Multiple development programs and a new class of antifungals — all in a single, and singular, drug
Scynexis is developing a new class of antifungals with its novel drug ibrexafungerp. It has Phase 3 programs in the outpatient market for vulvovaginal candidiasis (VVC) and recurrent VVC and a Phase 3 trial in refractory mucocutaneous infections. Hospital-setting programs are in Phase 3 for refractory invasive fungal infections (rIFI) and Candida auris infections and in a Phase 2 trial for aspergillosis in combination therapies. The drug’s oral form is the most advanced, accounting for all the mid- to late-stage clinical trials; an IV form is in preclinical studies.
WHAT’S AT STAKE
Previous press reports on Scynexis have centered primarily on Candida auris infection — which is now running rampant through group care institutions and looks like a viable target for the company’s pipeline drug. That story makes compelling sense, but it also makes it easy to overlook the more general need for antifungals and the product’s potential for treating a much wider range of drug-resistant strains.
The point is this: We may need new antifungals even more than we need new antibiotics against bacteria and viruses. There are four main classes of disease-causing fungi, and all of them have developed widespread resistance to the few available therapies. C. auris is the extreme example, resisting cleaning and sometimes forcing the replacement of hospital equipment, entire walls, and ceilings. People also can be symptomless carriers of C. auris.
To overcome drug resistance, new antifungals must aim at new targets and employ new mechanisms, even when several drugs share the same target. Ibrexafungerp is in a group of drugs that break down the fungal cell wall, but it does so through a novel mechanism of action (MoA). Multitarget cocktail therapy has become a common strategy for beating a pathogen’s defenses, and being the mechanistic loner increases the odds for a drug’s inclusion in the mix.
Other fungal infections have a longer history of treatment than C. auris, but they can be equally dangerous to patients, in or out of care facilities. Scynexis aims to serve the hospital and outpatient settings because ibrexafungerp appears effective against the particular types of infections found in each. Scynexis President and CEO Marco Taglietti, M.D., says the product’s uniqueness and potentially broad application give it regulatory and business advantages: “We have patent protection for the drug until 2035, and it has the FDA’s Qualified Infectious Disease Product status, which grants five extra years of exclusivity and priority review to the drug’s first application.”
The C. auris scare also has stimulated business and investor interest in the company, Taglietti observes. “For what we know, we believe we are the most advanced in studying a novel agent in patients with C. auris. Of course, now everyone is jumping into it.” In the infectious disease area, at least, most industry players know and appreciate how MoAs can determine different drugs’ role and performance in actual practice. Scynexis is listed on NASDAQ, from which it draws funds, and it also has attracted financial support and nondilutive funding from partnerships and other sources. But Taglietti prefers to keep those stakes in proper perspective, behind the ultimate stakes for patients in this critical area.
“Fungal infections are more and more difficult to control, there is a lack of alternatives, and there are new threats around the corner. This is a business, as my mentors taught me. But they also taught me, ‘Do something good, where something important is at stake, and the money will come.’” In the case of Scynexis, doing good is developing a new class of antifungals and weighing the stakes in anticipation of Phase 3 results in the spring.
Employees: 26 Headquarters: Jersey City, NJ
Finances >200M: Raised since 2014 from public equity and debt offerings, including $62M IPO in May 2014
Research Partnership Funding
Merck: ibrexafungerp initially discovered by Scynexis and developed in research collaboration with Merck.
R-Pharm granted exclusive rights to develop and commercialize ibrexafungerp in Russia, Turkey, and other countries.
Latest Updates November 2019: Positive top-line results from Phase 3 registration study of ibrexafungerp in vulvovaginal candidiasis (VVC)
October 2019: $3.3M nondilutive funding. New Jersey Economic Development Authority Net Operating Loss and R&D Tax Credits Program.
April 2019: ibrexafungerp shows favorable clinical activity in resistant fungal infections, including C. auris.