Paratek Pharmaceuticals Inc (NASDAQ:PRTK) has announced successful Phase 3 clinical trials of its pipeline oral antibiotic Omadacycline.
The trial compared single daily doses of the antibiotic with double daily doses of oral drug linezolid which is also used to treat acute bacterial skin as well as skin structure infections. According to the announcement, the study achieved its primary and secondary endpoints.
“This successful study demonstrates the potential of an oral-only dosing regimen of omadacycline, which would enable treatment in the outpatient setting and potentially reduce the need for admission to the hospital,” stated Michael Bigham, the CEO of Paratek.
Bigham further pointed out that the oral dosing regimen of Omadacycline has potential advantages to prescribers and patients who are searching for new and effective ways of dealing with skin infections. The Phase 3 drug trial, also known as OASIS-2 was conducted to determine the safety and efficacy of single daily oral doses of Omadacycline compared to double daily doses of linezolid which is also an oral-only treatment.
According to the phase 3 trial report, Omadacycline was able to achieve its primary statistical non-inferiority endpoint as specified by the FDA. The report stated that the early clinical response (ECR) rate of the drug was 87.5 percent in 48 to 72 hours after the first dose compared to 82.5 percent for Linezolid. It also added that the treatment achieved its EMA-specified co-primary endpoints during the post therapy evaluation (PTE). Omadacycline’s PTE clinical success rate was 84.2 percent compared to 80.8 percent for Linezolid.
The conclusion from the Phase 3 trials was that Omadacycline has achieved a high clinical success rate in treating infections caused by ABSSSI pathogens. It also demonstrated a low rate of discontinuation at 10.9 percent versus 14.2 percent for Linezolid. According to the reports, less than 2 percent of the patients discontinued the treatment due to adverse effects.
Paratek stock closed the latest trading session at $24.95.
