Ceruvia Lifesciences Submits FDA Investigational New Drug Application for NYPRG-101 Migraine Prevention Program

Ceruvia Lifesciences Submits FDA Investigational New Drug Application for NYPRG-101 Migraine Prevention Program

  • Based on a positive pre-IND meeting with the U.S. Food and Drug Administration (FDA), Ceruvia Lifesciences has submitted an Investigational New Drug (IND) application to begin a Phase 1 clinical trial of NYPRG-101, a non-hallucinogenic analog of Lysergic acid diethylamide (LSD), being developed for the prevention of migraine.

GREENWICH, Conn., June 21, 2022 /PRNewswire/ — Ceruvia Lifesciences, a leading neurotransformational medicine biopharmaceutical company today announced the submission of an IND application to begin a Phase 1, single center, randomized, double blind, placebo controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NYPRG-101 (2-bromo-D-lysergic acid diethylamide) in healthy adult participants. 

NYPRG-101, also referred to in the literature as BOL-148, is a non-hallucinogenic analog of LSD, differing by only one atom. First synthesized at Sandoz by Albert Hofmann in 1957, BOL-148 was used as a placebo in early LSD trials.  BOL-148 has been administered to more than 150 humans (126 healthy volunteers and 28 patients) in clinical and experimental settings since the 1950s, with most of the research occurring prior to 1970.  In these early studies, BOL-148 was observed to be non-hallucinogenic.

“This is another exciting milestone in the roll-out of our clinical drug development program and builds on our longstanding relationship with Harvard Medical School to investigate the use of BOL-148 to treat headache disorders”, said Carey Turnbull, Founder and CEO of Ceruvia Lifesciences.  “Migraine, which affects approximately 15% of the population and disproportionately impacts women, is associated with significant psychosocial burden and disability.   Results from our IND-enabling pre-clinical toxicology work as well as research conducted with human subjects prior to the 1970s, indicate a positive safety profile for NYPRG-101.  We believe that this molecule has great potential to provide meaningful relief to those suffering from migraine.”

This Phase 1 single ascending dose (SAD) trial, to be held at a single clinical research site in the United States, will evaluate the safety, tolerability, pharmacokinetics and effects on neurocognitive functioning of healthy adult participants. 

About Ceruvia Lifesciences

Founded in 2017, Ceruvia Lifesciences is a clinical-stage biopharmaceutical company with a mission to improve the lives of underserved patients suffering from neurological and psychiatric disorders.  Founded by Carey Turnbull, Ceruvia is relentlessly focused on the development and commercialization of neurotransformational medicines to deliver meaningful relief to patients suffering from hard-to-treat headache disorders, OCD and substance abuse disorder.  For too long, these communities have been poorly understood and under-served. At Ceruvia, we believe they no longer have to live this way.  With a long history of partnership with leading researchers at Yale University School of Medicine, NYU School of Medicine and Harvard Medical School, Ceruvia is undertaking clinical research in order to help them return to living their lives to the fullest. For more information, please visit www.ceruvialifesciences.com

SOURCE Ceruvia Lifesciences

Free LSD!

Ceruvia Lifesciences to Supply LSD to Qualified Researchers at No Cost

For qualified researchers only… sorry to get your hopes up.

Ceruvia Lifesciences, a private Connecticut-based company, produced the world’s first LSD that meets the FDA’s strict manufacturing standards.

Now, the company is offering the drug to researchers at no cost to increase our knowledge of its potential medical benefits.

Ceruvia has also developed a non-hallucinogenic analog of LSD to target cluster headaches, migraines, and addiction.

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24 hour trip anyone?

MINDCURE Achieves Key Development Milestone for Novel Ibogaine Program

Tripping on ibogaine can last over 24 hours, and it’s not always pleasant. But the wide range of benefits could make it worthwhile. 

