Antifungal specialist Scynexis has nabbed Nkechi Azie, M.D., as its vice president of clinical development from her role as infectious disease head at The Medicines Company.
She comes on board about five months after the New Jersey-based biotech posted new data from the phase 3 test of ibrexafungerp, a drug it hopes will be an approvable first-in-class antifungal.
The results published back in January came from the first 20 of a planned 60 patients in the so-called FURI trial, which focused on invasive yeast infections caused by Candida species in patients that have failed multiple antifungal therapies and are at high risk of dying.
It showed that oral dosing of ibrexafungerp (previously known as SCY-078) as a "salvage" therapy showed evidence of efficacy in 17 of them, with 11 complete or partial responders and six people whose disease stabilized.
Fungal infections claim an estimated 1.5 million deaths each year, but only a handful of drug classes have been successfully developed for the treatment of life-threatening, invasive fungal diseases including polyenes like amphotericin B, azoles such as fluconazole and echinocandins including Merck’s Cancidas (caspofungin) and Astellas’ Mycamine (micafungin).
That means there is an undeniable need for new treatment options, particularly as some fungal species such as C. glabrata and C. auris have been identified that are resistant to both azoles and echinocandins. The FURI trial mainly involved infections caused by C. glabrata and C. krusei, organisms prone to antimicrobial resistance.
Ibrexafungerp is a member of the glucan synthase inhibitor class but has a novel triterpenoid structure that Scynexis says combines high antifungal activity with the potential to be delivered both intravenously and orally. It also has positive midstage data in vulvovaginal candidiasis (VVC) and invasive candidiasis (IC).
Azie comes on board “in anticipation of ibrexafungerp's potential approval and commercial launch,” the biotech noted, and will report to Chief Medical Officer David Angulo, M.D.
"We are pleased to welcome Nkechi to the Scynexi team, where her extensive clinical and medical affairs experience in infectious diseases will be instrumental in our efforts to bring ibrexafungerp to patients in need," said Angulo.
"Nkechi has successfully and effectively launched several antifungal products and managed their life cycles. With our phase 3 program for vulvovaginal candidiasis (VVC) well underway, her expertise strengthens our readiness for the next stages of ibrexafungerp's development and potential commercialization. Nkechi's deep understanding of the infectious disease space aligns well with the team here at SCYNEXIS, and we look forward to her contributions as we advance the ibrexafungerp program across multiple important indications."
She joins after exiting her role as VP of medical affairs at The Medicines Company, where she managed the company’s infectious disease franchise, as well as previous stints at Astellas and Pfizer.
"I am thrilled to join the SCYNEXIS team and support their mission to deliver effective and innovative therapies for difficult-to-treat and often life-threatening infections," said Azie. "This is an exciting time for the Company as ibrexafungerp is in Phase 3 development with a potential New Drug Application submission for VVC in 2020. Ibrexafungerp has significant potential to be an essential therapy for physicians and patients in need of new treatment options for multiple serious and often life-threatening fungal infections."
Back in 2017, Scynexis was hit hard after three healthy volunteers in a phase 1 trial of an IV formulation of its drug SCY-078 developed blood clots. The drug was originally developed by Merck & Co., which called it MK-3118. The biotech has since been working to bounce back.