Paratek (NASDAQ: PRTK) announced after hours on April 3rd that their lead asset, omadacycline, met its primary and all secondary endpoints in a phase 3 study in patients with CABP.
In this study, omadacycline met the pre-specified FDA endpoint as well as the EMA endpoints of non-inferiority when compared to moxifloxacin. Omadacycline has been granted a special protocol assessment with the FDA, which enables regulatory approval following a single positive registration study in CABP and ABSSSI, both of which have now completed. Based on these results, Paratek expects to submit an NDA in early 2018.
As discussed in our report, similar to other tetracycline antibiotics, omadacycline resulted in no cases of C. difficile infection compared to 7 cases with moxifloxacin.
During the Q&A following the presentation of data, several questions were raised regarding an apparent increase in mortality with the omadacycline arm. However, mortality secondary to CABP is around 5%, which is higher than what was observed with omadacycline.
Paratek is one of AMP Biotech Research's quarterly picks for Q2 2017. AMP is a biotech research firm that publishes a quarterly list of companies with attractive valuations and near-term catalysts. To see all of AMP's picks for Q2 2017, go to www.ampbioresearch.com.
Find the original press release here: http://investor.paratekpharma.com/phoenix.zhtml?c=253770&p=irol-newsArticle&ID=2259424