MINDCURE (MCUR) hopes so at least. The company filed a provisional patent for synthetic ibogaine mixtures to treat various central nervous system disorders like:

  • Addiction
  • Traumatic brain injury
  • Anxiety disorders
  • Chronic pain such as migraines and cluster headaches

The company aims to be a global supplier of synthetic ibogaine for research purposes and expects to have supply available by the end of Q2 this year.

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Wesana Completes Filing of PCT Patents for Novel Drug Protocols

Wesana Completes Filing of PCT Patents for Novel Drug Protocols

CHICAGO and TORONTO, Dec. 09, 2021 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc.  (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company, is pleased to announce that it has filed Patent Cooperation Treaty (“PCT”) patent applications towards securing the exclusive rights to protocols, delivery methods and compositions of matter which includes utilizing a high loading dose of psilocybin-assisted psychotherapy, coupled with non-hallucinogenic, low maintenance doses of psilocybin with and without other evidence-based therapies (plant medicines, fungi and adaptogens) to treat neurological based conditions.

This PCT application, filed with the World Intellectual Property Organization will enable Wesana to file patent applications and seek protection in most major markets throughout the world.

These applications are focused on developing novel therapies to treat symptoms associated with traumatic brain injury (“TBI”), such as depression and anxiety, as well as migraines unrelated to TBI among the general population. Overall, any patent efforts in relation to the foregoing are at the patent application stage.

“Since we began our research at Wesana, our goal remains to find novel therapies to help other sufferers of TBI and mental health challenges find hope through effective healing medicine and therapies,” said Daniel Carcillo, Wesana founder and CEO. “As we continue to develop our process and refine our unique solutions, we want to ensure proper IP protection to be able to provide the most innovative methods for proper treatment. To pass this critical milestone and bring us one step closer to accomplishing this goal is truly thrilling.”

Dr. Mark Wingertzahn, Wesana’s Chief Scientific Officer, added “I am excited for this filing as it serves to further advance Wesana’s proprietary development portfolio.”

About Wesana Health

Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.

Cautionary Note Regarding Forward-Looking Information

This press release includes statements or information which may constitute “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to, statements with respect to activities, events or developments that the Company expect or anticipate will or may occur in the future, including management’s assessment of future plans, operations and performance and statements with respect to the business plan of the Corporation. In certain cases, forward-looking statements can be identified by terminology such as “may”, “will”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “estimate”, “predict”, “forecast”, “outlook”, “potential”, “continue”, “should”, “likely”, or the negative of these terms or other comparable terminology. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.

Any patent efforts of the Company remain at the application stage and there is no assurance that the Company will file additional patent applications or in what jurisdictions they may be filed, if any. Furthermore, while the PCT application has been filed, there is no assurance that a patent(s) will be granted or will be granted in a form that will be sufficient to protect the Company’s proprietary therapies or protocols or enable it to gain or keep any competitive advantage that it may have.

Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to the ability of the Company to protect its intellectual property, changes to patent law, requirements to share intellectual property with service providers, general economic, market and business conditions and other risk factors including those found in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.

Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.

For more information, please contact:

Investor Contact:
Keenan Gentry
Email: IR@wesanahealth.com 
Phone: 773-236-7972

Media Contacts:
Nick Opich / Fallon Carter
KCSA Strategic Communications 
Email: Wesana@kcsa.com 
Phone: 212-896-1206

On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: 773-236-7972

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Source: Wesana Health

Released December 9, 2021

Curing ‘suicide headaches’ with 3 doses of shrooms

Psychedelics Could Be a Medical Game-Changer—So I Tried Them for My Debilitating Headaches

Inspired by recent research on psychedelics, a journalist resorted to shrooms to ease her debilitating cluster headaches (which are often called “suicide headaches” because they’re supposedly more painful than childbirth, gunshot wounds, and kidney stones). She finally found relief that common migraine medications couldn’t provide her after taking 3 small doses of magic mushroom tea, 5 days apart. “Two months have now passed without my having a single headache.” A Yale neurologist explains that the chemical structure of psilocybin is similar to melatonin and triptans, which are often used to treat headaches, but the effect is longer-lasting.