January 19, 2010
Cempra Completes Enrollment of Phase 2 Portion of Phase 2/3 Clinical Trial of TAKSTA(TM) (CEM-102 or Sodium Fusidate) for Treatment of Acute Bacterial Skin and Structure Infections
CHAPEL HILL, N.C., Jan. 19 /PRNewswire/ -- 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."
About Cempra Pharmaceuticals
Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical company focused on developing antibacterials to address critical medical needs. Two lead products, both in late-stage clinical trials, address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is well-funded and is committed to developing commercially and medically differentiated and novel products that reduce development risk and provide a high financial return. The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders. Additional information about Cempra can be found at www.cempra.com.
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SOURCE Cempra Pharmaceuticals Inc.