Two Phase 3 trials hit their primary endpoint. FDA Rolling Review is open. The Commissioner's National Priority Voucher is awarded. Now the operational lift starts: REMS-ready therapist training, site quality, payer evidence, and patient identification, all at launch scale.
See how we'd partner on COMP360A synthetic, proprietary formulation of psilocybin administered with psychological support. The most advanced psychedelic program in clinical development, with both pivotal Phase 3 trials hitting their primary endpoint for treatment-resistant depression.
COMP005 and COMP006 both met their primary endpoint. COMP006 demonstrated a mean treatment difference of −3.8 points on MADRS at Week 6 for 25 mg vs. 1 mg (p < 0.001), with 39% of 25 mg participants achieving a clinically meaningful (≥25%) MADRS reduction. Onset was statistically significant the day following administration and held through Week 6.
The 6 to 8 hour session with psychological support is COMP360's differentiator and its operational complexity. Therapist consistency, patient experience, and outcome measurement all need to scale beyond hand-picked trial sites into a launch network.
FDA Rolling Review is open. The Commissioner's National Priority Voucher was awarded. NDA submission is targeted for Q4 2026, with 26-week durability data from COMP006 Part B expected in early Q3.
What separates a great Phase 3 from a great launch: REMS-grade site quality, therapist training measurement, payer-grade durability evidence, and patient identification infrastructure. None of that comes from the molecule. All of it comes from operational measurement.
From the first Phase 3 hit to the second, to NDA rolling review and the National Priority Voucher.
COMP360's 6 to 8 hour psilocybin session with psychological support is the program's differentiator. It is also four measurement gaps that standard launch tooling cannot close.
A single COMP360 session generates more clinical signal than a year of weekly MADRS. Vocal affect, facial expression, linguistic content, and patient-therapist interaction all carry information that disappears the moment the session ends. Continuous capture during the session is the only way to preserve it.
Phase 3 had a small group of highly trained therapists. Post-launch, COMP360 will be administered across hundreds of REMS-certified providers with varying training depth and supervision. Without observable session records, therapist consistency becomes a payer talking point and a regulatory exposure.
Spravato's ECHO study set the bar at 6-month durability post-discontinuation. COMP360 needs continuous functional-outcome data, not just MADRS, to win the payer-access fight against Spravato and the long-acting ketamines coming behind it.
Many TRD patients cycle through 3+ antidepressants without ever being flagged as candidates for a referral. Video-based behavioral screening in primary care and community psychiatry can dramatically improve the funnel before 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 COMP360's launch.
A clinical-grade camera and directional audio rig that drops into any COMP360 site in minutes. It captures every therapist and patient interaction across the 6 to 8 hour session with the same framing, angles, and fidelity. Videra's AI watches in real time, flagging protocol or training deviations as they happen.
Our ASSESS platform analyzes voice, video, and language continuously through the COMP360 session and the weeks that follow. It captures within-session shifts that MADRS cannot, and tracks functional durability over the 26-week window payers care about.
We don't stop at data collection. We build condition-specific algorithms on real patient data, with peer-reviewed results. For COMP360, that means a multimodal model that identifies likely responders early, flags relapse risk, and feeds payer dossiers with real-world durability data.
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 3 and post-launch data, combining within-session vocal, facial, and linguistic biomarkers to predict who will respond and who will relapse.
Your priorities for COMP360's NDA and launch, mapped to capabilities Videra already has in production.
Videra's network isn't our customer base. It's the living dataset that powers every algorithm we build. For AbbVie, that means real clinical depth and peer-reviewed validation.
We'd welcome a 30-minute session to walk AbbVie's Neuroscience team through a tailored, protocol-by-protocol proposal for bretisilocin and the broader psychiatry pipeline.