ProMIS Neurosciences (Nasdaq: PMN) disclosed interim safety results from its Phase 1B PRECISE‑AD study at the H.C. Wainwright 28th Annual Global Investment Conference on Sept. 15, 2026. The double‑blind, placebo‑controlled trial enrolled 144 patients with mild cognitive impairment or early Alzheimer’s disease across 22 U.S. sites, exceeding its original 100‑patient target. Patients were randomized in a 3:1 ratio to active treatment (PMN310) or placebo for 12 months, with three dose cohorts and an average age of 73 years (58% female).
The six‑month blinded analysis reported zero cases of ARIA‑E, zero treatment‑related serious adverse events, and no treatment‑related dropouts. Infusion reactions were minimal. By contrast, Phase III trials of competitors lecanemab and donanemab have reported ARIA‑E rates of roughly 12% (30% in APOE4 carriers) and 23% respectively, while placebo baselines range from 9% to 14% over 18 months. PMN310 also showed a 15% decline in p‑tau217 levels, whereas untreated patients typically exhibit a 5%‑10% increase over the same period.
The company highlighted its FDA Fast Track designation and a current ratio of 7.85, underscoring a strong balance sheet. ProMIS closed a financing round of up to $175 million in February 2024, backed by Janus, Ally Bridge, Wellington, Deep Track and Great Point Partners, bringing its market capitalization to about $119 million and funding operations through the end of 2027. Full dosing for the PRECISE‑AD study is slated for Dec. 2024, with top‑line results anticipated in Q1 2027.
CEO Neil Warma emphasized the safety advantage, stating that the company’s antibody platform targets misfolded proteins directly, offering a potentially safer and more effective alternative to existing amyloid therapies.
