Second-Generation Antifungal Aims to Address Invasive Fungal Disease
Scynexis developed its investigational fungal compound, SCY-247, which is in phase 1 clinical trials, and the company expects to share top-line data this year.
Late last year, Scynexis announced it had begun its phase 1 trial for its investigational fungal compound, SCY-247, which is a second-generation antifungal compound, from a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids (fungerps).1
“The reality is that there are not too many antifungal agents, or families of compounds, that are really tailored to the adequate treatment for systemic fungal diseases,” Scynexis CEO David Angulo, MD, said. “There are actually only 3 other families of compounds. This is very different from antibiotics.“
The company previously brought its first-generation antifungal, ibrexafungerp, to market. Ibrexafungerp tablets were FDA approved in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. At the time, it represented the first approved treatment in a novel antifungal class in more than 20 years.2
For this new compound, the company would like to see it address the significant threat posed by antimicrobial resistance (AMR) in systemic fungal diseases with high mortality. Scynexis reports that SCY-247 has demonstrated in vitro and in vivo broad-spectrum antifungal activity against multidrug resistant fungal pathogens.1
The phase 1 trial is a randomized, double-blind, placebo-controlled study of single and multiple ascending doses of oral SCY-247 in approximately 100 healthy subjects. The primary endpoint is safety and tolerability, and the secondary endpoint is pharmacokinetics.1
In terms of indications, Angelo points out the company is looking to assess the properties of the compound and complete the phase 1 trial, and then look at specific fungal targets. However, he does see candidiasis as a likely target they will study for treatment with SCY-247.
“SCY-247 is a glucan synthesis inhibitor. The glucan synthesis inhibition is a mechanism that is a fungicidal against Candida species, which really kills Candida very effectively. And for that reason, Candida infections are a logical target,” Angelo said.
However, he also wants to explore the utility of the investigational treatment against Aspergillus as well as infections that affect immunocompromised patients, patients with bone marrow transplants or hematological malignancies.
Angulo says the company is expecting to have the initial results of the phase 1 trial in the third quarter of this year.
