SCYNEXIS Inc（SCYX）のニュースとイベントSCYXSCYNEXIS Inc

SCYNEXIS Plans to Advance SCY-770 into Phase 2 Clinical Trial by Year-End

"We are working to advance SCY-770 into a Phase 2 proof-of-concept clinical trial by the end of this year. We believe that our highly selective and direct AMP-activated protein kinase (AMPK) activator has the potential to be a differentiated therapy for ADPKD, a serious progressive disease that affects about 140,000 people in the United States alone," said David Angulo, President and Chief Executive Officer of SCYNEXIS. "In our Phase 1 study, SCY-770 was well tolerated at higher doses than previously evaluated, and the pharmacokinetic and safety data generated will support dose selection for planned Phase 2 trial. Our goal is to bring patients a new, well-tolerated oral treatment option for a disease with significant unmet need and limited therapeutic options."

Scynexis Announces SCY-247 Trial Results, Secures $214M BARDA Contract

Scynexis announced topline results from its Phase 1 single ascending dose, or SAD, and multiple ascending dose, or MAD, trial of the intravenous, or IV, formulation of SCY-247, its second-generation triterpenoid antifungal candidate. SCY-247 is under development in both oral and intravenous formulations for the treatment and prevention of invasive fungal infections with the potential to provide therapeutic advantages by having activity against drug-resistant fungi. Recently, Scynexis was awarded a BARDA contract providing up to approximately $214M in non-dilutive funding, if milestones are achieved, to advance the development of SCY-247. The award is structured as a cost-share arrangement, with BARDA providing support for eligible SCY-247 costs. The company expects to fund its share of near-term program costs for SCY-247 within its existing operating plan. The company's previously communicated development plans for SCY-770 to initiate a Phase 2 study in the fourth quarter of 2026 and the company's projected cash runway into 2029 remain unchanged. The study evaluated the safety and characterized the pharmacokinetics of intravenous SCY-247 to inform progression to, and dose selection for, a Phase 2 study in patients with invasive candidiasis. The Phase 1 study enrolled 56 healthy participants across seven cohorts: 42 received SCY-247 by peripheral intravenous infusion and 14 received placebo. The study evaluated single ascending doses up to 300 mg and multiple ascending doses administered once daily for seven days up to 200 mg. SCY-247 administered by peripheral intravenous infusion was generally well tolerated. The most commonly reported adverse reactions were mild to moderate erythema and pain at the infusion site. There were no drug-related serious adverse events or discontinuations due to a related adverse event. Intravenous doses of 50 mg once daily or higher achieved exposures at or above the efficacy target identified in murine models of invasive candidiasis. A previously completed Phase 1 study indicated that oral doses of 100 mg or higher are also anticipated to achieve the target exposure for efficacy. Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247. Further details of the results from this study will be presented at an upcoming scientific meeting. Invasive candidiasis is associated with high mortality, and resistance to the limited available antifungal options is making treatment increasingly challenging. Designed to address these limitations, SCY-247 has demonstrated in vitro and in vivo activity against several challenging Candida strains, including Candida auris, as well as most azole- and echinocandin-resistant strains. SCY-247 has been granted Orphan Drug, Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA.

Scynexis Completes Phase 1 Study of SCY-770

Scynexis announced completion of a Phase 1 study of SCY-770, a selective and direct AMP-activated protein kinase activator. The study was conducted to evaluate the safety and tolerability, as well as to characterize the pharmacokinetics of SCY-770 to support dose selection for the Phase 2 study in patients with Autosomal Dominant Polycystic Kidney Disease. The Phase 1 study enrolled 25 healthy participants across three cohorts. In the initial cohort, participants received a single 500 mg dose of SCY-770 under fed and fasted conditions. Participants in the subsequent cohorts received SCY-770 at either 750 mg once daily or 500 mg twice daily, or placebo, for seven days. SCY-770 was well tolerated across all cohorts and demonstrated a safety profile consistent with prior clinical experience. Pharmacokinetic data from this and prior studies will inform dose selection for the Phase 2 trial in patients with ADPKD, which remains on track to initiate in the fourth quarter of 2026. The safety and tolerability of SCY-770 has been well-characterized across multiple clinical trials in approximately 300 participants to date. SCY-770 has been granted Orphan Drug Designation by the FDA for the treatment of ADPKD.