4M Therapeutics Reports Positive Results from 4MT2001 GLP Safety Studies

SKILLMAN, NJ--(BUSINESS WIRE)--4M Therapeutics Inc. (4MTx), an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative diseases, today reported positive results from completed GLP safety studies for its lead asset, 4MT2001. The full results reinforce the encouraging safety profile observed to date and demonstrate a significant therapeutic window for safe dosing. There were no adverse effects on the cardiovascular system at any dose level.

In the studies, dogs, equal sex per group, were dosed at 0, 2.5,10, and 20 mg/kg/day once daily for 28 days with 4MT2001. Rats, equal sex per group, were dosed at 0, 25,100, and 200 mg/kg/day once daily for 28 days with 4MT2001. A complete necropsy was conducted on Day 29 (end of dosing phase) and Day 43 (end of recovery phase). Toxicokinetics, gross pathology, histopathology, labs, and clinical observations were conducted. The studies were intended to support targeted exposure of 4MT2001 at 20-120 mg/day for efficacy in humans.

Based on laboratory results and pathology, high 4MT2001 exposures were tolerated. In dog at 10 mg/kg/day over 28 days C_max was 5,900 ng/ml with an AUC_0-24 of 84,000 ng·h/ml. In rat at 100 mg/kg/day over 28 days C_max was 1,300 ng/ml with an AUC_0-24 12,000 ng·h/ml. These results indicate a greater than 10x safety window for dosing.

4MT2001 28-day repeated dosing at 2.5, 10 or 20 mg/kg showed no cardiovascular test-article related changes with telemetry. No test article-related changes were observed in blood pressure, heart rate, body temperature or ECG parameters (PR, QRS, QT and QTc intervals) with no abnormal ECG waveform.

“We are highly encouraged by the incremental data generated in our GLP toxicity studies that support the potential of 4MT2001 to provide a safer treatment options to patients who are currently underserved by lithium and atypical antipsychotics and their safety limitations,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-Founder of 4M Therapeutics. “We are now well positioned for our anticipated Phase 1 trial to begin in 2026.”

About 4M Therapeutics Inc.

4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative conditions. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaboration between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.