SKILLMAN, N.J.--(BUSINESS WIRE)--4M Therapeutics Inc. (4MTx), an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative diseases, today announced new preclinical data for its lead program, 4MT2001, a novel small molecule glycogen synthase kinase 3 beta (GSK3β) inhibitor, that demonstrated clear central nervous system (CNS) target engagement paralleling its positive effects on animal behavior.
“The preclinical target engagement data further validate our accelerated development of 4MT2001,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-Founder of 4M Therapeutics. “We expect to begin dosing in our GLP toxicology (animal safety) studies over the next few weeks, and we remain on track to initiate a Phase 1 trial for 4MT2001 in 2025.”
In preclinical studies, low doses of 4MT2001 produced statistically significant reductions in brain pCRMP2 levels and brain PKC substrates (p<0.05) versus dextroamphetamine (D-AMPH). The biomarker pCRMP2 is a highly specific indicator of GSK3β activity, and previous studies have shown lithium also reduces brain levels of both pCRMP2 and PKC substrates. The effects of 4MT2001 on these two key CNS biomarkers and the positive results previously shown on two measures of animal behavior (motion and vocalizations) support the profile of 4MT2001 as a potent, targeted, and safer mood stabilizer for people with bipolar disorder and other CNS conditions.
Dr. Lapuerta will present these target engagement data, along with preclinical data examining the efficacy of 4MT2001 on amphetamine-induced positive appetitive ultrasonic vocalizations (USVs), at the upcoming 26th Annual Conference of the International Society for Bipolar Disorders, taking place from September 29 to October 1, 2024, in Reykjavik, Iceland. Details of the presentation are below.
Session Title: New & Trending Oral Session IX
Presentation Title: Novel Small Molecule Inhibitor of GSK3β for the Treatment of Bipolar Disorder
Presentation Date and Time: October 1, 2024, from 9:50 AM to 10:00 AM GMT (5:50 AM to 6:00 AM EDT)
About 4M Therapeutics Inc.
4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative diseases. 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.
