A pair drug companies are undergoing clinical trials in hopes of receiving approval from the Food and Drug Administration for getting their antifungal medicines in front of the public in 2018.
 If they are approved, they will join a market dominated by drug giants like Merck & Co., Inc. (MRK) Pfizer Inc. (PFE, Financial) and Astellas Pharma Inc. (ALPMY, Financial) over roughly two decades.
Cidara Therapeutics, Inc. (CDTX, Financial) plans on taking its new antifungal drug, Rezafungin Acetate, through the completion of Phase 2 trials as early as this quarter. It plans to start Phase 3 trials by mid-year. It’s the only drug  of its kind under development that requires a dosage of only once per week. It is used to treat candidemia and invasive candidiasis, as well prophylactic treatment of candida, PCP and aspergillus.
The second company, Scynexis, Inc. (SCYX, Financial) is in Phase 2 proof of concept trials in patients with vulvovaginal candidiasis, a topical form of candida also known as a yeast infection. Trials show that the drug can be effective in treating candida infections generally. The medicine is the only echinocandin treatment that can be administrated orally.
Candida itself can be deadly if systemic infection occurs.
Early last year, Cidara’s stock dropped by 40% after Rezafungin failed to prove its effectiveness in treating yeast infections. Results for candidemia, invasive candidiasis and prophylaxis are still pending,
The company is the recipient of a $6.9 million grant from CARB-X, a group created by the U.S. Department of Health and Human Services that focuses on antibacterial products.
The FDA has designated Rezafungin as a Qualified Infectious Disease Product (QIDP) that enjoys Fast Track status and orphan designation for the treatment of candidemia and invasive candidiasis. Cidara is also seeking a QIDP designation, Fast Track status, and orphan designation for prophylactic treatment. The QIDP designation grants the drug five years of market exclusivity, while orphan designation provides an additional seven years, which means that Rezafungin Acetate could enjoy a potential 12-year period of marketing exclusivity if and when it receives FDA approval.
SCY-078 has also attained QIDP status from the FDA, Fast Track status, and orphan designation for oral and IV treatment of invasive candidiasis and invasive aspergillosis.
However, investor caution is warranted because while these clinical trials may show promise, a group of investors has filed two class action lawsuits against the company for failing to disclose health problems among patients in its clinical trials for SCY-078 and for allegedly overstating the medicine’s prospects.
Back in 2001, Merck & Co., Inc. (MRK) brought the first of a new class of antifungals called echinocandins to market with the approval of Cancidas. After 17 years on the market, Cancidas sells over $500 million annually. Mycamine, another echinocandin marketed by Astellas Pharma Inc. (ALPMY, Financial) and approved in 2005, sold close to $360 million in 2016. Pfizer Inc. (PFE, Financial) had its own echinocandin Eraxis approved in 2006.
Disclosure: Long CDTX
