New alliance targets early 2026 for first-in-human trial of non-opioid small molecule

Lisata Therapeutics and GATC Health have announced an expanded strategic collaboration focused on accelerating the clinical development of a novel treatment for opioid use disorder (OUD). The partnership brings together Lisata’s clinical and regulatory capabilities with GATC’s AI-driven Multiomics Advanced Technology (MAT) platform, which is designed to predict drug safety, efficacy and development success with a high degree of accuracy.

The OUD candidate — a non-opioid small molecule — was discovered through GATC’s MAT system and has demonstrated a significant reduction in fentanyl intake in preclinical studies using validated murine models. The program is expected to enter Phase 1 human trials in early 2026, led by Lisata, which will oversee development and regulatory activities.

As part of the agreement, GATC will assume responsibility for all R&D costs related to its development assets, while Lisata will receive milestone payments and royalties on any successfully commercialised products. GATC will receive licensing fees for any assets identified through its AI platform and acquired by Lisata.

“This alliance could serve as a blueprint for how AI and traditional drug development can work together to speed up timelines, improve precision and reduce cost,” said David Mazzo, President and CEO of Lisata. “With AI platforms like MAT, we have a new opportunity to derisk the pipeline from the very beginning and bring more effective treatments to patients faster.”

The collaboration builds on earlier work between the two companies. GATC previously applied its AI analysis to support Lisata’s certepetide program, and under the new arrangement, Lisata will continue to explore combination therapies — including those involving certepetide — identified by the MAT platform across multiple therapeutic areas.

The MAT system integrates large-scale multiomics data with artificial intelligence to generate high-confidence predictions about the likely success or failure of drug candidates. Its predictive reports include assessments of toxicity, mechanism of action, likely efficacy, and potential side effects, aiming to streamline the traditionally long and uncertain early development process.

According to GATC, the MAT platform has achieved 86% sensitivity and 91% specificity in validation studies conducted at the University of California, Irvine. The company believes platforms like MAT are well positioned to support the FDA’s evolving expectations for human-relevant data under its New Approach Methodologies (NAMs) framework — which increasingly prioritises mechanistic, human-based evidence over animal models.

“Lisata brings nearly two centuries of combined development experience to this partnership, with a proven ability to execute efficiently and bring products to regulatory submission,” said Jayson Uffens, CTO at GATC Health. “Their team is ideally suited to lead this asset through clinical development.”

With opioid-related deaths continuing to rise globally and limited non-opioid treatment options available, both companies say the alliance demonstrates how AI-enabled platforms could play a larger role in addressing unmet needs in mental health and addiction.