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Paratek Announces Top Line Results of Phase 2 Clinical Studies of Omadacycline in Urinary Tract Infections
Both studies were adaptive studies which included multiple dosage regimens of omadacycline with the objective to identify a dose regimen for further investigation that would be clinically and microbiologically effective in each of the UTI indications to be studied.
The first Phase 2 study, conducted in the U.S., was designed to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral-only omadacycline compared to an oral-only regimen of nitrofurantoin in female patients with cystitis, or uncomplicated urinary tract infections (uUTI). In the study, 225 subjects were randomized to receive one of four omadacycline dosing regimens or nitrofurantoin.
The second Phase 2 study, conducted globally, was designed to evaluate the efficacy, safety, tolerability and pharmacokinetics of once-daily IV or IV-to-oral omadacycline compared to a once-daily regimen of IV-to-oral levofloxacin, in patients with acute pyelonephritis, a common clinical subset of complicated UTI (cUTI). In the study, 201 patients were randomized into four omadacycline dosing regimens or levofloxacin.
In both studies, omadacycline showed generally comparable levels of clinical success to either nitrofurantoin or levofloxacin, as determined by the investigator’s assessment of clinical response at the post-treatment evaluation. However, the microbiological responses were generally lower than the comparators. Consistent with safety results from previously completed pivotal Phase 3 clinical trials, omadacycline was generally safe and well-tolerated in both studies.
Due to the exploratory intent and small numbers of subjects enrolled in each dose in these phase 2 studies, the Company has identified dose regimens that require additional investigation before determining any future development plans for these indications. Additional analyses are ongoing including pathogen-specific level efficacy and relationships of both clinical and microbiological responses to urinary pharmacokinetic data. The Company plans on presenting data from both studies at a future medical conference.
“We are pleased with the innovative design and high-quality conduct of these exploratory Phase 2 adaptive studies, providing data that has both identified potential dose regimens for future investigation and ruled out ineffective ones.” said
Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
SEYSARA® (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.
Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories. For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our clinical development program, UTI clinical trials, future UTI development, overall strategy, products, prospects and potential. 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," "expect," "look forward," "anticipate," "continue," 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 December 31, 2018 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
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Source: Paratek Pharmaceuticals