Enrollment of Phase 2 portion of Cempra Pharmaceuticals' Phase 2/3 clinical trial of TAKSTA completed

Jan 19 2010

Cempra Pharmaceuticals today announced completion of enrollment of the Phase 2 portion of its Phase 2/3 clinical trial of TAKSTA (sodium fusidate; CEM-102) for the treatment of acute bacterial skin and skin structure infections.  

The Phase 2/3 trial uses an adaptive-design in which the Phase 2 portion enrolled 180 patients with acute cellulitis or wound infections into one of the three arms: a conventional twice daily TAKSTA regimen, a novel loading-dose TAKSTA regimen, or linezolid twice-daily.  Treatment in all three arms was administered for 10 to 14 days.  The Phase 2 portion of the trial will provide predictive probabilities of non-inferiority of TAKSTA to linezolid in the Phase 3 portion of the trial.  The adaptive trial design enables Cempra to transition seamlessly to the Phase 3 portion of the trial after completion of the Phase 2 portion.

Sodium fusidate is an antibiotic with an established record of treating staphylococcal infections, including methicillin-resistant S. aureus (MRSA), outside the U.S.  Its unique mechanism of action makes cross resistance with other antibiotics unlikely.  TAKSTA is being investigated with a proprietary PK-PD-based dosing regimen that is expected to optimize efficacy.

"Enrollment in our clinical trial was significantly faster than expected, which underscores the need for orally-administered agents that are effective against drug-resistant S. aureus, including MRSA, and are safe and well-tolerated by patients," said J. Gordon Still, M.D., Ph.D., Chief Medical Officer of Cempra Pharmaceuticals. "Because of the adaptive design incorporated into our clinical program we anticipate the start of the Phase 3 portion of this clinical trial shortly and we expect to complete enrollment by the end of 2010.  We also look forward to presenting the results of the Phase 2 portion at an upcoming medical conference."

Dr. Fernandes added, "Resistance to many older oral therapies has increased.  Several of the newer agents are IV only and sodium fusidate has been used to treat MRSA infections outside the U.S. for many years.  Doctors need additional oral treatment alternatives."