Cempra Pharmaceuticals, Inc. Surges as Lead Oral Antibiotic Meets Main Goal in Phase 3 Study
Published: Jan 05, 2015
January 5, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Cempra Pharmaceuticals, Inc. , saw its shares jump 24.46 percent to $28.44 in early morning trading Monday, after the company said late Sunday that its oral antibiotic showed positive results in a phase 3 clinical trial.
The antibiotic, also known as solithromycin, showed positive results when utilized in patients with community acquired bacterial pneumonia. Oral solithromycin met its primary objective, which was statistical non-inferiority of the early clinical response at 72 hours after the initiation of treatment.
"I congratulate Dr. David Oldach, senior vice president of Clinical Research, his clinical group and the entire Cempra team for running this landmark oral study which has produced these positive efficacy results for the solitaire-oral clinical trial, the first of our two pivotal Phase 3 studies for solithromycin," said Prabhavathi Fernandes, president and chief executive officer of Cempra. "The management of CABP remains a challenge for healthcare providers and I believe solithromycin has the potential to be a rational option for the treatment of this life threatening illness. Our phase 3 solitaire intravenous study continues to enroll patients as planned."
The Phase 3 trial was a double-blind, active-controlled global, multi-center trial that looked at 860 people with CABP. Patients were randomized to either receive the drug over the course of five days, or oral moxifloxacin for seven days. The most common adverse effects associated with solithromycin included headache, diarrhea, nausea and dizziness.
Increasing Resistance to Antibiotics
The success of Cempra’s oral antibiotic sheds light on growing bacterial resistance, which was also addressed in Molecular Biology and Evolution in June 2014. The online edition of the journal used an experimental evolution approach to evolve 88 E. coli populations against 22 antibiotics. The goal was to determine how effective these drugs were against the bacteria.
After 21 days, researchers measured the bacteria’s resistance to each of the 22 antibiotics. They determined that the evolution of cross-resistance was dependent on selection strength. However, they discovered that high cross-resistance was preferred in strongly selected strains.
Solithromycin, a next-generation macrolide, has shown potent activity against most macrolide-resistant strains. It is also up to 16 times more potent than azithromycin, and Cempra has plans to further study the antibiotic, which may help fight resistant bacteria in the future.