Greenwich, Connecticut-based Ceruvia Lifesciences announced a USD 8 million founder-backed investment to fully fund an integrated Phase I/II clinical study of BOL-148 (NYPRG-101), its proprietary non-hallucinogenic LSD analog, in patients with cluster headache — a disorder for which no FDA-approved preventive therapies currently exist for the chronic form.
The financing is entirely founder-backed and provides capital sufficient to complete the integrated study without requiring an additional funding round at this stage. No equity dilution terms, warrants, or external institutional investors were disclosed.
BOL-148 is a non-hallucinogenic analog of LSD being developed as a potential short-course therapy capable of producing durable remission in cluster headache. The program builds on preliminary clinical observations from a Harvard Medical School-conducted trial in which patients with chronic cluster headache reported complete and durable responses, as well as Ceruvia's own earlier Phase I safety experience in healthy volunteers.
The integrated study is structured in two parts: a Phase I single ascending dose evaluation in healthy adults followed by a randomized, placebo-controlled Phase II proof-of-concept study in cluster headache patients, designed to assess safety, efficacy, dose response, and durability of effect within a single protocol. Ceruvia said it expects to submit a Clinical Trial Application in Germany in September 2026, with first participant enrollment targeted for Q4 2026. Phase I top-line data are expected in Q2 2027. The company said results from this trial will inform the design of a Phase III pivotal study in both the US and EU.