Vyera Pharmaceuticals Receives FDA Clearance To Initiate A Phase 1 Study Of A New Chemical Entity Designed As A Potential Treatment For Toxoplasmosis

NEW YORK, Nov. 15, 2018 /PRNewswire/ -- Vyera Pharmaceuticals, LLC (Vyera) announced it 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), the government agency that oversees pharmaceuticals and clinical research in the U.S., 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.

Vyera's Head of Research and Development, Dr. Nicholas Pelliccione commented, "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. 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."

About VYR-006
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.

About Toxoplasmosis
Toxoplasmosis is caused by the parasite Toxoplasma gondii, and more than 40 million people in the United States may be infected by the parasite, which can persist in the body for a lifetime. A toxoplasma infection could cause serious health problems ranging from flu-like symptoms to causing damage to the brain, eyes and other organs, particularly in pregnant women or individuals who have compromised immune systems. Persons who are ill with toxoplasmosis can be treated with a combination of drugs, and in certain patients it may be necessary to continue medication for the rest of their lives.

About Vyera Pharmaceuticals
Vyera Pharmaceuticals is a United States based biopharmaceutical company committed to developing and commercializing treatments that address serious and rare diseases with high unmet medical needs. Vyera supports programs that offer financial assistance to patients in need and gives discounts to organizations that provide care to underserved populations. Vyera's research and development efforts focus on novel treatment options for toxoplasmosis and other rare or serious health conditions.  https://www.vyera.com/

Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of Vyera (such as statements about potential clinical indications for VYR-006, clinical trial results with VYR-006, potential actions by regulatory agencies, regulatory plans, development programs, proposed indications for product candidates and market potential for product candidates) are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Vyera intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Vyera's actual results to be materially different from its historical results or from any results expressed or implied by said statements. Vyera's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions and the need for regulatory approvals, Vyera's ability to fund development of its technology and to successfully complete clinical trials, the length of time and costs required to complete clinical trials and to submit applications for regulatory approvals, products developed by competing companies, commercial acceptance of Vyera's products, and other factors. Vyera is not responsible for updating events occurring after the date of this press release.

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SOURCE Vyera Pharmaceuticals, LLC