Rheos Medicines Receives FDA “Study May Proceed” Letter to Initiate Phase 1 Clinical Study Under its Investigational New Drug Application for RHX-317 for Treatment of Autoimmune and Inflammatory Diseases

CAMBRIDGE, Mass.–()–Rheos Medicines, a biopharmaceutical company bringing molecular targeting and precision treatment to autoimmune and inflammatory diseases, today announced receipt of a “Study May Proceed” letter from the U.S. Food and Drug Administration for a Phase 1 study under the Company’s Investigational New Drug (IND) application for RHX-317, a MALT1 inhibitor. The Phase 1 clinical trial in healthy volunteers will assess the safety, pharmacokinetics and pharmacodynamic responses of RHX-317 as a novel therapeutic strategy to treat autoimmune and inflammatory diseases, including chronic graft-versus-host disease (cGVHD). The trial is expected to initiate in 2H 2022.

“FDA clearance of the IND for RHX-317 marks an important milestone for our lead program. Based on the preclinical data for RHX-317, we believe we have an opportunity to develop a first-in-class MALT1 inhibitor drug for the effective treatment of highly heterogenous autoimmune and inflammatory diseases which affect millions of patients worldwide. While other companies are pursuing clinical development of MALT1 inhibitors for oncology, Rheos is the first company to pursue clinical development in autoimmune and inflammatory diseases,” said Barbara Fox, Ph.D., Chief Executive Officer of Rheos.

The Phase 1 clinical trial will expand on Rheos’s recent findings presented in Frontiers in Immunology, opening a path toward novel therapies that target MALT1 to treat autoimmune and inflammatory disease, while avoiding the reduction in beneficial regulatory T cells (Tregs).

“The IND approval enables continued advancement of our recent data demonstrating effects of a MALT1 inhibitor drug on suppression of pro-inflammatory cell activation, attenuation of multiple inflammatory cytokines, and efficacy in disease models,” said Dania Rabah, Ph.D, Chief Scientific Officer of Rheos.

Rheos has defined the role of MALT1 in cellular metabolism and the company plans to measure metabolic signatures in the clinic following treatment with RHX-317. These data will ultimately allow Rheos to leverage its precision medicine approach to drive patient stratification in complex autoimmune and inflammatory diseases, including cGVHD.

About MALT1

MALT1 (mucosa-associated lymphoid tissue lymphoma translocation protein 1) is a dual-function scaffolding molecule and paracaspase that is expressed preferentially in immune cells. In addition to its role in NF-κB mediated lymphocyte activation and proliferation, Rheos has shown that MALT1 activity is central to the anabolic shift that fuels pathogenic functions of immune cells. Inhibiting MALT1 attenuates the activity of multiple immune cell types simultaneously to dampen the inflammatory response in the activated immune system. Because of its role in cellular metabolism, the effects of MALT1 inhibition can be monitored by metabolite signatures, opening an opportunity to monitor disease and evaluate activity of therapeutics in patients and patient subsets.

About Rheos Medicines

Rheos Medicines is a biopharmaceutical company developing precision medicines to treat autoimmune and inflammatory diseases by identifying and targeting the molecular characteristics and patient subsets for these complex diseases. Using our proprietary MetPM™ platform, the Rheos team integrates an unmatched knowledge base of immunometabolism networks based on bioinformatic integration of genetic, transcriptomic, epigenomic and metabolomic datasets, including from patient data and samples. We have built a pipeline of novel, differentiated drug programs to address autoimmune and inflammatory diseases by targeting fundamental underpinnings of immune system dysfunction while, at the same time, identifying the molecular signatures for patient stratification and selection. Rheos has assembled leading scientists whose discoveries opened the field of immunometabolism, clinicians with a deep understanding of immune-mediated diseases, and an experienced biotech leadership team. Rheos was founded by Third Rock Ventures and is located in Cambridge, MA. For more information, please visit www.rheosrx.com/. We invite you to follow us on LinkedIn and @Rheosrx.

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