Cempra Initiates Phase 2/3 Clinical Study For CEM-102

Cempra Pharmaceuticals (Cempra) has initiated phase 2/3 clinical study with CEM-102 for patients suffering from acute bacterial skin structure infections (ABSSI).

Reportedly, the first of two pivotal trials is an adaptive design, randomised, double-blind, multi-center study to evaluate the safety and efficacy of orally-administered CEM-102 compared to linezolid in the treatment of ABSSIs.

The company estimates enrollment of 880 patients with a diagnosis of an ABSSI that would be expected to require 10 to 14 days of antibacterial therapy.

In addition to CEM-102, Cempra’s macrolide, CEM-101, will soon enter a phase 2 clinical trial for moderate to moderately-severe community-acquired bacterial pneumonia. Both CEM-102 and CEM-101 will potentially address key antibacterial needs identified by the Infectious Disease Society of America.

Prabhavathi Fernandes, CEO of Cempra, said: “It is well-known that MRSA and bacterial resistance against the current arsenal of antibacterials are rising at alarming rates, and new antibiotics, especially oral drugs, are needed to combat this growing problem. This compound, previously approved outside the US to treat staphylococcal infections, has shown activity against a range of difficult-to-treat and drug-resistant infections, and Cempra is advancing CEM-102 in a proprietary dosing regimen to address the resistance issues we are seeing in both hospital and community settings today.”