- Some potential good news for those fighting antibiotic resistance – two Phase 3 trials of Paratek Pharmaceuticals' omadacycline presented at IDWeek 2017 have confirmed the antibiotic's efficacy and safety, as well as its effectiveness against a broad spread of pneumonia bacteria, including resistant bugs. Filing is likely to begin in December 2017.
- In the OASIS-1 study, in patients with acute bacterial skin and skin structure infections (ABSSSI) and hard-to-treat co-morbid conditions, omadacycline was as safe and effective as linezolid and didn't require any dose adjustments.
- In the OPTIC study, microbiological data showed that omadacycline was effective against clinically important typical and atypical community-acquired bacterial pneumonia (CABP) pathogens, both Gram-positive and Gram-negative. Monotherapy with omadacycline was safe and effective in patients with CABP infected with the most frequently isolated pathogens.
Editor's Note: A previous version of this article incorrectly stated that omadacycline was developed by Transcept Pharmaceuticals.
The threat of microbial resistance is increasing, with a potential loss of life rising to 10 million by 2050, and a cumulative cost of $100 trillion. Developing new classes of antibiotics has been increasingly difficult, but Paratek Pharmaceuticals is one that has risen to the challenge.
Paratek's once-daily oral and intravenous omadacycline is one of a new class of compounds, related to the tetracyclines. It has been designed to overcome two of the protection mechanisms behind tetracycline resistance, and is in development for serious community-acquired bacterial infections particularly when antibiotic resistance is of concern. Omadacycline has Fast Track designation, as well as qualified infectious disease product (QIDP) designation under the Generating Antibiotic Incentives Now (GAIN) act, which includes priority review from the Food and Drug Administration and five additional years of market exclusivity.
One of the difficulties in treating CABP is that microbiological confirmation of infection is difficult and a pathogen is only identified in less than 10% of patients. Omadacycline's breadth of activity, as Evan Loh, president, COO and CMO of Paratek, explained, should "lay a foundation for clinicians for its potential use in the CABP setting. The potent activity observed in the microbiology study supports previously reported in vitro data demonstrating that omadacycline is broadly active against multiple CABP pathogens, including resistant pathogens."
Some antibiotics require dose adjustments for use in people with co-morbid conditions such as impaired renal function, diabetes or a high body mass index. One of the outcomes from the OASIS-1 study is that omadacycline should not need these changes in dose, and so can offer physicians the convenience of a fixed-dose, once-daily, oral and IV antibiotic option in patients with community-acquired skin infections.
Under the terms of a special protocol assessment (SPA), Paratek has agreed with the FDA that it can submit omadacycline for approval for both ABSSSI and CABP if the Phase 3 data for both is positive. According to the company, omadacycline has now shown positive data from three Phase 3 registration studies, and could be the first new, once daily, multi-indication, oral antibiotic in over 10 years, with a $9 billion potential market in the U.S. The rolling New Drug Application will begin in December 2017, to be completed in the first quarter of 2018. A European marketing authorization application is planned for late 2018.
The drug is also on the cusp of a Phase 2 study in uncomplicated urinary tract infections (uUTI), and is being assessed under a research agreement with the U.S. Department of Defense against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax. Other potential indications include Lyme disease, prostatitis and rickettsia.
The other clinical stage project in Paratek's pipeline, sarecycline, is expected to be submitted for approval later this year for moderate to severe acne in collaboration with U.S. partner Allergan. Paratek is seeking partners outside the U.S.