TORONTO, ON / May 10, 2022 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2)(“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, today announced it has been selected to host a clinical trial for the acute treatment of social anxiety disorder (SAD), an understudied and common mental health condition that affects nearly 15 million American adults.1 The phase II randomized clinical study for the acute treatment of SAD (the “PREVAIL Trial”) is sponsored by Bionomics Limited, a clinical-stage biopharmaceutical company (“Bionomics”) (Nasdaq: BNOX | ASX: BNO) and is currently enrolling patients at Novamind’s Draper, Utah, research site.
The PREVAIL Trial will examine the safety and efficacy of Bionomics’ propriety drug candidate, BNC210, versus a placebo in reducing self-reported anxiety severity when participants take part in an anxiety-provoking behavioral task involving a speaking challenge. People with SAD experience extreme fear in social situations, when meeting new people or speaking in front of others, which can severely and negatively impact relationships, work and daily life. Current medical interventions include SSRIs, beta-blockers and anti-anxiety medications such as benzodiazepines.
Dr. Reid Robison, Chief Medical Officer and Principal Investigator, commented: “Social Anxiety Disorder is an understudied mental health condition and yet it’s very common with widespread impact across multiple domains of life. Existing medications for social anxiety are slow to work or are fraught with adverse effects. It’s exciting to participate in studying a drug with a novel mechanism like BNC210 that could offer patients an alternate treatment option.”
The PREVAIL Trial is the second Bionomics study hosted by Novamind. In 2021, the Company announced it was selected to host a phase IIb randomized clinical trial investigating BNC210 as a treatment for PTSD. BNC210 has Fast Track designations from the U.S. Food and Drug Administration for the treatment of both PTSD and SAD, a process designed to facilitate development and expedite the review of drugs that address an unmet medical need for serious conditions.
Dr. Robison continued, “Working with leading drug developers continues to advance critical mental health research through a variety of compounds and widens the spectrum of conditions under investigation at Novamind’s clinical research sites.”
Novamind is focused on bringing innovative treatments to the world through its clinical research sites and is currently investigating new treatments for PTSD, Tourette’s Syndrome, schizophrenia, treatment-resistant depression, major depressive disorder, traumatic brain injury, bipolar disorder and autism.
To learn more about the PREVAIL Trial, please visit this link.
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of integrative mental health clinics and operates a full-service contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512
Samantha DeLenardo, VP, Communications
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.