Nabriva's Lefamulin Positive In Pivotal Study, Stock Surges
Zacks Investment Research | Sep 18, 2017 10:39PM ET
Nabriva Therapeutics plc (NASDAQ:NBRV) announced results from a phase III study where lefamulin demonstrated non-inferiority to Bayer AG’s (OTC:BAYRY) Avelox in treating patients with community-acquired bacterial pneumonia (“CABP”).
Shares surged 37% on Monday, including after-market gains, since the announcement of the news. In fact, Nabriva’s shares have outperformed the industry with a gain of 48.8% so far this year. The industry gained 15.6% in the period.
LEAP 1, the first of the two phase III studies on lefamulin, compared intravenous (IV) or oral administration of the candidate to IV/orally administered Avelox, with or without adjunctive linezolid, in CABP patients. The study achieved the FDA set endpoint of non-inferiority (12.5%) in early clinical response (“ECR”) over 72 to 120 hours after the start of the therapy in intent to treat (“ITT”) patients. Lefamulin also met the non-inferiority margin of 10% set by the European Medicines Agency.
Lefamulin achieved an ECR rate of 87.3% compared with 90.2% for Avelox. Also, an investigator assessed clinical response rate was 81.7% for lefamulin compared with 84.2% for Avelox in modified ITT patients.
The company is also conducting a second phase III study, LEAP 2, which compares oral administrations of lefamulin and Avelox in patients with moderate CABP. Nabriva expects the enrollment to be completed in the last quarter of 2017 with top-line data expected in March 2018.
The company estimates that there are 5 million people treated for CABP in the United Sates. Although there are a significant number of CABP patients in the country, there are several companies that sell or develop treatments for the indication. Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) announced non-inferiority of its phase III candidate, omadacycline, to Avelox in April 2017. Cempra, Inc. (NASDAQ:CEMP) is also developing solithromycin for treating CABP.
Nabriva Therapeutics AG Price and Consensus
Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.