4M Therapeutics Reports Positive Preclinical Data for CNS-Targeting Lead Asset 4MT2001

4M Therapeutics Inc. (4MTx), a biotechnology firm focused on early-stage treatments for neuropsychiatric and neurodegenerative diseases, has announced promising preclinical data for its leading candidate, 4MT2001. This innovative small molecule inhibitor targets glycogen synthase kinase 3 beta (GSK3β) and shows significant engagement with the central nervous system (CNS), aligning with positive behavioral outcomes in animal models.

Dr. Pablo Lapuerta, the CEO and Co-Founder of 4M Therapeutics, expressed optimism regarding the accelerated development of 4MT2001, stating, "The preclinical target engagement data further validate our accelerated development of 4MT2001." The company plans to commence GLP toxicology (animal safety) studies within weeks and aims to initiate a Phase 1 trial by 2025.

In the preclinical trials, low doses of 4MT2001 significantly reduced brain levels of pCRMP2 and PKC substrates compared to dextroamphetamine (D-AMPH). The biomarker pCRMP2 is a specific indicator of GSK3β activity. Previous research has indicated that lithium can similarly reduce brain levels of pCRMP2 and PKC substrates. The effects of 4MT2001 on these CNS biomarkers, coupled with earlier positive findings on animal behavior metrics such as motion and vocalizations, highlight the compound's potential as a targeted and safer mood stabilizer for conditions like bipolar disorder and other CNS ailments.

Dr. Lapuerta is scheduled to present these target engagement data, along with additional preclinical findings on the efficacy of 4MT2001 in reducing amphetamine-induced positive appetitive ultrasonic vocalizations (USVs), at the 26th Annual Conference of the International Society for Bipolar Disorders. The event will be held from September 29 to October 1, 2024, in Reykjavik, Iceland. Specifically, Dr. Lapuerta's presentation, titled "Novel Small Molecule Inhibitor of GSK3β for the Treatment of Bipolar Disorder," is set for October 1, 2024, from 9:50 AM to 10:00 AM GMT (5:50 AM to 6:00 AM EDT).

4M Therapeutics Inc. is dedicated to advancing treatments for a range of neuropsychiatric and neurodegenerative diseases. The company utilizes a living human brain cell platform developed through a partnership with Harvard, MIT, and the University of Washington. This platform helps identify and design more effective and safer therapeutics. The company's pipeline includes potential groundbreaking treatments for conditions such as bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders.

In summary, the new preclinical data for 4MT2001 offers a promising outlook for those suffering from bipolar disorder and other CNS conditions. With continued research and development, 4M Therapeutics Inc. aims to bring innovative and safer treatments to patients worldwide.