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news.Cidara Therapeutics, a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, announced the initiation of a Phase 1, randomized, double-blind, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD101 IV in healthy subjects.
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"The advancement of our first product candidate into the clinic ahead of schedule is a significant next step toward our mission to address the urgent need for effective new antifungal treatments," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
"CD101 IV is a novel, long-acting antifungal that could ultimately provide physicians with a new treatment option for their patients fighting serious, life-threatening fungal infections."
Cidara is developing CD101 IV, an agent in the echinocandin class of antifungals, for the treatment and prevention of systemic Candida infections, including candidemia and related cases of invasive candidiasis.
Systemic fungal infections are associated with high mortality rates and typically affect patients whose immune systems have been compromised, such as patients undergoing organ or bone marrow transplantation, chemotherapy, and many patients in ICUs.
"Even with the current armamentarium of antifungals, the mortality rate of candidemia is still 35 percent," said Pete Pappas, M.D., professor of medicine in the Division of Infectious Diseases at the University of Alabama in Birmingham.
"Candida resistance to the standard classes of therapies is rising, increasing the need for new antifungal agents, yet it has been almost a decade since the last agent was approved for candidemia, which leaves physicians with few viable options for patients."
The U.S. Food and Drug Administration (FDA) has designated CD101 IV as a Qualified Infectious Disease Product (QIDP) with Fast Track status. The QIDP and Fast Track designations are for the use of CD101 IV in the treatment of candidemia and invasive candidiasis.