May 25, 2021 at 5:00 PM EDT
- Lefamulin was shown to be non-inferior to moxifloxacin, with 76.8% of lefamulin-treated patients meeting the efficacy endpoint of Investigator Assessment of Clinical Response (IACR) at Test of Cure (TOC), compared to 71.4% of patients treated with moxifloxacin
- Lefamulin was generally safe and well-tolerated in Chinese adults
- Greater Chinese rights to lefamulin will be held by Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
HONG KONG, SHANGHAI, China, SUZHOU, China and DUBLIN, Ireland, May 25, 2021 (GLOBE NEWSWIRE) — Sinovant Sciences, a Chinese biopharmaceutical company dedicated to conducting innovative biomedical R&D in China, and Nabriva Therapeutics (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced positive topline results from Sinovant’s Phase 3 bridging study of lefamulin in Chinese adults with community acquired bacterial pneumonia (CABP).
Sinovant’s multi-center, randomized, double-blind trial was designed to evaluate the safety and efficacy of intravenous (IV) to oral lefamulin compared to IV/oral moxifloxacin in 125 subjects with CABP. Subjects were randomized 2:1 to lefamulin and moxifloxacin and stratified by prior antibiotic exposure, pneumonia severity index (PSI) risk class, and renal impairment. Study drugs were dosed in double-dummy double-blinded fashion (lefamulin: 150 mg IV every 12 hours, 600 mg oral every 12 hours; moxifloxacin: 400 mg IV once daily, 400 mg oral once daily).
Lefamulin met the primary endpoint of non-inferiority vs. moxifloxacin for Investigator Assessment of Clinical Response at Test of Cure (IACR-TOC) in the modified intent to treat (mITT) population, with success rates of 76.8% (n = 63/82) for lefamulin and 71.4% (n = 30/42) for moxifloxacin. This finding was consistent across subgroups. On the key secondary endpoint of IACR-TOC in the clinically evaluable (CE) population, success rates were 86.0% (n = 49/57) and 86.2% (n = 25/29) in the lefamulin and moxifloxacin arms, respectively. These results are similar to those observed in the global Phase 3 LEAP 1 and LEAP 2 clinical trials conducted by Nabriva.
Consistent with previously reported clinical trial results, lefamulin was observed to be generally safe and well-tolerated, with an overall rate of treatment-emergent adverse events (TEAEs) comparable to that of moxifloxacin. The vast majority of TEAEs in both treatment arms were mild-to-moderate in severity, with serious adverse events (SAEs) occurring in 4% of lefamulin-treated patients and 10% of moxifloxacin-treated patients. TEAEs leading to discontinuation were uncommon and observed in just 5% of subjects in both treatment arms.
“We are delighted with the results of this trial,” said Dr. Rae Yuan, CEO of 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 China’s NMPA as soon as possible.”
In addition, Sinovant has entered into an agreement with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma, to acquire development and commercialization rights for lefamulin in Greater China. Under the terms of that agreement, Sinovant will assign its license agreement for lefamulin to Sumitomo Pharmaceuticals (Suzhou), the terms of which are otherwise unchanged. Closing of this transaction is subject to certain conditions and is expected to occur in the second calendar quarter of 2021.
“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. 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 lefamulin’s life cycle in China,” said Steve Gelone, President and COO of 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.”
Full PR available here