From Cempra’s (NASDAQ:CEMP) earliest days, overcoming drug resistance has been CEO Prabhavathi Fernandes’s rallying cry for developing novel antibacterials to fight infection.
In awarding Cempra a federal contract valued at up to $58 million, the Biomedical Advanced Research and Development Authority expressed interest in antibacterial agents that overcome a possibly more serious danger — terrorist tinkering that can turn dangerous pathogens into deadly drug resistant bioweapons.
If Fernandes is confident terrorists won’t succeed in engineering a pathogen that’s resistant to Cempra’s solithromycin, perhaps it’s because Cempra has already tried.
“When we have tried to do this in the lab, that bug is so sick that it’s no longer virulent,” she told analysts on a conference call Wednesday. “In a lot of cases it’s no longer viable.”
A day after announcing the $58 million BARDA contract, Fernandes held court with analysts who largely praised the company for its recent wins regarding its antibacterial candidate solithromycin. Besides the BARDA contract, Cempra earlier this month announced a deal with Japanese firm Toyama Chemical Co. valued at up to $70 million. Toyama is interested in developing and commercializing solithromycin in Japan.
Solithromycin is Cempra’s antibacterial candidate that the company is studying in phase III clinical trials as a treatment for community-acquired bacterial pneumonia, or CAPB, in adults. But the compound has shown a broad spectrum of activity and BARDA is interested in its potential to treat infections in children as well as thwart bioterror threats.
In Cempra’s tests so far, solithromycin has shown itself to be effective throughout the body, even in places where bacteria may linger and escape other antibiotics. Not only has the compound shown a broad spectrum of activity, it has also shown what Fernandes characterized as the “the right spectrum of activity.” It doesn’t wipe out the bacteria in the body that’s beneficial, such as gut flora. That’s a particularly important attribute for a pediatric population.
“It preserves what is good for us and gets what’s bad for us,” Fernandes said. “This is the day we realize we cannot cause harm while doing good.”
Cempra is guaranteed $17.7 million over two years, which will be used for clinical trials in children. The funding will also pay for studies of solithromycin’s effectiveness against anthrax and tularemia, two diseases that are potential bioterror threats. Bioterror agents aren’t tested in humans. Animal tests are sufficient to test countermeasures to these pathogens under FDA’s animal efficacy rule.
If Cempra’s solithromycin is approved, it could become the first new oral antibiotic since azithromycin in 1991. Fernandes said solithromycin fills a need because most of the antibiotic candidates in development for use in hospitals, administered to adults intravenously.
“There are no antibiotics in development that we are aware of that can be used orally and also have the potential for broad application in pediatric and special populations,” she said.
Cempra will be conducting the studies of solithromycin in adults concurrently with the pediatric studies. Adult approval is needed in order to get pediatric approval and Fernandes said that there will be some overlap in the programs. But she emphasized that they are separate programs and the BARDA funding will be applied to the pediatric clinical trials and the bioterror studies.
Fernandes declined to attach figures to the market opportunity for a biodefense antibacterial. She said she hopes there’s no opportunity for that application.
“It’s just like buying life insurance, you hope you never have to use it,” she said. “If they do (attack), it’s to make sure we have something.
