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Paratek Pharmaceuticals releases omadacycline topline results
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Omadacycline is effective in treating acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, according to topline results presented at the European Congress of Clinical Microbiology and Infectious Diseases.
Paratek Pharmaceuticals presented data from two studies — OASIS-2 and OPTIC — that evaluated the efficacy and noninferiority of a once-daily omadacycline treatment for acute bacterial skin and skin structure infections (ABSSSIs), including MRSA, and community-acquired bacterial pneumonia (CABP).
The phase 3 double-blind, randomized OASIS-2 trial compared omadacycline with linezolid in 735 patients with moderate to severe ABSSSI. According to the study, patients received 450 mg of oral omadacycline once daily for the first 2 days and then 300 mg orally once daily, or 600 mg of linezolid orally twice daily. Treatment duration for both study arms lasted 7 to 14 days, and treatment efficacy was evaluated 48 to 72 hours after the first dose. Researchers said the efficacy of omadacycline was effective and comparable to linezolid in wound infections (82% vs. 77%), cellulitis/erysipelas (88% vs. 93%) and major abscesses (84% vs. 79%).
“The omadacycline clinical data continue to demonstrate the utility of oral-only omadacycline dosing, which would enable treatment of ABSSSI in the outpatient setting and potentially reduce the need for hospital admission,” Evan Loh, MD, president, chief operating officer and chief medical officer for Paratek, said in a press release.
Continuing to examine the safety and efficacy of omadacycline, Paratek’s global phase 3 OPTIC clinical study analyzed 774 patients categorized as Class III or Class IV on the Pneumonia Severity Index (PORT). Researchers compared patients receiving omadacycline intravenously once daily to those receiving moxifloxacin intravenously twice daily using approval guidelines from the European Medicines Agency. Both antibiotics were administered intravenously for at least 3 days and, if predefined clinical stability criteria were met, patients transitioned to oral treatment. Treatment lasted 7 to 14 days, and efficacy was measured 5 to 10 days after the last dose was administered, according to the study.
Omadacycline was shown to be a noninferior and an efficacious treatment for adults with CABP when compared with moxifloxacin, researchers said.
In February, Paratek announced that it submitted two new drug applications to the FDA for once-daily oral and IV formulations of omadacycline for the treatment of ABSSSIs and CABP.
The company said it plans to submit marketing authorizations for omadacycline in Europe in the second half of 2018.
“These study results demonstrate the potential of omadacycline to treat community-acquired bacterial pneumonia, a leading cause of death globally, in the context of the European Medicines Agency’s rigorous evaluation criteria,” Loh said. – by Marley Ghizzone
References:
O’riordan WD, et al. Abstract O0425. Presented at: European Congress of Clinical Microbiology and Infectious Diseases; April 21-24, 2018; Madrid.
Garrity-Ryan L, et al. Abstract P0272. Presented at: European Congress of Clinical Microbiology and Infectious Diseases; April 21-24, 2018; Madrid.
Disclosure: Loh is president, chief operating officer and chief medical officer for Paratek.