Nabriva Therapeutics PLC (NBRV) stock prices were down by a marginal 0.67% as of the market closing on May 25th, 2021, bringing the price per share down to USD$1.48 at the end of the trading day. Subsequent pre-market fluctuations saw the stock skyrocket by 45.27%, bringing it up to USD$2.15.
Positive Topline Results
The company announced on May 25th, 2021 that it had achieved positive topline results from Phases 3 of Sinovant’s bridging study of Lefamulin in Chinese adults with community-acquired bacterial pneumonia (CAPB). The multi-center, randomized, double-blind trial was used to evaluate the safety and efficacy of IV to oral lefamulin compared to moxifloxacin in 125 subjects with CAPB.
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The study randomized subjects with two patients being administered Lefamulin for every patient-administered moxifloxacin. The subjects were stratified according to previous antibiotic exposure, pneumonia severity index (PSI) risk class, and renal impairment. Drugs throughout the study were dosed in a double-dummy double-blinded fashion.
Results of Clinical Study
Lefamulin reported achieving its primary endpoint of non-inferiority vs moxifloxacin for IACR-TOC in the mITT population. The success rate of Lefamulin at 76.8% being higher than the 71.4% reported for moxifloxacin is evidence of the success of the study, with the findings being consistent across subgroups. In regard to the key secondary endpoint of IACR-TOC in the CE population, success rates for lefaulin were 86% and moxifloxacin reported a success rate of 86.2%. These results reflect the results of the global Phase 3 LEAP 1 and LEAP 2 clinical trials conducted by NBRV.
Potential of Lefamulin
Consolidating previous findings, Lefamulin was observed to be generally safe and well-tolerated. Overall rate of treatment-emergent adverse events (TAEAs) were found to be compared to that of moxifloxacin. An overwhelming majority of TAEAs in both Lefamulin and moxifloxacin arms ranged from mild to moderate severity. Serious adverse events (SAEs) occurred in 4% patients treated with lefamulin and 10% occurred in moxifloxacin-treated patients. Only 5% of subjects reported TAEAs that resulted in discontinuation in either treatment arm.
Collaboration with Suzhou
Sinovant also entered into an agreement with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., with the aim of acquiring development and commercialization rights for Lefamulin in the Greater China region. As per the agreement, Sinovant will assign Suzhou its license agreement for Lefamulin. The completion of this transaction is contingent on certain conditions and is forecasted to occur in the second calendar quarter of 2021.
Future Outlook for NBRV
With the disclosure of the highly promising topline results from their clinical trial, NBRV is poised to push for the commercialization of its treatment. Current and potential investors are hopeful in the company’s ability to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.