China National Medical Products Administration Approves Sinovant’s Clinical Trial Application for Lefamulin
Chinese registrational clinical trial for lefamulin to begin in 2H 2019
BEIJING and SHANGHAI, June 14, 2019 /PRNewswire/ Sinovant Sciences today announced that its Clinical Trial Application (CTA) for lefamulin has been accepted by the Center for Drug Evaluation at the China National Medical Products Administration (NMPA), enabling the initiation of registrational clinical trials for patients with community-acquired bacterial pneumonia (CABP) in the second half of 2019.
“The approval of our CTA for lefamulin is a significant moment in the field of antibiotics in China,” said Dr. Rae Yuan, President of Sinovant. “High rates of resistance to existing antibiotics, particularly among the pathogens responsible for CABP, reduce the efficacy of historic first-line therapeutics and compromise millions of patients’ chances of recovery. With its differentiated and novel mechanism of action, lefamulin has the potential to become a preferred first-line empiric monotherapy for CABP, and we are eager to deliver this important new medicine to Chinese patients.”
Lefamulin is a novel antibiotic of the pleuromutilin class being developed as a potential treatment for community-acquired bacterial pneumonia (CABP). CABP is one of the leading causes of mortality in China.
“This CTA approval is an exciting moment for us,” said Dr. Xinan Chen, Executive Chairman of Sinovant. “We are looking forward to embarking on the next chapter for Sinovant as we advance lefamulin into the clinic.”
Lefamulin is a semi-synthetic pleuromutilin antibiotic which works by selectively inhibiting translation of bacterial protein synthesis. In pre-clinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that most commonly cause CABP, including multi-drug resistant strains. Due to its novel mechanism of action, low incidence of cross-resistance between other antibacterial agents commonly used to treat CABP, and low propensity for bacterial resistance to develop1, lefamulin has the potential to be used as a first-line empiric monotherapy for the treatment of CABP. Sinovant’s partner Nabriva has completed two global Phase 3 studies of lefamulin in patients with moderate and severe CABP. In both studies, lefamulin was demonstrated to be non-inferior to moxifloxacin, and met both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) primary and secondary efficacy endpoints for the treatment of CABP. Lefamulin was also shown to be generally well-tolerated when administered either orally or intravenously. New Drug Applications (NDAs) and a Marketing Authorization Application (MAA) for both the oral and intravenous formulations of lefamulin were submitted to the US FDA, and the European Medicines Agency (EMA) in the fourth quarter of 2018 and the second quarter of 2019, respectively. Both NDAs have been granted priority review and the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review is August 19, 2019.
About Community-Acquired Bacterial Pneumonia
Widespread use of antibiotics has created high resistance to common first line antibiotics among causative pathogens, and industry estimates suggest there are as many as 18 million new cases of CABP each year in China.2,3
Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D in China to meet the needs of patients in Greater China and around the world. Sinovant's mission is to develop and commercialize new medicines that address the most pressing public health challenges in China while simultaneously advancing Chinese biopharmaceutical research abroad.
For further information, please visit: www.sinovant.com
1 Veve MP, Wagner JL. Pharmacotherapy 2018; 38(9):935-946
2 Pereyre S et al. Front Microbiol 2016; 7:974
3 Leerink Partners research