Mindset Pharma Progresses Plans for Clinical Trials of its Advanced Pre-Clinical Psychedelic, MSP-1014
Mindset Pharma (OTCQB: MSSTF) is progressing its lead clinical candidate MSP-1014 towards human trials, following successful preclinical results. The company has appointed Clerkenwell Health as its Contract Research Organization to prepare for initial discussions with UK regulators. MSP-1014 shows improved efficacy and safety compared to psilocybin, targeting mood and substance misuse disorders. Manufacturing of pharmaceutical-grade MSP-1014 is underway, aiming for IND-enabling studies and clinical trials in 2023.
- Progressing MSP-1014 towards clinical trials.
- Engaged Clerkenwell Health for regulatory discussions.
- Improved efficacy and safety profile of MSP-1014 versus psilocybin.
- Manufacturing of 1kg of pharmaceutical-grade MSP-1014 underway.
- None.
TORONTO, May 12, 2022 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company"), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that it is making headway in progressing its Family 1 lead clinical candidate, MSP-1014, towards clinical trials. Recently, the Company engaged a UK-based Contract Research Organization (CRO), Clerkenwell Health, to prepare for an initial scientific meeting with regulators to discuss the company’s initial plans for clinical development.
“At Mindset, we are working diligently to advance MSP-1014 through the regulatory process as quickly as possible. We have selected an expert CRO, Clerkenwell Health, to lead the initial scientific discussions with the regulators in the UK as we start to pull together our clinical plans. We’re invigorated by this next step and look forward to providing updates along the way,” said James Lanthier, CEO of Mindset.
MSP-1014, Mindset’s Family 1 lead candidate, in preclinical studies demonstrated an improved efficacy, with reduced potential side effects, and safety profile compared to first-generation drug candidate psilocybin. Given its improved pharmacological profile in preclinical models, Mindset has prioritized moving MSP-1014 to first in human (FIH) studies to confirm human safety, pharmacokinetic profiles and the effective human dose range. If MSP-1014 data translates, Mindset will have one of the first novel psychedelic drugs in human clinical trials with the potential to treat mood disorders, including major depressive disorder, substance misuse disorders and end-of-life angst associated with terminal illnesses, including cancer. The Company is in the process of manufacturing 1kg of pharmaceutical grade product to move into IND-enabling studies and subsequent human clinical trials as early as 2023.
Joseph Araujo, Chief Scientific Officer at Mindset, confirmed, “In a side-by-side comparison, our extensive preclinical data shows there is clear differentiation from psilocybin. We are excited to move this drug candidate forward as quickly as possible to human trials to confirm that this data translates into meaningful benefits for patients who are waiting for new medicines.”
Mindset continues to perform studies across various preclinical models with MSP-1014, from its Family 1, and its library of next-generation psychedelic compounds to show the differentiation of their novel drug candidates and to build a catalog of translational data as they prepare for human clinical trials. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. The Company is working with Otsuka’s McQuade Center for Strategic Research and Development on its Families 2 & 4.
About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin in addition to its own proprietary compounds. The company has a co-development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-duration compounds, Mindset Families 2 & 4.
For further information on Mindset, please visit our website at www.mindsetpharma.com.
For more information, please contact:
Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267/ 347-487-6788
Media Contact:
McKenna Miller
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 949-606-6585
Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com
Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094
Forward-Looking Information
This news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate", "may", "will", "would", "potential", "proposed" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company's business are contained under the heading "Risk Factors" in the Company's annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.
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