AI-Discovered Drug for ALS Shows Promise in Phase 2 Trials
A drug candidate for ALS discovered using AI-powered molecular design has shown significant efficacy in Phase 2 clinical trials, slowing disease progression by 35% compared to placebo and raising hopes for the first effective ALS treatment in decades.
Insilico Medicine has announced positive Phase 2 clinical trial results for ISM-7248, a drug candidate for amyotrophic lateral sclerosis (ALS) that was discovered and optimized using the company's AI-powered drug design platform. The drug slowed disease progression by 35% compared to placebo over a 12-month treatment period.
ISM-7248 was identified by Insilico's Chemistry42 AI system, which generated the novel molecular structure from scratch by analyzing the biological pathways involved in motor neuron degeneration. The AI system evaluated billions of potential molecular configurations before identifying ISM-7248 as the optimal candidate.
The trial enrolled 240 patients across 30 sites in the US and Europe. Patients receiving ISM-7248 showed significantly slower decline on the ALS Functional Rating Scale compared to placebo, with the treatment group also showing preservation of respiratory function and fewer hospitalizations.
The timeline from AI-generated molecule to Phase 2 results was 30 months, compared to the typical 6-8 years for conventional drug development to reach this stage. Insilico CEO Alex Zhavoronkov noted that AI acceleration of early-stage drug discovery is beginning to translate into real clinical outcomes.
A Phase 3 trial is planned to begin in Q3 2026, with potential FDA submission in 2028. If approved, ISM-7248 would be the first ALS drug developed using AI to reach the market and one of the most effective treatments for the disease in decades.
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