Vyera Pharmaceuticals announced plans to initiate a Phase 1 single ascending dose (SAD) study of VYR-006, a novel dihydrofolate reductase (DHFR) inhibitor which Vyera discovered and is developing for the treatment of toxoplasmosis. The United States Food and Drug Administration (FDA) issued a Study May Proceed letter to Vyera on November 6, 2018, in response to Vyera's submission of an Investigational New Drug Application (IND). The letter from the FDA gives permission for Vyera to proceed with dosing human subjects in its Phase 1 SAD study of VYR-006. Vyera intends to begin a multiple ascending dose study pending satisfactory completion of the SAD study.
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"Receiving permission from the FDA to proceed with our Phase 1 study of VYR-006 is a great step forward for us. Vyera's mission from the beginning has been to create and develop new therapies for diseases that are rare and often neglected,” Vyera's Head of Research and Development, Dr. Nicholas Pelliccione said. “The discovery of VYR-006 by our own in-house scientists and now proceeding to a clinical program is the initial fulfillment of that mission for the company and hopefully may lead to a new therapy for patients who require treatment for this serious condition."
Vyera's drug discovery program identified VYR-006 through its efforts to create a toxoplasmosis treatment that will be more potent and better tolerated than existing options. Toxoplasmosis, a parasitic infection caused by Toxoplasma gondii (T. gondii), is a leading cause of death attributed to food-borne illness in the United States. The Centers for Disease Control and Prevention (CDC) identified toxoplasmosis as one of five neglected parasitic infections targeted for public health action. VYR-006 is a new chemical entity and a potent DHFR inhibitor, which has demonstrated efficacy in cell-based and animal models of acute toxoplasmosis. VYR-006, currently a capsule, is expected to be explored further for safety and efficacy in upcoming clinical investigations that are anticipated to take place in the U.S. and a variety of other countries around the world.