SCYNEXIS Clinical Update Does Not Ruffle Any Feathers
SCYNEXIS Inc. (NASDAQ: SCYX) shares remained relatively flat on Tuesday after the company provided a clinical update for its antifungal agent. Specifically, the company announced two new development milestones for SCY-078.
Based on the available safety and pharmacokinetics data from SCY-078 Phase 1 intravenous (IV) Program, SCYNEXIS has identified an IV formulation and dose regimen that, pending discussions with the FDA, it plans to test in the upcoming clinical trials of SCY-078.
Additionally, the SCY-078 toxicology program was expanded to include three-month oral dose studies in two species (rats and dogs). Consistent with findings from prior non-clinical toxicology studies of shorter durations, these longer-term toxicity studies confirmed the favorable safety profile of oral SCY-078.
Ultimately, these results would allow flexible treatment regimens of SCY-078 for up to three months in the next stages of clinical development, which is particularly relevant for patients with invasive aspergillosis or refractory fungal infections.
Marco Taglietti, M.D., President and CEO of SCYNEXIS , commented:
These latest successful milestones in our SCY-078 development program reflect its versatility in dosing and long-term tolerability for treating a variety of fungal infections. The benefits of both IV and oral formulations would allow SCY-078 to be used as a treatment against invasive fungal infections in multiple settings and indications. We are advancing SCY-078 to the next stages of development, with all key elements now in place: (i) both oral and IV formulations available; (ii) in vitro and in vivo data showing broad spectrum antifungal activity, including activity against azole- and echinocandin-resistant strains; (iii) promising clinical activity observed in two recently completed Phase 2 studies; and (iv) a well-characterized safety and tolerability profile in toxicology studies and in more than 300 patients and subjects exposed to SCY-078.
Shares of SCYNEXIS were trading at $3.44 Tuesday morning, with a consensus analyst price target of $12.13 and a 52-week trading range of $1.74 to $6.89.