The article Ceruvia Lifesciences Submits Phase 1 Trial Application With the FDA was originally published on Microdose.
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
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