Cempra, Inc. announced recently that the U.S. Food and Drug Administration (FDA) has granted a qualified infectious disease product (QIDP) designation to Cempra’s investigational antibiotic product candidate, Taksta™ (CEM-102, sodium fusidate, the sodium salt of fusidic acid). The designation is for Taksta oral tablets for the indication of acute bacterial skin and skin structure infections (ABSSSI).
“Taksta is Cempra’s second antibiotic product candidate to obtain QIDP status, which should enable us to expedite its development and bring this promising drug to the patients who need it the most,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “Previously our lead product, solithromycin, received QIDP status and together we view these designations as further validation of Cempra’s progress in achieving its goal of becoming a leader in the global anti-infective market.”
The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act of 2012. It provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act. The FDA has previously granted QIDP designation to Cempra’s lead product development candidate solithromycin IV and capsules for the treatment of community acquired bacterial pneumonia (CABP) and solithromycin capsules for the treatment of gonorrhea.
Cempra is developing Taksta (fusidic acid) exclusively in the U.S. for acute bacterial skin and skin structure infections (ABSSSI) and is exploring its use for the long term oral treatment for refractory bone and joint infections, including prosthetic joint infections.
Fusidic acid is orally active against gram-positive bacteria, including all Staphylococcus aureus strains such as HA-MRSA and CA-MRSA. Taksta successfully completed a Phase 2 clinical trial in patients with ABSSSI, which is frequently caused by methicillin-resistant Staphylococcus aureus (MRSA), demonstrating a tolerability profile and efficacy comparable to linezolid (sold under the brand name Zyvox®), the only oral antibiotic with FDA approval for the treatment of MRSA. A Phase 2 trial in patients with primarily staphylococcal infections of prosthetic hip and knee joints demonstrated that fusidic acid in combination with rifampin was generally comparable to intravenous standard of care antibiotics.
Based on FDA discussions, Cempra plans to conduct a Phase 3 trial for the treatment of ABSSSI and will conduct an exploratory trial for refractory bone and joint infections. These clinical trials are expected to begin by the end of 2015.