Cempra, Inc., announced that it has completed its rolling submission of a New Drug Application for solithromycin, a potential treatment for community-acquired bacterial pneumonia (CABP), to the U.S. Food and Drug Administration.
The FDA has already granted solithromycin, a type of antibiotic, Fast Track designation for both its oral capsule and intravenous formulations, and a decision on the drug application is possible in late 2016, Cempra said. The agency has a 60-day filing review period to determine if the application is complete and to confirm if it will be given priority review.
Solithromycin is a next-generation macrolide, the first fluoroketolide, active against most macrolide-resistant strains. In vitro and in vivo studies have demonstrated potent activity against S. pneumoniae, and an extended spectrum of activity against CA-MRSA, streptococci, Haemophilus, Enterococci, Mycobacterium avium, and in animal models of malaria.
Positive topline results from a global and pivotal Phase 3 clinical trial of intravenous and oral solithromycin (Solitaire-IV) in 863 patients with moderate to moderately severe CABP were announced by the company in October 2015. An earlier Phase 3 trial likewise reported positive results.
“The management of CABP remains a challenge to healthcare professionals and I firmly believe that solithromycin has the potential to be a significant part of the treatment of this life threatening illness, given its published clinical efficacy and potential for multiple formulations,” Thomas M. File, MD, the principal investigator for the clinical trials, said in a press release. “Solithromycin’s potency, spectrum of activity and tolerability could help to offset the rising problem of bacterial resistance, and it is gratifying to note that patients could be closer to benefiting from this potential new treatment.”
Solithromycin is eight to 16 times more potent than azithromycin against many bacteria, and is also active against azithromycin-resistant strains due to its ability to interact with three sites on the bacterial ribosome, compared to one for current macrolides. The development of bacterial resistance to solithromycin is also expected to be limited by the binding to bacterial ribosomes and interaction with three ribosomal sites. The drug candidate has also demonstrated activity against atypical bacteria (legionella, chlamydia, mycoplasma, and ureaplasma), and against gonococci and other genitourinary tract infection-causing organisms.
“Completion of the rolling submission of our first NDAs during Cempra’s ten year anniversary year represents a major milestone for the company and a significant step toward our goal of developing antibiotics to meet the critical medical needs of patients in the treatment of bacterial infectious diseases,” said Prabhavathi Fernandes, president and chief executive officer of Cempra. “We believe the intravenous and capsule formulations will provide dosing flexibility that could lead to fewer hospital admissions, earlier discharge if admitted, and increased treatment of CABP on an outpatient basis. We are confident we have a strong data package for solithromycin.”