Paratek Submits NDAs for Oral & IV Formulations of Omadacycline

Paratek Pharmaceuticals announced today that they have completed submission of 2 New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for once-daily oral and IV formulations of omadacycline, a broad-spectrum investigational antibiotic that is the first in a new class of tetracycline antibiotics known as aminomethylcyclines. The company is seeking FDA approval of the antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), based on the results of 3 phase 3 studies. Omadacycline was previously designated a Qualified Infectious Disease Product and granted Fast Track designation for these indications, by the FDA. These provide for a Priority Review of the NDAs, once they are accepted.

Speaking on the implication of these submissions in the press release, Evan Loh, MD, President, COO & CMO of Paratek stated, "The completion of our NDA submissions marks a significant milestone for Paratek and we are deeply grateful to the patients, investigators, and entire Paratek team for their commitment to advancing omadacycline’s development path to this major milestone. With antibiotic resistance on the rise, we look forward to working with the FDA during the regulatory review process with the goal of bringing a modernized tetracycline antibiotic, omadacycline, to clinicians and patients for the treatment of serious community-acquired bacterial infections.”

As previously reported by Contagion^® , top-line results released in April 2017 on a global phase 3 clinical study revealed that the antibiotic met all FDA primary and secondary endpoints and European Medicines Agency (EMA) co-primary endpoints. Specifically, the trial showed that omadacycline met the FDA-specified primary endpoint of statistical non-inferiority (NI) in the intent-to-treat (ITT) population (10% NI margin, 95% confidence interval) compared to moxifloxacin at the early clinical response (ECR) 72 to 120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1 % and 82.7%, respectively. FDA-specified secondary endpoints of statistical NI at the post-treatment evaluation (PTE) visit 5 to 10 days after the completion of therapy in both the ITT population (87.6% for omadacycline vs. 85.1% for moxifloxacin) and in the clinically evaluable (CE) population (92.9% for omadacycline vs. 90.4% for moxifloxacin) as determined by investigators.

Co-primary endpoints for EMA included: Non-inferiority in the ITT and CE CABP populations in those patients with Pneumonia Severity Index (PORT) III and IV at the PTE time point, and high response rate and statistical NI to moxifloxacin for both populations using a prespecified 97.5% confidence interval. High success rates were observed with response rates of 88.4% (omadacycline) vs. 85.2% (moxifloxacin) and 92.5% (omadacycline) vs. 90.5% (moxifloxacin), respectively. In addition, omadacycline was determined to be generally safe and well-tolerated, which is consistent with prior studies.