Ceruvia Lifesciences has submitted an FDA Investigational New Drug (IND) Application for its NYPRG-101 Migraine Prevention Program.
The company is aiming to begin a Phase 1 clinical trial of NYPRG-101, which is being developed for the prevention of migraines.
The trial would be a Phase 1, single center, randomised, double blind, placebo controlled, single ascending dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of NYPRG-101 (in healthy adult participants.
NYPRG-101, also referred to in the literature as BOL-148, is a non-hallucinogenic analogue of LSD, differing by only one atom.
First synthesised 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.
Founder and CEO of Ceruvia Lifesciences, Carey Turnbull, commented: “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.
“Migraine, which affects approximately 15 per cent 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 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.
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