Press release: FURI Study: Clinical trial with an innovative treatment, SCY-078, in patients with Candida infections started in Europe
Clinical Trials Centre Cologne (CTCC) manages the study conduct in Europe; University Hospital of Cologne as ECMM Excellence Centre offers a perfect platform for research in fungal diseases.
Fungal diseases are on the rise. Over 1 billion patients are affected and 25 million people are at imminent risk of severe organ damage or death due to fungal infections. Especially the growing global threat of Candida auris, a typically multidrug-resistant fungal species spreading at an increasing rate and associated with significant mortality focus researchers to push clinical development of antifungal compounds. For this reason, a global, open-label study to evaluate the efficacy and safety of SCY-078 in patients with Fungal diseases that are Refractory to or Intolerant of standard antifungal treatment, called FURI, was started at the University of Cologne at the end of October and at the end of November, the first patient was already enrolled. The study is expected to enroll 15 patients across European sites. The sponsor of the study is Scynexis Inc., a US-based biotechnology company delivering innovative anti-infective therapies.
The multicenter, open label, non-comparator, single arm study enrols patients with a documented invasive and/or severe fungal disease caused by Candida, which are potentially difficult-to-treat and life-threatening. Patients must either be intolerant or refractory to Standard of Care antifungal treatment or cannot receive approved oral antifungal options (e.g., susceptibility of the organism or risk for drug-drug interactions) or a continued intravenous antifungal therapy is not desirable or feasible due to clinical or logistical circumstances. All patients will be treated with oral SCY-078, a novel orally bioavailable glucan synthase inhibitor for up to 90 days.
“We are excited to participate in this study that provides a therapeutic option to patients facing fungal infections with limited or no treatment alternatives” said Prof. Oliver Cornely, M.D., principal investigator at the University of Cologne. “The preclinical data of SCY-078 showing consistent activity against resistant Candida strains is very encouraging and, at the University Hospital of Cologne, we are pleased to participate in the development of this innovative antifungal agent”.
The University Hospital of Cologne is one of six sites (together with Essen, Frankfurt, Leipzig, Munich and Wurzburg) in Germany and has recently been announced as ECMM Diamond Excellence Center, one of three treatment centers with high expertise in research and patients care of fungal infections worldwide, led by Oliver Cornely. For the FURI study, in addition to the German sites, two trial sites located in Austria and further sites in the Netherlands, United Kingdom and Spain are expected to open soon.
Study Management is realized by the Clinical Trials Centre Cologne (CTCC)/Zentrum für Klinische Studien Köln, an academic Contract Research Organization of the University of Cologne. CTCC has built up FungiResearch, an international network of experts, research groups and hospitals specializing in the treatment of invasive fungal infections (http://fungiresearch.uni-koeln.de). Initiator and founder is Oliver Cornely. “FURI will definitely profit by this network,“ says Dr. Endrik Limburg, Project Manager and contact person for FungiResearch at CTCC. „FungiResearch accelerates clinical development of antifungal compounds making use of profound expertise of its members and access to a specific pool of patients with unmet medical needs.“
SCY-078 is an antifungal agent in clinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078 is a triterpenoid, semi-synthetic derivative of the natural product enfumafungin—a structurally distinct and novel class of glucan synthase inhibitor. SCY-078 combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having IV and oral formulations. By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains.
The European Confederation of Medical Mycology (ECMM) is the umbrella organization of the European mycological entities. The purpose of ECMM is to provide support to science and research, the international coordination of scientific and clinical activities, the organization of mycological conventions and training programs. Centers throughout the world can apply for ECMM Excellence Center Status. Following such application on site auditing of up to three levels of mycological work (clinical, microbiological, epidemiological/clinical trials) evaluates the excellence of a center along predefined criteria.
The Clinical Trials Centre Cologne (CTCC) as an institution of the Medical Faculty of the University of Cologne bundles expertise for successful design, conduct and publication of clinical trials. As experienced research partner it offers competence and the infrastructure required for faculty members as well as academic and industrial partners. The principal task of the Clinical Trials Centre Cologne (CTCC) is the conduct of clinical trials in compliance with GCP, international directives, guidelines and standards.
For further information please contact:
Prof. Oliver A. Cornely MD FECMM
Clinical Trials Centre Cologne / ZKS Köln
Gleueler Strasse 269
D – 50935 Köln