SCYNEXIS completes Phase 1 IV study of SCY-247 antifungal
SCYNEXIS has reported topline results from its Phase 1 single ascending dose and multiple ascending dose trial of intravenous SCY-247, a second-generation triterpenoid antifungal candidate. The New Jersey-based company said the drug was generally well tolerated in healthy participants, with no drug-related serious adverse events and no treatment discontinuations linked to adverse reactions. The most commonly reported side effects were mild to moderate erythema and pain at the infusion site.
The Phase 1 study enrolled 56 healthy participants across seven cohorts. Forty-two received SCY-247 by peripheral intravenous infusion and 14 received placebo. Doses ranged from single administrations up to 300 mg and multiple once-daily doses up to 200 mg over seven days. The company said intravenous doses of 50 mg once daily or higher achieved plasma exposures at or above the pharmacokinetic target derived from murine models of invasive candidiasis, specifically an AUC of 20 micrograms per hour per millilitre over a 24-hour period.
Clinical and regulatory context
Todd Minga, SVP of Research and Development at SCYNEXIS, said the completion of Phase 1 studies for both the oral and intravenous formulations allows the company to refine its Phase 2 plans. "Having both intravenous and oral formulations could provide flexibility in managing patients with invasive candidiasis and those at risk of invasive fungal diseases," he said. SCYNEXIS expects to initiate a Phase 2 study in 2027, subject to agreement with the FDA. Full Phase 1 data will be presented at an upcoming scientific meeting.
The programme carries three FDA designations: Orphan Drug, Qualified Infectious Disease Product, and Fast Track. These designations can accelerate regulatory review and, in the case of the Orphan Drug designation, confer seven years of US market exclusivity on approval. SCYNEXIS's existing commercial antifungal asset, ibrexafungerp, was licensed to GSK and was the first approved fungerp-class agent, giving the company established proof of concept for the triterpenoid mechanism.
Backing the programme's progression is a contract from the Biomedical Advanced Research and Development Authority, awarded as contract number 75A50126C00007. The contract provides up to approximately $214 million in non-dilutive funding contingent on milestone achievement, structured as a cost-share arrangement. SCYNEXIS said it expects to fund its share of near-term programme costs within its existing operating plan, and its cash runway projection into 2029 remains unchanged.
Competitive landscape
Invasive candidiasis is a high-mortality infection increasingly complicated by resistance to the existing antifungal arsenal, which is dominated by azoles, echinocandins, and polyenes. Candida auris, in particular, has attracted significant public health attention owing to its multi-drug-resistant profile and nosocomial spread. SCY-247 has demonstrated in vitro and in vivo activity against Candida auris as well as azole- and echinocandin-resistant strains, a profile that differentiates it from most currently approved agents.
Several other companies are pursuing novel antifungal mechanisms, and the sector has gained momentum partly because of the historically thin drug-development pipeline relative to antibacterials. BARDA's willingness to fund SCY-247 development reflects broader US government concern about antimicrobial resistance preparedness. For investors, the key near-term catalysts will be FDA alignment on the Phase 2 design and the initiation of that study, alongside Phase 2 progress on SCY-770, the company's separate candidate for autosomal dominant polycystic kidney disease, which is expected to enter Phase 2 in the fourth quarter of 2026.