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Psilera Initiates Landmark Preclinical Studies with New Psychedelic Derivatives aimed at Reducing Alcohol Consumption

Psilera Inc. (“Psilera”), a Florida-based biotechnology company specializing in the clinical development of psychedelics and analogues, is thrilled to begin preclinical studies with its novel drug candidates aimed to reduce alcohol consumption. Alcohol use disorder (AUD) is a growing addiction that affects 283 million people worldwide and 5.3% of all deaths are alcohol related¹; fewer than 10% affected with AUD seek treatment in developed countries.²

This ground-breaking study will be the first in vivo screening of these psychedelic-inspired new chemical entities (NCEs) and will be performed by Dr. Danielle Gulick’s laboratory at the USF Health Neuroscience Institute at the University of South Florida. Dr. Gulick’s lab specializes in addiction, especially alcoholism, and its effects on aging and neuropsychiatric disorders. Psilera will provide up to seven NCEs which will be analyzed to assess efficacy in AUD and psychedelic effects via established preclinical models.

“The growing prevalence of alcohol use disorder, especially in conjunction with the Covid-19 pandemic, needs to be addressed as the current methods of treatment are outdated and insufficient,” said Dr. Jackie von Salm, Co-Founder and CSO of Psilera Inc. “We consider this yet another important step towards our understanding of psychedelic and psychedelic-inspired compounds, and their potential as future medicines in the field of addiction. This in vivo research will provide crucial biological feedback which will further validate our computational efforts with BRAIN to expand towards optimized, next-generation psychedelic treatments.”

In addition to Psilera’s NCEs, the psilocybin compound mimic psilacetin (“4-AcO-DMT”) will be used as a psychoactivity reference and determine its effects on alcohol consumption. Previous preclinical results have shown that 4-AcO-DMT produces effects analogous to psychedelics in humans, while also reducing opioid and nicotine dependences.³ Psilera will be using 4-AcO-DMT, provided by the Usona Institute’s Investigational & Material Drug Supply Program, to compare with its patent-pending NCEs to determine psychedelic effects or lack thereof and anti-addiction potential.

Psilera has carefully selected their NCEs aided by its proprietary BRAIN dataset for virtual screening and to filter compounds for psychedelic potential at the serotonin 5-HT2A receptor. Reduced activity at this receptor would represent a compelling opportunity to develop therapeutic drugs with limited psychedelic effects and the potential to be administered outside of a clinical setting. These next-generation psychedelic-derived medicines could reach new patient populations in need with greater access.

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.

¹Global Status Report on Alcohol and Health 2018. Geneva, Switzerland: WHO Press, 2018.

²Kranzler, H. R. and Soyka, M. (2018). Diagnosis and Pharmacotherapy of Alcohol Use Disorder. Journal of the American Medical Association, 320(8), 815-824.

³Vargas-Perez, H. et al. (2017). 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), 1410–1417.