Founder-backed investment supports accelerated clinical development through a fully funded Phase 1/2 program
GREENWICH, Conn., Aug. 3, 2026 /PRNewswire/ -- Ceruvia Lifesciences, a leading neurotransformational biopharmaceutical company, today announced an $8 million investment to advance the clinical development of BOL-148, using its proprietary non-hallucinogenic LSD analog for the treatment of cluster headache. The investment fully funds this next stage of clinical development for BOL-148. The company will conduct an integrated Phase 1/2 clinical study designed to efficiently bridge from healthy volunteer dose escalation into proof-of-concept evaluation in patients with cluster headache within a single clinical study.
Part 1 of the study will be a standard Phase 1 single ascending dose evaluation of Ceruvia's drug candidate in healthy adults. Part 2 is designed as a randomized, placebo-controlled Phase 2 study in patients with cluster headache meant to demonstrate the safety and efficacy of BOL-148 in this population, while also exploring dose response and durability of effect.
Ceruvia expects to submit its Clinical Trial Application (CTA) in Germany in September 2026, with first participant enrollment expected in the fourth quarter of 2026. The Phase 1 portion of the study is expected to generate top-line data during the second quarter of 2027 at which time it will progress to the Phase 2 proof-of-concept portion of the study. Results of this trial will support the design and execution of a phase 3 pivotal trial in both the US and EU.
"We've reached an important milestone in the evolution of the BOL-148 program," said Carey Turnbull, Founder and CEO of Ceruvia Lifesciences. "Over the past two years we've refined both the science and the development strategy behind this program. By committing the capital required to complete this integrated Phase 1/2 study, we're now in a position to evaluate both the safety and therapeutic potential of BOL-148 within a single clinical study."
NYPRG-101 (BOL-148) is a proprietary, non-hallucinogenic LSD analog being developed as a potential treatment for cluster headache. The program builds on encouraging preliminary clinical observations reported in a trial conducted by Harvard Medical School in which patients with chronic cluster headache achieved complete and durable response, as well as Ceruvia's own Phase 1 safety experience in healthy volunteers.
Cluster headache is one of the most severe neurological pain disorders, often referred to as the "suicide headache" because of its extreme severity. Current treatment options remain limited, particularly for chronic cluster headache, where there are no FDA-approved preventive therapies. Ceruvia believes NYPRG-101 has the potential to offer a differentiated treatment capable of producing durable remission following a short course of therapy.
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 patients return to living their lives to the fullest.
For more information, please visit www.ceruvialifesciences.com
Media contact:
Chris Koddermann
Tel: +41 (79) 434 25 78
E-mail: chris@cura-communications.com
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