FDA Grants QIDP And Fast Track Designation To CD101 Topical, Cidara Therapeutics’ Novel Antifungal Product Candidate

SAN DIEGO--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that the U.S. Food and Drug Administration (FDA) has designated the company’s novel antifungal product candidate, CD101 topical, as a Qualified Infectious Disease Product (QIDP), with Fast Track status for its development program. The designation is for the development of CD101 for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC (RVVC).

Seventy-five percent of women worldwide suffer from VVC in their lifetime, and four to five million women in the United States alone have the recurrent form of the infection, which is caused by Candida. According to the Centers for Disease Control and Prevention (CDC), certain species of Candida are becoming increasingly resistant to existing antifungal medications. This emerging resistance intensifies the need for new antifungal agents.

The QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for the development of new antifungal and antibacterial drugs, including Fast Track, priority review and, if CD101 topical is ultimately approved by the FDA, eligibility for an additional five years of marketing exclusivity.

“The QIDP and Fast Track designations for CD101 topical will enable Cidara to speed the development of this compound, which is the first echinocandin antifungal to be developed as a topical treatment. Coupled with the earlier QIDP and Fast Track designations for CD101 IV, we now have the opportunity to expedite the development of CD101 for both systemic and local fungal infections,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.

CD101 topical is the first topical agent in the echinocandin class of antifungals and exhibits a broad spectrum of activity against Candida species. Cidara plans to commence a Phase 2 comparative clinical trial of CD101 topical in VVC (the RADIANT study) in mid-2016.

Most VVC occurs in women of childbearing potential (the infection is common in pregnant women), but it affects women of all ages. In a recent safety communication, the FDA advised caution in the prescribing of oral fluconazole for yeast infections during pregnancy based on a published study concluding there is an increased risk of miscarriage. The Centers for Disease Control and Prevention (CDC) guidelines recommend using only topical antifungal products to treat pregnant women with vulvovaginal yeast infections. Vaginal infections are associated with a substantial negative impact on day-to-day functioning and adverse pregnancy outcomes including preterm delivery, low birth weight, and increased infant mortality in addition to predisposition to HIV/AIDS.

To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. These pathogens include Candida species, which have the potential to pose a serious threat to public health.

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. CD101 IV is being developed as a once-weekly high exposure therapy for the treatment and prevention of serious, invasive fungal infections. CD101 topical is being developed for the treatment of vulvovaginal candidiasis (VVC) and the prevention of 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. For more information, please visit www.cidara.com.

Forward-Looking Statements

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, safety, long-acting nature, anticipated human dosing and other attributes of CD101 IV and CD101 topical, and their potential to treat infections, as well as 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 Form 10-Q most recently filed with the United States Securities and Exchange Commission. 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.