SCYNEXIS (NASDAQ:SCYX) plans to start a Phase 2 study of its kidney disease candidate SCY-770 by year-end, with an interim analysis expected in the fourth quarter of 2027, CEO David Angulo said at the Guggenheim Innovation Conference.
The company is also preparing a Phase 2 study of its antifungal candidate SCY-247 for approximately mid-2027. The two programs reflect SCYNEXIS’ expansion beyond antifungal medicines following its acquisition of SCY-770, which it is developing for autosomal dominant polycystic kidney disease, or ADPKD.
Kidney disease study plans
Angulo said SCY-770 is designed to activate AMPK, an enzyme involved in cellular metabolism. He said the approach could affect pathways associated with cyst growth, fluid secretion and inflammation in ADPKD. The candidate has been administered to approximately 300 people across clinical trials, he said.
SCYNEXIS recently completed a Phase 1 study testing higher doses than had previously been evaluated. Angulo said those doses were well tolerated and that the results helped inform the doses proposed for Phase 2. The company is discussing the final study design with the U.S. Food and Drug Administration.
The proposed trial would include a year of treatment and three groups: two receiving different doses of SCY-770 and one receiving a placebo. SCYNEXIS intends to enroll patients whose disease is progressing rapidly and assess the drug’s effect on total kidney volume, a measure used to track disease progression.
Angulo said a 50% relative reduction in kidney-volume growth would be a favorable efficacy signal. He cited the performance of tolvaptan, the currently approved therapy, as a benchmark. Both the planned Phase 2 and a potential Phase 3 study would also assess kidney function through glomerular filtration rate, or GFR, he said.
Angulo described a possible path to accelerated approval based initially on kidney-volume data from a Phase 3 study, followed by evidence of an effect on GFR. He said SCYNEXIS expects to disclose additional study details after reaching agreement with regulators.
Antifungal program and federal funding
SCYNEXIS is initially developing SCY-247 for invasive candidiasis, a serious fungal infection that can affect immunocompromised patients. Angulo said the company has completed Phase 1 assessments of both oral and intravenous formulations and is discussing the Phase 2 design with regulators.
The company’s broader plan includes a Phase 2 study followed potentially by two Phase 3 studies: one in invasive candidiasis and another in prevention of invasive fungal diseases. Angulo said having both formulations could allow treatment to begin intravenously and later transition to an oral medicine.
The Biomedical Advanced Research and Development Authority, or BARDA, has committed $18.5 million in an initial funding tranche for SCY-247, Angulo said. The agreement could provide up to $214 million if BARDA exercises all options, with subsequent funding dependent on development milestones.
Cash position and BREXAFEMME
SCYNEXIS reported $63.2 million in cash at the end of September, which Angulo said would fund operations into 2029 and beyond completion of the planned SCY-770 Phase 2 study. He said the company does not expect SCY-247 development to change that runway because much of the program is supported by the BARDA contract.
Angulo also said GSK is working to relaunch BREXAFEMME, an antifungal product developed by SCYNEXIS and fully licensed to GSK. He said GSK has not publicly disclosed a relaunch date. SCYNEXIS remains eligible for sales milestones under the licensing arrangement.
About SCYNEXIS (NASDAQ:SCYX)
SCYNEXIS, Inc is a biotechnology company focused on developing and commercializing innovative antifungal therapies for the treatment of serious and common fungal infections. The company’s research platform is centered on ibrexafungerp, a novel triterpenoid antifungal designed to inhibit glucan synthase, an enzyme important to the formation of fungal cell walls.
SCYNEXIS’s lead product, BREXAFEMME (ibrexafungerp tablets), is an oral antifungal approved in the United States for the treatment of vaginal yeast infections, also known as vulvovaginal candidiasis.
