MDMA-class trials face an open-label problem no PRO can solve alone. Videra Health is the multimodal observation platform that surfaces vocal, facial, linguistic, and somatic signal across the session and beyond — the objective evidence layer that wins regulatory and payer conversations.
See how we'd observe AydiaSolvonis' MDMA-derivative program for PTSD, positioned to address the regulatory pathway questions Lykos' MDMA-assisted therapy could not.
Aydia is Solvonis' MDMA-derivative program for PTSD. The therapeutic mechanism is established. What's open is regulatory pathway: how to design a trial that delivers the endpoint package the FDA wants and the payer evidence the market demands.
The functional unblinding problem that hit Lykos. The therapist fidelity question the FDA wanted answered. The objective behavioral endpoints traditional PROs cannot deliver. All documented, all addressable in trial design.
The Lykos CRL named specific issues: functional unblinding evidence, therapist conduct documentation, objective behavioral endpoints. Aydia trials can deliver all three from Phase 2 forward — but only if observation is architected in, not retrofitted.
The advantage is real. The execution requires the right measurement stack from day one.
From founding to the post-Lykos opportunity.
MDMA-class trial design challenges are observable problems. Architecting observation into Aydia's trials closes them all.
Patients know they received an entactogen. The fix is not pretending otherwise — it is generating objective behavioral endpoints that survive the unblinding. Videra delivers that layer.
Observable session records make therapist conduct measurable, auditable, and defensible. The FDA cannot ask Aydia's investigators questions Lykos couldn't answer if Solvonis has the recordings.
PTSD recovery happens between visits. Continuous vocal, facial, and linguistic capture surfaces the symptom trajectories driving durability claims and payer access.
Building Aydia's referral funnel starts now. Video-based PTSD screening deployed across primary care surfaces the patient population before commercial launch.
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 Aydia.
A clinical-grade camera and directional audio rig that drops into any Aydia trial site in minutes. Every therapist-participant interaction recorded at the same fidelity, every session reviewable. The defensible record the FDA expects.
Multimodal analysis of voice, video, and language during and after the entactogenic session. The objective behavioral endpoints that survive functional unblinding. The PTSD symptom trajectories between visits.
For Aydia, that means objective response biomarkers, therapist fidelity scoring, and PTSD durability prediction — the exact data set the FDA wanted from Lykos.
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 Phase 2-3 Aydia data, generating objective endpoints, therapist fidelity records, and durability predictions designed for the post-Lykos FDA bar.
Aydia's path to a Lykos-proof Phase 3, 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 Solvonis Therapeutics, that means real clinical depth and peer-reviewed validation.
We'd welcome a 30-minute session to walk Solvonis through a tailored, protocol-by-protocol proposal for Aydia's clinical development plan.