ALA-3000 is the first ketamine formulation to deliver sustained plasma exposure for over a week without dissociation, sedation, or psychosis. That is the asset, the commercial wedge, and the proof point you need to nail before Phase 2.
See how we'd partner on ALA-3000A long-acting, sustained-release subcutaneous ketamine injection: the first ketamine formulation engineered to deliver more than a week of plasma exposure from a single dose, with no dissociation, no sedation, and no psychosis observed in Phase 1.
ALA-3000 is the first ketamine formulation to deliver sustained plasma exposure beyond a week from a single subcutaneous dose. Pharmacokinetics show plasma ketamine rising gradually, without the pronounced peaks of immediate-release formulations that drive dissociation and require in-clinic monitoring.
Phase 1 was randomized, double-blind, placebo-controlled. ALA-3000 plus oral antidepressant produced MADRS reductions as early as 24 hours, sustained from day 9 through day 36, with a 3 to 6 point advantage over placebo at 150 mg.
No dissociation. No sedation. No psychosis-like symptoms. If that profile holds in Phase 2, ALA-3000 reshapes the entire ketamine therapy market by eliminating the in-clinic monitoring requirement that gates Spravato's reach. The commercial wedge against Spravato is real. The proof point lives in objective behavioral measurement.
Self-reported absence of dissociation is necessary but not sufficient. The reduced-monitoring claim needs objective vocal, facial, and behavioral biomarkers to survive payer review, regulatory scrutiny, and competitive comparison.
From first patient dosing to the Phase 1 readout that broke the 1-week barrier.
The reduced-monitoring profile that makes ALA-3000 commercially viable creates four measurement gaps that self-report and standard ePRO cannot close.
Phase 1 patients reported no dissociation, sedation, or psychosis. The next step is proving it objectively, with vocal, facial, and movement biomarkers benchmarked against immediate-release ketamine, so the reduced-monitoring claim is unassailable.
ALA-3000's value comes from sustained out-of-clinic effect. Phase 2 needs continuous remote behavioral capture between visits to prove durability, not just inferred from MADRS at week 4 and week 8.
ALA-3000's commercial case requires evidence comparable to Spravato's ECHO data, but for a drug administered without the 2-hour in-clinic observation. That comparison is built on multimodal behavioral data, captured at scale.
When ALA-3000 launches, it could reach patients Spravato cannot. Adherence monitoring, response prediction, and patient identification all need to be designed in from Phase 2 forward, not bolted on at NDA.
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 ALA-3000.
A clinical-grade camera and directional audio rig that drops into any ALA-3000 trial site in minutes. It captures every injection and post-dose interaction with consistent framing, angles, and audio fidelity. Videra's AI verifies protocol adherence and serves as the objective record for the "no dissociation, no sedation" claim.
Our ASSESS platform analyzes voice, video, and language during and after each ALA-3000 injection. It captures the markers that would indicate dissociation, sedation, or psychosis if present, and tracks antidepressant response across the week-plus window of sustained effect. The objective foundation for the reduced-monitoring claim.
We don't stop at data collection. We build condition-specific algorithms on real patient data, with peer-reviewed results. For ALA-3000, that means a proprietary "reduced-monitoring verified" model that benchmarks vocal and facial biomarkers against immediate-release ketamine, underwriting the differentiation story for regulators and payers.
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 data and immediate-release ketamine comparators, combining vocal, facial, and movement biomarkers to objectively prove ALA-3000's reduced-monitoring profile.
Your priorities for ALA-3000's Phase 2 and beyond, 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.