Novamind to Host MindMed Phase IIb Trial for LSD and Anxiety

Rhea-AI Summary

Novamind has been selected by Mind Medicine (NASDAQ:MNMD) to host a phase IIb clinical trial investigating the effects of lysergic acid diethylamide (LSD) on generalized anxiety disorder (GAD) in adults. This historic trial is the first commercial study of LSD in over 40 years, aiming to enroll 200 participants at Novamind's Draper, Utah site.

The trial will explore the efficacy of MM-120, a proprietary form of LSD, over 12 weeks. This collaboration reinforces Novamind's position as a leading provider of psychedelic medicine and clinical trials.

TORONTO, ON / ACCESSWIRE / March 16, 2022 / Novamind Inc. (CSE:NM)(OTCQB:NVMDF)(FSE:HN2) ("Novamind" or the "Company"), a leading mental health company specialized in psychedelic medicine, is pleased to announce it has been selected by Mind Medicine, Inc. (NASDAQ:MNMD), (NEO:MMED) ("MindMed") to host a phase IIb randomized clinical trial investigating lysergic acid diethylamide (LSD) for generalized anxiety disorder (GAD) in adults ("LSD Clinical Trial"). MindMed is a clinical-stage biotech company developing the next generation of psychedelic-inspired medicines and therapies.

The LSD Clinical Trial is the most advanced program in MindMed's clinical drug development pipeline and is the first commercial study of LSD in over 40 years. The primary objective of the study is to determine the reduction in anxiety symptoms for up to twelve weeks after a single administration of MindMed's proprietary drug candidate, MM-120, a pharmacologically optimized form of LSD being developed for GAD and other brain-based disorders. The multi-site LSD Clinical Trial plans to enroll 200 participants with dosing expected later this year.

Novamind will host the LSD Clinical Trial at its Draper, Utah research site, further strengthening its track record of hosting neuropsychiatry and psychedelic clinical trials. In October 2021, Novamind was awarded two DEA Schedule 1 licenses for psilocybin research, qualifying it to conduct a recently announced phase II trial for major depressive disorder sponsored by the Usona Institute, as well as future psilocybin trials. Novamind expects to add LSD under the licenses in relation to the LSD Clinical Trial.

"With anxiety disorders being among the most common mental health conditions, there's a pressing need for new treatment options and, in particular, medications with novel mechanisms of action like LSD," said Dr. Reid Robison, Chief Medical Officer, Novamind. "We're honored to participate in this research study involving such a long-awaited therapy with potential to transform the treatment paradigm in anxiety."

Jamie Freedman, Director of Clinical Operations, MindMed, said: "We're pleased to have finalized our site selection process. Working with companies like Novamind who have experience running clinical research sites for Schedule I substances will be critical to the quality and success of this trial."

Yaron Conforti, CEO and Director, Novamind, commented, "We're excited to host MindMed's historic clinical trial, and to contribute to advancing LSD towards FDA approval. Our team continues to build on Novamind's reputation as an industry leader in clinical research for psychedelic medicine, and we are proud to be a trusted partner for this important work."

The LSD Clinical Trial is expected to move through a series of key milestones over the coming months to prepare for enrollment and patient dosing.

To learn more about Novamind's clinical research division, visit this link.

About Novamind
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.

About MindMed
MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental health and addiction. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed's approach to developing the next generation of psychedelic-inspired medicines and therapies. Visit www.mindmed.co for more information.

Contact Information
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512

Samantha DeLenardo, VP, Communications
Email: media@novamind.ca

Investor Relations
Email: IR@novamind.ca

Forward-Looking Statements
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.

SOURCE: Novamind Inc.

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https://www.accesswire.com/693268/Novamind-to-Host-MindMed-Phase-IIb-Trial-for-LSD-and-Anxiety

FAQ

What is the phase IIb LSD clinical trial hosted by Novamind?

The phase IIb LSD clinical trial, hosted by Novamind, investigates the effects of LSD on generalized anxiety disorder (GAD) in adults, marking the first commercial LSD study in over 40 years.

When does Novamind expect to start dosing participants in the LSD trial?

Dosing in the phase IIb LSD clinical trial is expected to begin later this year, once enrollment is completed.

How many participants will be enrolled in Novamind's LSD clinical trial?

The trial plans to enroll 200 participants to assess the efficacy of MindMed's proprietary drug candidate, MM-120.

What is the primary goal of the phase IIb LSD clinical trial?

The primary objective of the trial is to evaluate the reduction of anxiety symptoms over a period of up to twelve weeks following a single dose of MM-120.

What is Novamind's role in psychedelic medicine?

Novamind is a leading mental health company that specializes in psychedelic medicine, enabling safe access to treatments and conducting clinical research studies.