Ceruvia Raises $8 Million to Advance Non-Hallucinogenic LSD Analog BOL-148 into Integrated Phase 1/2 Trial for Cluster Headache
核心洞察
Ceruvia Lifesciences (搜索) secured $8 million in founder-backed funding to fully finance an integrated Phase 1/2 clinical trial of BOL-148, a proprietary non-hallucinogenic LSD analog for cluster headache (搜索).
The study will combine a Phase 1 single ascending dose evaluation in healthy adults with a randomized, placebo-controlled Phase 2 proof-of-concept trial in cluster headache (搜索) patients.
A Clinical Trial Application is expected to be submitted in Germany by September 2026, with first enrollment anticipated in Q4 2026 and Phase 1 top-line data expected in Q2 2027.
Ceruvia Lifesciences (搜索), a clinical-stage neurotransformational biopharmaceutical company, announced today an $8 million founder-backed investment to advance BOL-148 — its proprietary non-hallucinogenic LSD analog — into an integrated Phase 1/2 clinical trial for the treatment of cluster headache (搜索). The funding fully covers this next stage of clinical development, enabling the company to evaluate both safety and therapeutic potential within a single study design.
The integrated trial will be conducted in two parts. Part 1 is a standard Phase 1 single ascending dose evaluation of the drug candidate in healthy adults. Part 2 is designed as a randomized, placebo-controlled Phase 2 study in patients with cluster headache (搜索), aiming to demonstrate safety and efficacy while also exploring dose response and durability of effect.
"We've reached an important milestone in the evolution of the BOL-148 program," said Carey Turnbull, Founder and CEO of Ceruvia Lifesciences (搜索). "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."
Regulatory and Clinical Timeline
Ceruvia expects to submit its Clinical Trial Application (CTA) in Germany in September 2026, with first participant enrollment anticipated in the fourth quarter of 2026. The Phase 1 portion of the study is projected to generate top-line data during the second quarter of 2027, at which point the program will progress to the Phase 2 proof-of-concept stage. Results from this integrated trial will inform the design and execution of a Phase 3 pivotal trial in both the United States and European Union.
Scientific Rationale and Prior Evidence
NYPRG-101 (BOL-148) builds on encouraging preliminary clinical observations from a trial conducted by Harvard Medical School, in which patients with chronic cluster headache (搜索) achieved complete and durable response. The program is further supported by Ceruvia's own Phase 1 safety experience in healthy volunteers. By engineering a non-hallucinogenic analog of LSD, Ceruvia aims to retain the therapeutic benefits observed with serotonergic compounds while eliminating the psychedelic effects that complicate clinical use.
Unmet Medical Need in Cluster Headache (搜索)
Cluster headache (搜索) is among the most severe neurological pain disorders, often referred to as "suicide headache" due to its extreme intensity. Current treatment options remain limited, particularly for the chronic form of the condition, for which 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.
Founded in 2017 by Carey Turnbull, Ceruvia Lifesciences (搜索) maintains longstanding research partnerships with leading institutions including Yale University School of Medicine, NYU School of Medicine, and Harvard Medical School. The company's pipeline extends beyond cluster headache (搜索) to include programs targeting obsessive-compulsive disorder and substance abuse disorder.