Shares of Cempra Inc. (NASDAQ: CEMP) saw an incredible gain on Friday after the company announced the results from its late-stage trial for the treatment of patients with acute bacterial skin and skin structure infections. Overall, fusidic acid was well tolerated in the study and achieved both primary and secondary endpoints.
Over the past 52 weeks, excluding Friday’s move, Cempra’s stock is down 82%. This late-stage win is incredibly welcome at the company and could be the driving force for a turnaround.
The Phase 3 trial results demonstrated non-inferiority (NI) (10% NI margin) of oral fusidic acid compared to oral linezolid for early clinical response (ECR) in the intent to treat (ITT) patient population.
The primary endpoint, ECR in the ITT population, was defined in the study as the proportion of patients alive and achieving over 20% reduction from baseline in lesion size at 48 to 72 hours after the start of study drug, without receiving rescue antibiotics.
In the study, 87.2% of ITT patients receiving fusidic acid demonstrated ECR, compared to 86.6% of ITT patients receiving linezolid, demonstrating non-inferiority to linezolid.
Fusidic acid also showed comparable efficacy to linezolid in investigator-assessed clinical response in the ITT and clinically evaluable populations at end-of-treatment (EOT) and post-therapy evaluation (7 to 14 days post-EOT) visits.
William O’Riordan, M.D., chief medical officer of eStudySite, commented on the results:
Considering complicated skin infections are one of the most rapidly growing reasons for hospitalizations and emergency department visits each year, the results with fusidic acid in this study are promising, especially for an outpatient population where there is a need for new oral drugs that are effective against MRSA.
Cempra plans to submit the full data from this study for presentation at an upcoming scientific forum. The firm is also looking forward to meeting with the U.S. Food and Drug Administration (FDA) to discuss the next steps required to bring fusidic acid to patients in the United States.
Shares of Cempra were trading up 37% at $4.32 on Friday, with a consensus analyst price target of $10.58 and a 52-week trading range of $2.55 to $26.95.