The ID Pipeline: FDA Activity From the Week of October 27, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of October 27, 2019.

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of October 27, 2019.

Top Line Results Released From Phase 2 Paratek Pharmaceuticals Study of Omadacycline for Urinary Tract Infections

On Thursday, October 31, 2019, Paratek Pharmaceuticals announced top line results from 2 phase 2 studies evaluating the efficacy and safety of once-daily oral and intravenous (IV) omadacycline in patients with 2 common forms of urinary tract infections (UTIs).

The trials involved multiple dosage regimens to identify one that would be clinically and microbiologically effective. The first evaluated the efficacy, safety, tolerability, and pharmacokinetics or oral-only omadacycline compared with an oral-only regimen of nitrofurantoin in female patients with cystitis. The study was conducted in the United States and comprised 225 subjects. The second trial was conducted globally and sought 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.

In both trials, the study drug showed generally comparable levels of clinical success, but microbiological responses were generally lower than comparators. Additionally, omadacycline was generally safe and well-tolerated.

“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,” Evan Loh, MD, CEO of Paratek, said in a statement. “Beyond these top-line data, we have more data to evaluate from these studies in order to determine the best path forward for omadacycline in UTI. We are grateful to the patients, principal investigators, clinical site staffs, our CRO and vendor partners, and the Paratek clinical development team who participated in and enabled these studies to be executed in a timely and professional manner.”

The full press release is available here.