SCYNEXIS Provides Corporate and SCY-078 Pipeline Update
"In 2017, we made significant progress in advancing the clinical development of SCY-078 in indications addressable and approvable with an orally-administered antifungal therapy," said
Dr. Taglietti continued: "We are excited about our strategic plans for 2018, when we envision SCY-078 advancing in multiple Phase 2 and Phase 3 trials to maximize the broad potential clinical utility of SCY-078 in addressing unmet medical needs in VVC, invasive candidiasis, invasive aspergillosis and refractory invasive fungal infections."
Path Forward Established for IV Program of SCY-078, with Clinical Trials to Initiate in the Third Quarter of 2018 with an Improved IV Formulation
As previously disclosed in
- Broad Pre-clinical Program Executed to Address the Clinical Hold. Based on subsequent interactions with the
FDA, SCYNEXIScompleted a broad range of pre-clinical activities designed to identify the underlying cause of the thrombotic events and to evaluate the optimal administration regimen for the cyclodextrin-based IV formulation of SCY-078. In parallel, SCYNEXIScontinued its pursuit of alternative IV formulations.
- No Intrinsic Pro-Coagulant Effect of the SCY-078 Compound. Several pre-clinical studies showed that SCY-078 does not affect blood coagulation by itself, providing supporting evidence that the thrombotic events associated with the administration of the cyclodextrin-based IV formulation were triggered by vascular endothelium inflammation at the site of infusion.
Accelerated Developmentof a Liposomal IV Formulation of SCY-078. During 2017, SCYNEXISaccelerated the development of a new formulation based on liposomal technology. This technology has been successfully used to improve systemic tolerability of other commercially available IV formulations.
- Favorable Profile of the Liposomal IV Formulation of SCY-078.
SCYNEXIScompared the cyclodextrin-based IV formulation head-to-head against the liposomal IV formulation of SCY-078 in pre-clinical evaluations, and the liposomal formulation showed a superior profile for infusion-related tolerability and vascular inflammation.
- Pre-clinical Activities Ongoing to Enable Planned Human Studies of the Liposomal IV Formulation of SCY-078. Based on these initial pre-clinical studies, SCYNEXIS believes that the liposomal IV formulation may offer significant clinical benefits over the cyclodextrin-based IV formulation and, therefore, decided to focus its efforts on the advancement of the liposomal IV formulation of SCY-078. This decision was discussed with the
FDAand a path forward was established. Additional pre-clinical studies are ongoing, and SCYNEXISintends to initiate a Phase 1 study in healthy volunteers in the third quarter of 2018, pending FDA'sreview.
- Phase 2b Study in Invasive Candidiasis. Upon successful completion of the Phase 1 study in healthy volunteers,
SCYNEXISplans to initiate a Phase 2b study of SCY-078 in invasive candidiasis with the liposomal IV formulation in the fourth quarter of 2018.
Clinical Development of Oral Formulation of SCY-078 Continues to
- VVC – Most Advanced Stage of Clinical Development, Targeting Both Acute and Recurrent Infections.
- Rapid Recruitment in the Phase 2 Dose-finding DOVE Study. In
August 2017, SCYNEXISinitiated dosing in the Phase 2 study, designed to evaluate the safety and efficacy of the oral formulation of SCY-078 vs. oral fluconazole, the standard of care, for the treatment of VVC. Robust enrollment in the trial has been maintained, and SCYNEXIScontinues to expect top-line results in mid-2018. In a previously conducted, proof-of-concept, Phase 2a study in VVC patients, SCY-078 showed high clinical cure and low recurrence rates.
- Initiation of Phase 3 Program Planned for the Fourth Quarter of 2018.
SCYNEXISanticipates that the dose regimen selected from the DOVE study will be subsequently evaluated in Phase 3 studies following an End-of-Phase 2 meeting with the FDA. SCYNEXISexpects to initiate the Phase 3 clinical program in the fourth quarter of 2018.
- Refractory Invasive Fungal Infections – Potential for Streamlined Development Pathway.
- Enrollment Ongoing in the FURI Study for the Treatment of Patients with a
Wide Rangeof Candida spp. Infections with Limited or No Treatment Options. Sixteen sites in the U.S and Europeare now active in this open-label study, and enrollment is progressing as planned.
- CARES Study Opened for Enrollment for the Treatment of Patients with Candida auris Infections.Systemic infections caused by C. auris, a pathogen that is often multidrug-resistant, are associated with high mortality. The CARES study is designed to provide rapid access to oral SCY-078 for patients with this life-threatening and difficult-to-treat infection. This emergency protocol allows for expeditious site initiation upon request from investigators.
- Both FURI and CARES Studies Designed as Pivotal Trials to Support a Potential Approval. The open-label design of these studies allows for evaluation of the data on an interim basis to further inform subsequent regulatory steps of the development program.
- Invasive Aspergillosis – SCY-078 in Combination with Standard of Care May Represent a Significant Opportunity to Improve Outcomes for this High-Mortality Infection.
- Favorable Profile of SCY-078.
SCYNEXISbelieves that SCY-078's broad activity against Aspergillus spp., including azole-resistant strains, along with its minimal drug-drug interactions, high tissue penetration into the lungs and oral formulation allowing for long-term administration, make it an ideal candidate for use as combination therapy to provide improved outcomes vs. standard of care.
- Promising In Vitro and In Vivo Data with Combination Use of SCY-078 and Standard of Care vs. Aspergillus spp. In recent pre-clinical studies, the combination of SCY-078 with other antifungal agents resulted in significantly better outcomes when compared to treatment with single agents.
- Plan to initiate Phase 2 Study in the Third Quarter of 2018. This initial study in patients with invasive aspergillosis is planned as a randomized, double-blind trial with the objective of assessing the safety and efficacy of oral SCY-078 in combination with azole therapy, the standard of care for this indication.
SCYNEXISis finalizing the study design and expects to start this clinical study in the third quarter of 2018.
2018 Key Upcoming Milestones
- Complete enrollment and announce top-line study results of the Phase 2b study of oral SCY-078 as a treatment for VVC in mid-2018.
- Initiate the Phase 1 clinical trial to evaluate the safety and tolerability of the liposomal IV formulation of SCY-078 in healthy volunteers in the third quarter of 2018.
- Initiate a Phase 2 study of oral SCY-078 in combination with current standard of care as a treatment for invasive aspergillosis in the third quarter of 2018.
- Upon successful completion of the Phase 1 study, initiate a Phase 2b clinical trial designed to evaluate IV/oral SCY-078 for the treatment of invasive candidiasis.
SCYNEXISexpects to initiate this study in the fourth quarter of 2018.
- Initiate the Phase 3 program for VVC in the fourth quarter of 2018.
- Continue to advance enrollment in both the FURI and CARES studies, both in the U.S. and globally, with preliminary data review planned for the fourth quarter of 2018.
Conference Call Details
SCY-078 is an investigational antifungal agent that is a semi-synthetic derivative of the natural product enfumafungin. SCY-078 is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having IV and oral formulations. SCY-078 is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum of antifungal activity, in vitro and in vivo, against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The FDA granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.
Forward Looking Statement
Statements contained in this press release maybe, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in