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Paratek Announces Positive Phase 3 Study of Omadacycline in Community-Acquired Bacterial Pneumonia
- Omadacycline met all
FDAprimary and secondary endpoints and EMA co-primary endpoints
- Omadacycline was generally safe and well tolerated
- U.S. New Drug Application planned as early as Q1 2018
- Company to host a webcast and conference call for investors at
4:30 PM ETto review top-line results
“This successful study demonstrates the potential of omadacycline to treat community-acquired bacterial pneumonia, a significant and serious health issue,” said
The global, pivotal Phase 3 clinical study known as OPTIC (Omadacycline for Pneumonia Treatment in the Community), compared the safety and efficacy of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for treating adults with CABP. In the study, 774 patients were randomized. Omadacycline met the
The co-primary endpoints for the EMA were 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. Omadacycline demonstrated a high response rate and met statistical non-inferiority 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.
“We now have experience with omadacycline in more than 1,500 patients in our clinical program and we are very pleased with the safety, tolerability, and efficacy profile that we have seen to date,” said
In the study, omadacycline was generally safe and well tolerated, consistent with prior studies of omadacycline. The most common treatment emergent adverse events (TEAEs) in omadacycline-treated patients (occurring in > 3% of patients) were ALT increase (3.7% with omadacycline vs. 4.6% with moxifloxacin) and hypertension (3.4% with omadacycline vs. 2.8% with moxifloxacin). Gastrointestinal adverse events of interest for omadacycline vs. moxifloxacin included: vomiting (2.6% vs. 1.5%), nausea (2.4% vs. 5.4%), and diarrhea (1.0% vs. 8.0%), respectively. There were no cases of clostridium difficile colitis or infection in patients treated with omadacycline, compared with seven cases (1.8%) in patients treated with moxifloxacin.
Rates of TEAEs were 41.1% for omadacycline vs. 48.5% for moxifloxacin. Drug-related TEAEs were 10.2% for omadacycline vs. 17.8% for moxifloxacin. Discontinuation for TEAEs was uncommon, 5.5% for omadacycline vs. 7.0% for moxifloxacin. Serious TEAEs occurred in 6.0% of omadacycline patients and 6.7% of moxifloxacin patients; four of these were considered related to study drug, two for omadacycline and two for moxifloxacin. The mortality rate was 2.1% with omadacycline and 1.0% with moxifloxacin. Drug-related serious TEAEs leading to premature discontinuation of test article were 2.6% with omadacycline and 2.8% with moxifloxacin.
“Community-acquired bacterial pneumonia results in approximately 3.3 million hospitalizations in
Results of this study will be submitted for presentation at an upcoming scientific congress.
Conference Call and Web Cast
The company will host a webcast and conference call for investors at
Domestic callers wishing to participate in the call should dial 877-407-9039 and international callers should dial 201-689-8470. Replays of the call will be available until
About the OPTIC Study Design
The OPTIC study was a double-blind, active-controlled, global, multi-center study that enrolled 774 adult subjects with moderate to moderately severe CABP and included approximately 14% PORT Class II, 57% PORT Class III, and 28% PORT Class IV. Patients initially received IV administration of either 100 mg of omadacycline or 400 mg of moxifloxacin. Study investigators were permitted to switch patients to oral dosing of their assigned drug (300 mg once daily omadacycline or 400 mg once daily moxifloxacin) for a total of 7 to 14 days based on assessment of clinical stability.
Omadacycline is a once-daily oral and IV, well-tolerated broad spectrum investigational antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the
Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights.
For more information, visit www.paratekpharma.com.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and of our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline for the treatment of CABP. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended
Michael LampeScient Public Relations (484) 575-5040 firstname.lastname@example.org Investors: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568