BOL-148 is your commercial wedge and your regulatory challenge at once. Proving 5-HT2A efficacy without the psychedelic experience requires endpoint quality the standard PRO stack wasn't designed to deliver. Videra captures the mechanism-of-action signal without confounding it with subjective psychedelic effects.
See how we'd observe NYPRG-101Ceruvia Lifesciences' brominated LSD analog program — non-hallucinogenic 5-HT2A modulation targeting cluster headache and adjacent indications.
NYPRG-101 is Ceruvia's BOL-148 program — a brominated LSD analog that retains 5-HT2A activity without producing a psychedelic experience. The therapeutic potential extends across cluster headache and adjacent 5-HT2A indications.
The commercial wedge is real: a 5-HT2A therapy you can prescribe and dispense like any other small molecule. No REMS, no monitored sessions, no scheduling burden. But the regulatory case requires proving efficacy in a way standard PROs weren't designed to capture.
Behavioral biomarkers can isolate the 5-HT2A mechanism-of-action signal without confounding it with subjective psychedelic effects. Vocal, facial, and somatic signal can demonstrate efficacy in ways MADRS at Day 28 cannot — because the mechanism is the entire story.
The 'efficacy without trip' narrative needs an evidence stack engineered for that exact claim.
Tracking the non-hallucinogenic 5-HT2A space.
Four observation gaps separate 'non-hallucinogenic 5-HT2A' from 'commercially viable therapy.'
When you remove the psychedelic experience, you remove part of what standard PROs measure. Behavioral biomarkers can isolate the underlying mechanism signal independent of perceived subjective effects.
Continuous voice and video monitoring across attack and remission periods generates the high-resolution data that makes the efficacy case to FDA and the value case to payers.
Behavioral observation in cluster headache trials surfaces mechanism signal that informs expansion into adjacent 5-HT2A indications — depression, anxiety, OCD, addiction.
The FDA and payers need confidence that NYPRG-101 truly lacks psychedelic effects. Multimodal behavioral observation provides the objective evidence layer.
Our platform pairs in-clinic AI hardware with multimodal behavioral analytics and a custom algorithm engine, already proven in TDScreen and Check on Mom. Here's how each maps to NYPRG-101.
A clinical-grade camera and directional audio rig that drops into any NYPRG-101 trial site in minutes. Every clinician-participant interaction captured at the same fidelity — the baseline for mechanism observation independent of psychedelic confound.
Multimodal analysis of voice, video, and language during and between cluster headache attacks. The objective measurement layer that proves efficacy without depending on subjective psychedelic effects.
For NYPRG-101, that means a proprietary non-psychedelic 5-HT2A response signature — distinguishing therapeutic effect from subjective experience in a way standard endpoints cannot.
AI-powered tardive dyskinesia screening built on the AIMS standard. AUC 0.89 vs. trained raters, peer-reviewed in J Clin Psychiatry.
Conversational AI + video screener for postpartum depression. Used in real homes, on real devices, validated against clinical frameworks.
Multimodal AI model trained on NYPRG-101 cluster headache data, isolating the 5-HT2A mechanism signal from subjective experience confounds.
Your non-hallucinogenic 5-HT2A strategy, mapped to Videra capabilities in production.
Videra's network isn't our customer base. It's the living dataset that powers every algorithm we build. For Ceruvia Lifesciences, that means real clinical depth and peer-reviewed validation.
We'd welcome a 30-minute session to walk Ceruvia Lifesciences through a tailored, protocol-by-protocol proposal for NYPRG-101's cluster headache program.