of PSIL-002 and broader range for therapeutic dosing.

Psilera’s patent-pending new chemical entity (“NCE”) library was designed to maintain the positive mood benefits of current psychedelics while reducing hallucinations and cardiotoxicity. Psilera has carefully selected their NCEs aided by its proprietary BRAIN technology platform which virtually screens and filters compounds for psychedelic potential at multiple receptors, especially 5-HT2A. Reducing the hallucinogenic effects represent a compelling opportunity to develop therapeutic drugs which can be administered outside of a clinical setting, expanding the total addressable market.

“This biological data is key to our vision of reducing side effects such as hallucinations while further optimizing classical psychedelics into next-generation drugs,” said Dr. Chris Witowski, Co-Founder and CEO of Psilera, Inc. “Compounds like PSIL-002 have the potential to reach new patient populations in need with greater access than current models, especially for those suffering from conditions where hallucinations may be undesirable. We’re delighted to validate the results from our BRAIN platform and look forward to further data readouts to bolster our dataset and intellectual property strategy.”

Further in vivo studies with PSIL-002 will assess the antidepressant, anxiolytic, and anti-addictive properties specifically targeting alcohol consumption. A compound shown to reduce substance abuse, 4-AcO-DMT,1 as well as five additional patent-pending NCEs will be screened in the same battery of translational behavioral assays with data readouts over the next several months.

About Psilera - Psilera Inc. is a psychedelic-based biotechnology company developing its proprietary neuromodulator pipeline to target mental health disorders. With a proven and award-winning executive team, Psilera leverages research strengths from the pharmaceutical and cannabis industries to repurpose psychoactive natural products into patient-centric treatments. New formulations tailoring the therapeutic effects of DMT will improve treatment scalability and patient compliance further expanding addressable markets. Psilera's technology platform (BRAIN) will identify next-generation compounds with modified psychedelic and therapeutic effects in the areas of mood, cognitive, and substance use disorders.

1Vargas-Perez, Hector, et al. “A Single Administration of the Hallucinogen, 4-Acetoxy-Dimethyltryptamine, Prevents the Shift to a Drug-Dependent State and the Expression of Withdrawal Aversions in Rodents.” European Journal of Neuroscience. 45, 11, 2017, doi:10.1111/ejn.13572.

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Colin Trethewey
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