Wikipedia
Omadacycline (formerly known as PTK-0796) is a broad spectrum antibiotic belonging to the aminomethylcycline subclass of tetracycline antibiotics. Paratek Pharmaceuticals, Inc. is developing omadacycline as a treatment for serious community-acquired infections.
In vitro studies have shown that omadacycline has activity against a broad range of Gram-positive and select Gram-negative pathogens. This activity translated to potent efficacy for omadacycline in an In vivo systemic infection model in mice.
Additional In vitro and In vivo studies of omadacycline metabolism, dispositon and drug-drug interactions show that omadacycline is metabolically stable (no significant biotransformations) and does not inhibit or interact with metabolizing enzymes or transporters.
The mechanism of action for omadacycline has been shown to be primarily through inhibition of bacterial protein synthesis. Omadacycline has demonstrated activity against bacterial strains expressing the two main forms of tetracycline resistance ( efflux and ribosomal protection).
A Phase 2 study was conducted comparing the safety and efficacy of omadacycline to linezolid for the treatment of complicated skin and skin structure infections (cSSSI). Patients were randomized to receive either omadacycline 100 mg intravenously once daily with an option to transition to 200 mg orally once daily or linezolid 600 mg intravenously twice daily with an option to transition to 600 mg orally twice daily at 11 US sites. The phase 2 trial results support conclusions that omadacycline is well tolerated in cSSSI patients and has the potential to be an effective treatment for serious skin infections.
In June 2013, the US Food and Drug Administration ( FDA) designated omadacycline as a Qualified Infectious Disease Product ( QIDP) for both intravenous and oral formulations in the treatment of acute bacterial skin and skin structure infections ( ABSSSI) and community-acquired bacterial pneumonia (CABP).
A 650 patient Phase 3 registration study known as OASIS (Omadacycline in Acute Skin and Skin Structure Infections Study), comparing omadacycline to linezolid for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) began in June 2015. Omadacycline met the primary efficacy endpoint of early clinical response with statistical non-inferiority (10% margin) compared to linezolid. Omadacycline was generally safe and well tolerated. The most common treatment emergent adverse event was gastrointestinal events (18.0% for omadacycline vs. 15.8% for linezolid).
A 750 patient Phase 3 study comparing omadacycline to moxifloxacin for the treatment of Community Acquired Bacterial Pneumonia (CABP) began in November 2015.
In May 2016, a phase 1b study of omadacycline in Urinary Tract Infection was initiated.
In August 2016, a second, pivotal phase 3 study of omadacycline in patients with ABSSI was initiated. The study will assess the efficacy and safety of once-daily, oral-only omadacycline compared to twice-daily, oral-only linezolid in patients with ABSSSI.