RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Viamet Pharmaceuticals today announced that VT-1129, a potent and selective, oral, antifungal agent, has been granted orphan drug designation by the U.S. Food & Drug Administration (FDA) for the treatment of cryptococcal meningitis, a life-threatening invasive fungal infection of the lining of the brain and spinal cord. Viamet expects to submit an investigational new drug (IND) application for VT-1129 to the FDA during the first half of 2015.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same indication for that drug during that time period. The applicable period is seven years in the United States.
VT-1129 has been shown in preclinical studies to be a potent and selective, orally available inhibitor of fungal CYP51. VT-1129 blocks the production of ergosterol, an essential component of the fungal cell membrane, which is critical to fungal proliferation and survival. Additionally, VT-1129 has demonstrated substantial potency against Cryptococcus species and high concentrations within the central nervous system in preclinical studies. As a result of these advantageous properties, we selected VT-1129 for further preclinical development targeting the treatment of cryptococcal meningitis, a life-threatening fungal infection of the lining of the brain and the spinal cord. This infection occurs most often in immunocompromised patients, including those with HIV, transplant recipients and oncology patients. A study published in February 2013 in the scientific journal PLOS ONE estimated that there are 3,400 hospitalizations associated with cryptococcal meningitis annually in the United States.
About Viamet (www.viamet.com)
Viamet is a biopharmaceutical company focused on the discovery, development and commercialization of novel antifungal agents based on a proprietary metalloenzyme medicinal chemistry platform, the Metallophile® Technology. The Company is using this platform to design drugs that are expected to have greater selectivity, fewer side effects and improved potency compared to currently available antifungal agents. The Company’s lead product candidate, VT-1161, is an oral agent that is being developed for the treatment of recurrent vulvovaginal candidiasis, or RVVC, a highly prevalent mucosal infection for which there are no approved therapies in the United States, and onychomycosis, a very common fungal infection of the nail for which current treatments are suboptimal with respect to safety, tolerability and efficacy. The Company’s pipeline also includes preclinical programs, including VT-1129, that the Company is developing to treat life-threatening invasive fungal infections.
This press release includes forward-looking statements. Actual results may vary materially from these statements. There are many important risks affecting Viamet’s business, VT-1161 and VT-1129, including that clinical trials may not be commenced, or if commenced, may not be successful, regulatory approvals may not be obtained and approved products, if any, may not achieve commercial success.