What happened
After reporting data from a pivotal Phase 3 trial, shares of Paratek Pharmaceuticals (PRTK), a small-cap biotech company focused on next-generation antibiotics, rose by 30% as of 11:10 a.m. EDT on Tuesday.
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So what
Paratek reported top-line results from its OPTIC study. This trial was designed to test the safety and efficacy of its investigational antibiotic drug omadacycline compared to the moxifloxacin in treating community-acquired bacterial pneumonia, or CABP.
The 774-patient study showed that omadacycline was able to meet all of the study's primary and secondary endpoints. Specifically, omadacycline demonstrated non-inferiority in the intent-to-treat population at the early clinical response, or ECR, of 72-120 hours after initiation of therapy. Omadacycline ECR rate was 81.1%, while moxifloxacin's rate was 82.7%. In addition, omadacycline was generally shown to be safe and well-tolerated by patients.
Paratek's CEO Michael Bigham stated:
This Phase 3 study in pneumonia along with our previously announced successful Phase 3 study in skin infections satisfy the regulatory filing requirements of our special protocol assessment with the FDA. We look forward to sharing these data with the FDA and EMA.
He also stated that the company plans on submitting a New Drug Application to the FDA in early 2018. A European filing is expected soon after.
Traders cheered the upbeat clinical data and proposed regulatory timeline.
Now what
Paratek has been on a quite a roll recently. Just last week, the company and its partner Allergan (AGN) announced data from two phase 3 trials regarding sarecycline, a hopeful treatment for severe acne. The companies stated that sarecycline met the primary efficacy endpoints of the studies. As a result, Allergan stated that it plans on submitting a New Drug Application to the FDA later this year.
Turning to omadacycline, CABP remains an enormous problem in the U.S. Estimates show that the disease is responsible for 3.3 million hospitalizations each year, and that CAPB also has a mortality rate of more than 5%. These figures are telling of the desperate need for new treatment options. Given these statistics, it is easy to understand why the FDA has already granted omadacycline with both Qualified Infectious Disease Product designation and Fast Track status.
With strong phase 3 data in hand, Paratek appears to have a decent shot at winning regulatory approval for both sarecycline and omadacycline within the next two years. That makes Paratek a stock biotech investors will want to keep an eye on.
