Scynexis hit the market eight months ago with Brexafemme, a long-awaited upgrade in the treatment of vaginal yeast infection.
Now, the New Jersey drugmaker is delivering data for the drug that may help broaden its antifungal reach.
Interim results from the phase 3 FURI and CARES studies show the ability of ibrexafungerp to combat refractory fungal infections in a hospital setting. In the vaginal yeast infection use, the drug is marketed as Brexafemme.
“There is a significant need for a new antifungal therapy,” Scynexis Chief Medical Officer David Angulo, M.D., said in a release. “The data from more than 130 combined patients in our Furi and Cares studies further confirm that oral ibrexafungerp has a potential to play a significant role in very challenging fungal diseases.”
The data come the same day Scynexis revealed that it was selling $45 million worth of stock and warrants in a follow-on offering. The news sent the company's shares tumbling by 22% by the middle of Friday.
In the FURI and CARES trials, of a combined 131 patients, 61% had a complete or partial response (clinical improvement), 22% saw their disease stabilize, 11.5% had no response and 5.3% were indeterminate.
The FURI study is evaluating 113 patients with severe fungal infections who are intolerant to standard antifungal therapy or have refractory fungal infections despite treatment. Among them, 66 patients (58%) saw clinical improvement, while 27 (24%) achieved disease stability.
The CARES trial is studying 18 patients with systemic infections caused by Candida auris, an organism that is resistant to many drugs and can cause death. The Centers for Disease Control and Prevention has classified it as an “urgent threat” to public health. Of these patients, 14 (78%) had improvement while 2 (11%) saw their disease stabilize.
“This research is a key part of our efforts to build a broad antifungal franchise to help treat millions of patients struggling with sever fungal infections,” Scynexis CEO Marco Taglietti said in the release.
The company will present the data and its analysis during the European Congress of Clinical Microbiology and Infectious Diseases, running Saturday through Tuesday in Lisbon, Portugal.
With Brexafemme as its first approved product, Scynexis has projected its peak sales to reach between $400 million and $600 million. The first-in-class treatment, which has been priced at $475 per course, compares favorably to azole drugs such as Pfizer’s Diflucan, which has been on the market for more than two decades.
Brexafemme has shown the ability to kill the fungal cells behind vaginal yeast infections, an area where azole drugs fall short. After its approval last summer, analysts at Cantor Fitzgerald said the med could reach blockbuster territory with more than $1 billion in annual sales.