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Ceruvia Lifesciences Receives FDA Investigational New Drug Approval for Psilocybin Obsessive-Compulsive Disorder Program Phase 2 Trial

Ceruvia Lifesciences Receives FDA Investigational New Drug Approval for Psilocybin Obsessive-Compulsive Disorder Program Phase 2 Trial

GREENWICH, Conn., June 27, 2022 /PRNewswire/ — Ceruvia Lifesciences, a leading neurotransformational medicine biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug application for a Phase 2 clinical trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD). 

“With positive preliminary results from a Ceruvia funded pilot Phase 2 study taking place at Yale School of Medicine, we are excited to have received FDA approval to begin our Phase 2 clinical trial to examine the efficacy and safety of psilocybin in treating OCD,” said Carey Turnbull, Founder and CEO of Ceruvia Lifesciences. “With few effective treatment options available for the almost 4 million Americans who suffer from OCD, our Phase 2 clinical trial is an important step in helping these patients dramatically improve the quality of their lives.”

Ceruvia’s Phase 2, multicenter, randomized, double blind, active placebo controlled clinical trial will examine the safety and efficacy of synthetic psilocybin (SYNP-101) in treating OCD symptoms. The trial plans to enroll a total of 105 participants who will receive 25mg of SYNP-101 or the active placebo, niaicin. The primary endpoint of the trial is to determine the reduction in OCD symptoms for up to 12 weeks after a single administration of SYNP-101. Efficacy of treatment will be measured using the Yale-Brown Obsessive Compulsive Scale, the most used and validated tool for assessing the clinical severity of OCD symptoms. The trial will commence in the second half of 2022 and will be led by Principal Investigators Dr. Benjamin Kelmedi and Dr. Christopher Pittenger of Yale University School of Medicine.

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. Based on 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.

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SOURCE Ceruvia Lifesciences

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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

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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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Yale to study psilocybin for OCD

Ceruvia Lifesciences Submits FDA Investigational New Drug Application for Psilocybin Obsessive-Compulsive Disorder Program

Ceruvia Lifesciences submitted an application to study psilocybin as a treatment for obsessive-compulsive disorder (OCD) in a Phase 2 trial.

Preliminary findings suggest that psilocybin causes a “rapid and robust improvement in OCD symptoms with a sustained effect,” according to the press release.

The trial, which will be led by Yale researchers later this year if approval is granted, will determine if these findings hold true when psilocybin is compared to an active placebo. 

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