Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today 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.
“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.
More information about this trial will be available soon at ClinicalTrials.gov.
About Cidara Therapeutics
Cidara is a clinical stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment of diseases that are inadequately addressed by current standard-of-care therapies. Cidara’s initial product portfolio comprises two formulations of the company’s novel echinocandin, CD101, for the treatment of serious fungal infections. CD101 IV is a long-acting therapy for the treatment and prevention of systemic fungal infections, and CD101 topical is for the treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), a prevalent mucosal infection. In addition, Cidara has developed a proprietary immunotherapy platform, Cloudbreak™, designed to create compounds that direct a patient’s immune cells to attack and eliminate pathogens that cause infectious disease. Cidara is headquartered in San Diego, California.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effectiveness and long-acting nature of CD101 IV and the intended design of current and future Cloudbreak compounds. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara’s plans to develop and commercialize its product candidates; Cidara’s ability to obtain additional financing; Cidara’s ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara’s documents most recently filed with the United States Securities and Exchange Commission (SEC), including its Registration Statement on Form S-1 declared effective by the SEC on April 14, 2015, under the heading “Risk Factors.” All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Source: Cidara Therapeutics, Inc.
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