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Press Release 02/08/2018


Vyera Pharmaceuticals, LLC (Vyera) announced the initiation of a Phase 1 single ascending dose (SAD) study of TUR‐006, a proprietary drug candidate with a novel dihydrofolate reductase (DHFR) inhibitor which Vyera discovered and is developing for the treatment of toxoplasmosis. Health Canada, the government agency that oversees pharmaceuticals and clinical research in Canada, granted a No Objection Letter (NOL) to Vyera on December 21, 2017, in response to Vyera's submission of a Clinical Trial Application. Health Canada’s NOL gives permission for Vyera to proceed with dosing the first human subjects in its Phase 1 investigation of TUR‐006. Vyera intends to begin a multiple ascending dose study pending satisfactory completion of the SAD study.

Vyera's drug discovery program identified TUR‐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. TUR‐006 is a new chemical entity and a potent DHFR inhibitor, which has demonstrated efficacy in cell‐based and animal models of acute toxoplasmosis. Vyera has developed TUR‐006 as a solid, oral dosage form, which is scheduled for further exploration in upcoming clinical investigations.

About Vyera Pharmaceuticals

Vyera Pharmaceuticals is a drug company with offices in the United States and Switzerland. Vyera is committed to developing and commercializing treatments that address serious and neglected diseases with high unmet 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 & Development efforts focus on developing novel treatment options for toxoplasmosis and other rare or serious health conditions.

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 TUR‐006, clinical trial results with TUR‐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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