SCYNEXIS announced the company has completed the nonclinical toxicology evaluations that are required by regulatory authorities, including the U.S. Food and Drug Administration (FDA), to support long-term administration in human clinical trials. The toxicology studies were conducted in rodent and non-rodent species for six and nine months, respectively. SCYNEXIS remains on track to submit its first New Drug Application (NDA) to the FDA in 2020.

"The favorable results of these long-term toxicology studies reinforce the safety profile of ibrexafungerp, allowing for patients enrolled in clinical trials to receive oral ibrexafungerp for an extended period of time, and enabling its potential development as a prophylactic agent and as a treatment for chronic fungal infections," said Marco Taglietti, M.D., President and Chief Executive Officer at SCYNEXIS. "A substantial unmet medical need remains for potent antifungal agents that can be safely administered long-term to address difficult-to-treat fungal infections."

Many fungal infections, including chronic pulmonary aspergillosis, bone fungal infection, chronic disseminated candidiasis, chronic mucocutaneous candidiasis and prophylaxis, require long-term antifungal therapy. Regulatory guidelines recommend that drugs intended for long-term use be tested for their safety in rodent and non-rodent species for six and nine months, respectively, in order to identify toxicities that may not have been seen in shorter-term studies but may arise after long-term exposure. Oral ibrexafungerp, administered chronically in these long-term toxicology studies, was not associated with any new safety findings. These results, together with the reproductive and developmental toxicity studies recently reported, complete the core nonclinical toxicology package necessary to support our first NDA planned for 2020.

"Our development program continues to demonstrate the versatile profile of ibrexafungerp, with this favorable nonclinical data on top of the recent positive clinical findings in a variety of difficult-to-treat fungal infections, including multidrug-resistant infections caused by Candida auris," said David Angulo, M.D., Chief Medical Officer at SCYNEXIS. "We believe that the availability of long-term administration, coupled with ibrexafungerp's fungicidal activity against Candida, high tissue penetration, low risk for drug-drug interactions and convenient oral administration, will provide significant advantages over currently available antifungal treatments in a variety of outpatient and hospital infections."

Register as Visitor to CPhI China 2019 NOW!

-----------------------------------------------------------------------
Editor's Note:

If you have any suggestion to the content, 

please email: Julia.Zhang@ubmsinoexpo.com.