Reset Pharma Receives Notice of Safe to Proceed from FDA for Investigational New Drug (IND) Application for Oral Psilocybin RSTP1000

Company may now initiate Phase 2b trial for treatment of demoralization syndrome in patients with cancer

New York, NY, November 1, 2023 – Reset Pharmaceuticals, Inc. (Reset Pharma), a privately held biotechnology company focused on the development of innovative treatments to address mental health conditions related to life-altering diseases, today announces that the Company has received a Safe to Proceed notification from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application for its oral psilocybin product candidate, RSTP1000, in demoralization syndrome.   

This action by the FDA allows the Company to conduct a Phase 2b trial with RSTP1000 in patients with cancer and demoralization syndrome. The study is a multicenter, randomized, dose-ranging, double-blind, parallel-group study to investigate the preliminary efficacy, safety, and tolerability of a single dose of orally administered RSTP1000 for up to 6 months.

“Our receipt of the Safe to Proceed notification by the FDA is an important step forward in the development of our oral psilocybin product candidate for the treatment of patients with cancer and clinically relevant demoralization,” said Jan-Anders Karlsson, PhD, Interim CEO and Founder of Reset Pharma. “The demoralization for patients diagnosed with cancer can be overwhelming, and the psychological distress can interfere with a patient’s adherence to cancer therapy and the treatment of comorbidities.  Currently there is no approved treatment for demoralization. If ultimately shown to be safe and effective, we believe that RSTP1000 could become a major therapeutic innovation and an important supportive therapy for cancer patients suffering from this debilitating condition.” 

Demoralization syndrome is a significant mental health condition characterized by loss of hope, purpose, and meaning in one’s life. It can occur in patients facing end-of-life progressive diseases such as cancer. It is estimated that 20% or more of all patients with life-altering cancer have clinically relevant demoralization that often occurs independent of other mood disorders like depression or anxiety. These patients have more difficulties with adherence to cancer therapy and are also more likely to have suicidal thoughts. There are currently no effective treatment options for demoralization. Oral psilocybin has shown promise as a novel, innovative treatment of demoralization in patients with cancer.^{1 2 3}
 

About Reset Pharmaceuticals, Inc.

Reset Pharma is a privately held, clinical-stage biotechnology company focused on developing and commercializing novel treatments for patients suffering from mental illness related to life-altering diseases. The Company’s lead product candidate, the oral psilocybin, RSTP1000, is initially being developed to treat Demoralization Syndrome in patients with cancer, as there are currently no effective treatment options for this disorder. Reset Pharma licensed its study drug for the Phase 2b trial from Filament Health Corp., Canada. Reset Pharma has a highly experienced team with a strong track record of successful development, approvals and launches of neuroscience drugs in the US. The Company also has a Scientific Advisory Board of key opinion leaders in psychiatry, oncology and psychedelics, as well as a Strategic Advisory Board of business leaders and financial experts. Information about Reset Pharma can be found at .

Forward-Looking Statements

This press release contains “forward-looking statements” concerning the development and commercialization of Reset Pharmaceuticals’ products, timing of clinical trials, the Company’s business development efforts and its expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements, including the ability to obtain funding to support planned clinical activities. These statements are made as of the date of this press release. Actual results may vary. Reset Pharmaceuticals undertakes no obligation to update any forward-looking statements for any reason.

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Ross S, Bossis A, Guss J, et al. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol. 2016;30(12):1165-1180. doi:10.1177/0269881116675512

Griffiths RR, Johnson MW, Carducci MA, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016;30(12):1181-1197. doi:10.1177/0269881116675513

Grob CS, Danforth AL, Chopra GS, et al. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Arch Gen Psychiatry. 2011;68(1):71-78. doi:10.1001/archgenpsychiatry.2010.116