The federal faucet is opening again to pour $25.5 million into solithromycin, a promising drug being developed by Cempra, a Chapel Hill company that has declared war on bacterial infections.

Cempra is now authorized to receive the $25.5 million as part of its contract with the federal Biomedical Advanced Research and Development Authority (BARDA) to develop solithromycin for pediatric use. Three formulations — intravenous, oral capsules and a suspension formulation – are in a phase one-b trial in children from two months to 17 years of age.

Next-generation class of drugs

Solithromycin is a next-generation macrolide, a class of drugs – mostly antibiotics – whose activity stems from a macrolide ring in their molecular structure. Cempra says solithromycin is active against macrolide-resistant bacteria and is more active than azithromycin or clarithromycin against most macrolide-susceptible bacteria.

In January, Cempra, a 10-year-old clinical-stage company publicly traded on the NASDAQ stock exchange, announced plans to raise up to $201 million in a public stock offering.

Cempra is using some of the proceeds of that stock sale to fund the commercial launch of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in the United States, subject to approval by the Food and Drug Administration.

Lots of uses for solithromycin

Solithromycin has successfully completed two phase three clinical trials for CABP and is licensed to strategic commercial partner Toyama Chemical Co., a subsidiary of FUJIFILM Holdings Corp., for certain exclusive rights in Japan. Solithromycin is also in a phase three clinical trial for uncomplicated urogenital urethritis caused by gonorrhea or chlamydia.

Cempra is also using proceeds from the stock sale to continue the clinical and regulatory development of its second lead product candidate, TAKSTA (sodium fusidate), for the treatment of acute bacterial skin and skin structure infections.

The company says both solilthromycin and TAKSTA address the growing problem of antimicrobial drug resistance, which increases patient morbidity and mortality and raises healthcare costs globally. The World Health Organization has identified antibiotic resistance as one of the greatest healthcare challenges for the future.

TAKSTA has a long history of safety and efficacy outside the United States. It is active against gram-positive pathogens, including both hospital- and community-acquired methicillin-resistant S. aureus.

Cempra has also synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders.

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