Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that the Company has received Scientific Advice from the UK Medicines and Healthcare products Regulatory Agency ("MHRA") on a range of points to finalize its Phase 1 first-in-human clinical trial plan evaluating its lead psychedelic drug candidate MSP-1014 for the treatment of Major Depressive Disorders (MDD) .

In a meeting with the MHRA, Mindset discussed its plans for Phase 1 first-in-human clinical development of MSP-1014, a novel and patented, second-generation psilocybin-like drug candidate within Family 1, in collaboration with a specialized psychedelic UK-based Contract Research Organization (CRO), Clerkenwell Health. The MHRA has agreed with the Company's position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time. The MHRA has also provided specific valuable guidance on potential clinical trial design regarding dosing, patient selection criteria, and safety endpoints.

In preclinical studies, MSP-1014, demonstrated an improved efficacy and safety profiles, with reduced potential side effects and faster onset of action, and similar duration of effect compared to the first-generation drug candidate psilocybin. Given its differentiation and improved pharmacological profile, Mindset prioritized moving MSP-1014 to first-in-human clinical studies.

"We are thrilled to have received this favorable written guidance from the MHRA, confirming the readiness of MSP-1014 for Phase 1 first-in-human clinical development. We have been working diligently to advance MSP-1014 through the regulatory process and with this guidance, we have taken yet another essential step toward clinical trials and will not be required to conduct additional preclinical safety studies at this time, which removes costly and time consuming steps," said James Lanthier, CEO of Mindset Pharma. "Moving our lead drug candidate forward to human trials will contribute to Mindset's goal of reaching patients suffering with mental health conditions who are waiting for new medicines with meaningful benefits."

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
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267

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.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.



Primary Logo

News Provided by GlobeNewswire via QuoteMedia

MSET:CNX
The Conversation (0)
Mindset Pharma to Participate in Upcoming Conferences in December 2022

Mindset Pharma to Participate in Upcoming Conferences in December 2022

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that James Lanthier, CEO of Mindset, and Joseph Araujo, CSO, will participate in two upcoming conferences:

  • Stifel GMP's The Future of Healthcare Conference to be held virtually on Wednesday, December 7, 2022. Mr. Lanthier and Mr. Araujo will participate in a fireside chat with Andrew Partheniou, Stifel Research Analyst, at 3:30 p.m. ET.

  • Canaccord Genuity Symposium on New Paradigms and Treatment Approaches in Mental Health to be held virtually on Tuesday, December 13, 2022. Mr. Lanthier and Mr. Araujo will present at 11:00 a.m. ET.

For more information about the conferences, or to schedule a one-on-one meeting with Mindset management, please contact your appropriate representative directly, or send an email to KCSA Strategic Communications at Mindset@kcsa.com .

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Mindset Pharma CEO, James Lanthier Issues Letter to Shareholders

Mindset Pharma CEO, James Lanthier Issues Letter to Shareholders

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") today issued a letter to shareholders from James Lanthier, Chief Executive Officer of Mindset.

Dear Fellow Shareholders:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Mindset Pharma and PharmAla Enter into Exclusive Sales Agreement for the Sale and Distribution of Pharmaceutical Grade Psilocybin

Mindset Pharma and PharmAla Enter into Exclusive Sales Agreement for the Sale and Distribution of Pharmaceutical Grade Psilocybin

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, and PharmAla Biotech Holdings Inc. ("PharmAla")(CSE: MDMA) a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, today announced that they have entered into an exclusive sales agreement. Under the sales agreement, PharmAla will be the exclusive global reseller of Mindset's cGMP (i.e. pharmaceutical grade) psilocybin to appropriately licensed clinical researchers.

"In addition to forging new ground in next generation psychedelic drug discovery, Mindset has also developed a patent-pending, highly scalable psilocybin synthesis technology. A cost-effective supply of first generation psychedelic therapeutics is essential to the overall development of the medical psychedelic space, and Mindset is eager to help meet this increased demand for pharmaceutical grade psilocybin from researchers," said James Lanthier, CEO of Mindset. "We have chosen PharmAla as a partner because of their track record in working with clinical researchers, and existing sales infrastructure to sell pharmaceutical grade psychedelic compounds. It's also yet another concrete example of Mindset commercializing and creating value from its portfolio of innovations."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Mindset Pharma and PharmAla Biotech Enter into Exclusive Sales Agreement

Mindset Pharma and PharmAla Biotech Enter into Exclusive Sales Agreement

PharmAla Biotech Holdings Inc. ("PharmAla")(CSE: MDMA), a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, and Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset"), a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that they have entered into an exclusive sales agreement. Under the sales agreement, PharmAla will be the exclusive global reseller of Mindset's cGMP (i.e. pharmaceutical grade) psilocybin to appropriately licensed clinical researchers.

