Sinovant Sciences and Nabriva Therapeutics Announce Positive Topline Results from Phase 3 Trial of Lefamulin

In 125 CABP subjects, Sinovant conducted a multi-center, randomized, double-blind trial to compare intravenous (IV) safety and efficacy to oral lefamulin versus IV/oral moxifloxacin.

FREMONT, CA: Sinovant Sciences, a biopharmaceutical company dedicated to conducting innovative biomedical research in China, and Nabriva Therapeutics, a biopharmaceutical company focused on the commercialization and development of novel anti-infective agents to treat serious infections, announced positive topline results from Sinovant’s Phase 3 bridging study of lefamulin in Chinese adults with Community-Acquired Bacterial Pneumonia (CABP).

“We are delighted with the results of this trial,” said Dr. Rae Yuan, CEO, Sinovant. “These data strongly support the use of lefamulin as an empiric monotherapy for CABP, a disease that affects millions of Chinese patients annually. We look forward to submitting an NDA to Chinas NMPA as soon as possible.”

In 125 CABP subjects, Sinovant conducted a multi-center, randomized, double-blind trial to compare intravenous (IV) safety and efficacy to oral lefamulin versus IV/oral moxifloxacin. Prior antibiotic exposure, pneumonia severity index (PSI) risk class, and renal impairment were used to stratify the subjects who were given lefamulin and moxifloxacin in a 2:1 ratio. The medications used in the study were dosed in a double-dummy, double-blinded method (lefamulin: 150 mg IV every 12 hours, 600 mg oral every 12 hours; moxifloxacin: 400 mg IV once daily, 400 mg oral once daily).

In the modified intent to treat (mITT) population, lefamulin met the primary endpoint of non-inferiority vs. moxifloxacin for Investigator Assessment of Clinical Response at Test of Cure (IACR-TOC), with success rates of 76.8% (n = 63/82) for lefamulin and 71.4 percent (n = 30/42) for moxifloxacin. All subgroups shared this conclusion. In the clinically evaluable (CE) population, success rates in the lefamulin and moxifloxacin arms were 86.0 percent (n = 49/57) and 86.2 percent (n = 25/29), respectively, on the primary-secondary goal of IACR-TOC. These findings are identical to those shown in Nabriva’s global Phase 3 LEAP 1 and LEAP 2 clinical studies. 

Lefamulin was shown to be generally safe and well-tolerated, with a rate of Treatment-Emergent Adverse Events (TEAEs) comparable to that of moxifloxacin, as previously described in clinical trials. The majority of TEAEs were mild to severe in intensity in both treatment arms, with serious adverse events (SAEs) occurring in 4 percent of lefamulin-treated patients and 10 percent of moxifloxacin-treated patients. TEAEs that led to treatment cessation were infrequent, occurring in only 5 percent of individuals in both treatment arms.

In addition, Sinovant has agreed to purchase development and commercialization rights for lefamulin in Greater China from Sumitomo Pharmaceuticals (Suzhou), a wholly-owned subsidiary of Sumitomo Dainippon Pharma. Sinovant will assign its lefamulin license agreement to Sumitomo Pharmaceuticals (Suzhou) under the terms of that agreement, which will remain unaltered. The transaction is scheduled to close in the second calendar quarter of 2021, subject to certain conditions.

“We are excited to accelerate the availability of lefamulin to Chinese patients upon approval,” said Naoki Noguchi, Chairman, and CEO of Sumitomo Pharmaceuticals (Suzhou). “These data demonstrate that lefamulin has the potential to be an important new treatment option for patients with CABP. In addition, Lefamulin is highly complementary to our existing anti-infective product portfolio in China and we expect it will contribute to our sustained growth in this market.”

“We are eager to enter into the next phase of lefamulins life cycle in China,” said Steve Gelone, President and COO, Nabriva. “Sumitomo Pharmaceuticals (Suzhou)s established commercial infrastructure, particularly in the anti-infectives segment, makes them an ideal partner for Nabriva as we continue to expand global access to lefamulin. We look forward to working with Sumitomo Pharmaceuticals (Suzhou) colleagues to bring this important new medicine to patients.”