SCYNEXIS Announces Agreement With FDA on Innovative Strategy for Approval of Oral Ibrexafungerp for Treatment of Invasive Candidiasis

SCYNEXIS, Inc. recently announced initiation of a global Phase 3 study to evaluate the efficacy, safety, and tolerability of oral ibrexafungerp as a step-down therapy for patients with invasive candidiasis and/or candidemia following intravenous (IV) echinocandin therapy in the hospital compared to currently-available outpatient therapies.

“We believe that ibrexafungerp, with its activity against fluconazole-resistant strains, is perfectly suited to provide a much-needed alternative as a step-down oral treatment for invasive candidiasis to allow patients to leave the hospital and continue treatment with a potent fungicidal therapy,” said Marco Taglietti, MD, President and Chief Executive Officer of SCYNEXIS. “Through our collaborative dialogue with the FDA, we have agreed to an innovative study design that provides an expeditious path to gain regulatory approval of ibrexafungerp for a hospital-based indication.”

The global Phase 3 multi-center, prospective, randomized, double-blind study of two treatment regimens will evaluate oral ibrexafungerp as a step-down treatment in patients suffering from invasive candidiasis (IC) compared to oral fluconazole. Eligible hospital patients with IC will receive treatment with IV echinocandin and will then be switched to either oral ibrexafungerp or oral fluconazole once step-down criteria are met. Approximately 220 patients will be enrolled and randomized in the study.

The primary objective of the study is to determine whether treatment of IC with IV echinocandins followed by oral ibrexafungerp is as effective as treatment with IV echinocandins followed by oral fluconazole, the current standard of care. The primary end point of the study will be all-cause mortality at 30 days after initiation of antifungal therapy.

There will also be an open label arm to evaluate oral ibrexafungerp compared to the best available therapy in patients with azole-resistant infections. Approximately 35,000 cases of IC in the US per year are caused by Candida species that are resistant to azoles, for which ibrexafungerp could provide a much-needed oral alternative.

“Invasive fungal infections are extremely challenging, and there is a significant need for antifungals that can support long-term step-down treatment strategies,” said David Angulo, MD, Chief Medical Officer of SCYNEXIS. “The development program of ibrexafungerp is designed to take advantage of key attributes of the drug, including its oral bioavailability, potent fungicidal activity against Candida species, including most species resistant to other antifungal agents such as azoles and echinocandins, and high tissue distribution which permits it to reach deep-seated infections. There is a very exciting opportunity for oral administration, which is key to optimizing patient care during a prolonged treatment period for invasive fungal diseases that may last from weeks to months.”

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The US FDA approved BREXAFEMME (ibrexafungerp tablets) on June 1, 2021. The FDA also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. The European Medicines Agency has also granted orphan product designation for the indication of IC. Ibrexafungerp is formerly known as SCY-078.

SCYNEXIS, Inc. is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the US, BREXAFEMME (ibrexafungerp tablets). The FDA approved BREXAFEMME on June 1, 2021. In addition, late-stage clinical investigation of oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.