"In addition to forging new ground in next generation psychedelic drug discovery, Mindset has also developed a patent-pending, highly scalable psilocybin synthesis technology. A cost-effective supply of first generation psychedelic therapeutics is essential to the overall development of the medical psychedelic space, and Mindset is eager to help meet this increased demand for pharmaceutical grade psilocybin from researchers," said James Lanthier, CEO of Mindset. "We have chosen PharmAla as a partner because of their track record in working with clinical researchers, and existing sales infrastructure to sell pharmaceutical grade psychedelic compounds. It's also yet another concrete example of Mindset commercializing and creating value from its portfolio of innovations."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Mindset Pharma Presents Poster at Neuroscience 2022 Highlighting Preclinical Data on MSP-1014, its Psilocybin-like Lead Drug Candidate

Mindset Pharma Presents Poster at Neuroscience 2022 Highlighting Preclinical Data on MSP-1014, its Psilocybin-like Lead Drug Candidate

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced data from preclinical studies comparing its novel prodrug of psilocin, MSP-1014, side-by-side to psilocybin across a battery of studies evaluating safety, behavioral and pharmacokinetics properties of both psilocin prodrugs. Joseph Araujo, Chief Scientific Officer, Director of Mindset Pharma, presented the findings at Neuroscience 2022 hosted by the Society of Neuroscience (SfN) in a poster titled " The Preclinical Safety, Behavioural and Pharmacokinetics Properties of MSP-1014, a Novel Prodrug of Psilocin ."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
ASX:HIQ

HITIQ Announces Exclusive Global Agreement with Shock Doctor for PROTEQT Instrumented Mouthguard

Common Shareholder Questions – Entitlement Offer

HITIQ Limited (ASX: HIQ) (HITIQ or the Company), a pioneer in concussion management, proudly announces an exclusive global agreement with Shock Doctor, the world’s leading mouthguard innovator. This landmark agreement marks Shock Doctor’s two-year effort to design a mouthguard that will integrate HITIQ’s PROTEQT technology. The result is a fully developed, market-ready solution that merges HITIQ’s smart sensor technology with Shock Doctor’s unmatched global production partner capabilities.

Keep reading...Show less
U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET®  as First and Only Treatment for People with Acute Hepatitis C Virus

U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® as First and Only Treatment for People with Acute Hepatitis C Virus

  • MAVYRET ® (glecaprevir/pibrentasvir) is the first and only oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV)*
  • With this approval, providers can now treat HCV patients immediately at the time of diagnosis
  • HCV is a curable condition, but patients can often go undiagnosed. 1 If left untreated, people with acute HCV   could progress to chronic disease, including liver-related complications, such as cirrhosis or liver cancer 1
  • The approval supports global clinical guidelines to advance testing and treatment for people with HCV regardless of chronicity, and supports public health goals for disease elimination

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET ® (glecaprevirpibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, MAVYRET is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. 2,†

HCV is a highly infectious blood-borne disease affecting the liver. 1 People recently infected, or those with acute HCV, may not have symptoms. 1 If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer. 1 The United States is expected to incur ~$120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV. 3

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
HeartSciences Inc

HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis

Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems

Keep reading...Show less
AbbVie Invites People Living with Migraine to Enter the Second Annual AbbVie Migraine Career Catalyst Award Contest to Support Their Professional Goals

AbbVie Invites People Living with Migraine to Enter the Second Annual AbbVie Migraine Career Catalyst Award Contest to Support Their Professional Goals

  • The AbbVie Migraine Career Catalyst Award™ contest is now open for entries, offering financial support to help winners pursue career and professional development goals.
  • As the only company with three approved products designed to meet patient needs across the spectrum of migraine, AbbVie is   committed to supporting the migraine community beyond treatment.
  • Migraine affects productivity and career growth—up to 90% of people with migraine report it interferes with their ability to function at work, highlighting the need for meaningful support beyond treatment.

- AbbVie (NYSE: ABBV) today announced the second annual AbbVie Migraine Career Catalyst Award ™ contest is now accepting entries. AbbVie is proud to continue this nationwide initiative supporting people living with migraine by awarding 20 entrants with $2,500 each that they may use to pursue their personal, professional, and educational goals.

"Migraine can be an invisible barrier to success in the workplace where the condition is often misunderstood or stigmatized," said Carl Cincinnato , executive director, Migraine at Work, a nonprofit initiative under the World Health Education Foundation dedicated to improving workplace environments for individuals living with migraine. "Initiatives like the AbbVie Migraine Career Catalyst Award™ contest not only provide financial support but also serve as a powerful form of advocacy for people living with migraine."

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
AbbVie to Present at the Goldman Sachs 46th Annual Global Healthcare Conference

AbbVie to Present at the Goldman Sachs 46th Annual Global Healthcare Conference

AbbVie (NYSE: ABBV) will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on Tuesday, June 10, 2025 . Management will participate in a fireside chat at 10:20 a.m. Central time .

A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the session will be available later that day.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
AbbVie Partners with Chicago Cubs on "Striking Out Cancer"

AbbVie Partners with Chicago Cubs on "Striking Out Cancer"

Chicago -based institutions aim to create greater awareness for cancer advocacy and to support non-profit cancer organizations

AbbVie (NYSE: ABBV) announced a multi-year partnership with the Chicago Cubs to support people living with cancer through a campaign called "Striking Out Cancer" which starts today when the Chicago Cubs play the Cincinnati Reds. As part of the first year of the partnership, AbbVie will make a $233 donation for every strikeout by a Chicago Cubs pitcher at home during the 2025 regular season. The donation amount is in honor of the approximately 233 Americans diagnosed with cancer every hour, according to the American Cancer Society. 1

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×