Viamet Receives Fast Track Designation from the FDA for VT-1129 for the Treatment of Cryptococcal Meningitis

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Viamet
Pharmaceuticals, Inc. today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for VT-1129 for
the treatment of cryptococcal meningitis, a life-threatening fungal
infection of the membranes covering the brain and spinal cord. VT-1129,
an orally available inhibitor of fungal CYP51, has also received orphan
drug designation for the treatment of cryptococcal meningitis and has
been designated a Qualified Infectious Disease Product (QIDP) by the FDA.
Cryptococcal meningitis is a life-threatening fungal infection that
occurs most often in immunocompromised patients such as HIV patients,
transplant recipients and oncology patients. An estimated 3,400
hospitalizations related to cryptococcal meningitis occur annually in
the United States. The disease is widespread in the developing world due
to the high incidence of HIV infection and AIDS, with approximately one
million cases occurring each year, resulting in 625,000 deaths.
VT-1129 is a highly selective inhibitor of fungal CYP51 that has shown
significant potency against Cryptococcus species, the causative
fungal species of cryptococcal meningitis. In preclinical models,
VT-1129 has demonstrated robust activity against Cryptococcus
species as well as the ability to achieve high concentrations within the
central nervous system, the primary site of infection. Viamet is
currently conducting a Phase 1 clinical trial of VT-1129 in healthy
volunteers in the United States.
“We are pleased that the FDA has granted Fast Track designation status
to VT-1129 for the treatment of cryptococcal meningitis, as this
provides the opportunity to deliver this potential life-saving treatment
to patients in a more rapid timeframe,” commented Robert Schotzinger,
M.D., Ph.D., CEO of Viamet. “In preclinical models of cryptococcal
meningitis, VT-1129 demonstrated the ability to fully eradicate the
fungal pathogen from the brain, an astonishing result that leads us to
believe that VT-1129 has the potential to be an important new weapon to
treat this terrible disease.”
About Fast Track Designation
Fast Track is a designation by the U.S. Food and Drug Administration
(FDA) to facilitate the development, and expedite the review of
experimental therapies to treat serious conditions and fill an unmet
medical need. The purpose of the Fast Track program is to get important
new drugs to patients earlier.
About Viamet (www.viamet.com)
Viamet discovers and develops breakthrough therapies based on our
leadership in metalloenzyme chemistry and biology. Our clinical
portfolio includes novel agents to treat both chronic and life
threatening fungal infections. We also leverage our metalloenzyme
expertise in other therapeutic areas including oncology and orphan
diseases. Focusing on the needs of patients and clinicians, we design
our drug candidates to achieve superior efficacy and safety profiles
compared to currently marketed drugs.
This press release includes forward-looking statements. Actual
results may vary materially from these statements. There are many
important risks affecting Viamet’s business, 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. The Viamet group of companies
includes Viamet Pharmaceuticals Holdings, LLC and its operating
subsidiaries, Viamet Pharmaceuticals, Inc., VPS-2, Inc. and VPS-3, Inc.
The Viamet group of companies are based in the Research Triangle Park
region of North Carolina, USA.