The growing prevalence of drug-resistant bacteria means a rise in so-called superbugs with no antibiotics to treat them. Cempra Pharmaceuticals aims to bring new antibacterial weapons to that fight.
The Chapel Hill, North Carolina-based pharmaceutical company has two clinical-stage drug candidates, including one for MRSA infections, that would each address the growing problem of antimicrobial resistance.
Cempra, founded in 2006, has raised $78 million in venture capital to date, including a $46 million series C round in 2009. The company’s financial backers include Intersouth Partners, Quaker BioVentures, Aisling Capital, Teachers Private Capital and Devon Park Bioventures.
Now, Cempra is weighing options that include another venture round, or perhaps a partnership with a large pharmaceutical company.
CEO Prabhavathi Fernandes is leaning toward landing drug partners who could take Cempra’s compounds through late-stage clinical testing and ultimately commercialization. Most large pharmaceutical companies have cut back on their antibacterial programs, explained Fernandes, herself a big pharma veteran having held leadership posts at companies such as Bristol-Myers Squibb (NYSE:BMY) and Abbott Laboratories (NYSE:ABT).
Because antibacterials lose their effectiveness as bacteria become resistant, new antibacterials must be developed every seven years or so. The pharmaceutical companies need to get them from somewhere and some will look at companies like Cempra.
“We know big pharma will come back,” Fernandes said. “They always do.”
The world market for anti-infectives — which includes antifungals, antibacterials and antivirals — totaled $24.5 billion in 2009, according to Kalorama Information. Antibacterial drugs represent almost half of the anti-infectives market.
Cempra’s research focuses on macrolides, a class of compounds that have produced effective antibiotics against a range of noninfectious diseases. The company has a macrolide library of more than 500 compounds. Cempra’s lead antibiotic candidate is being developed to fight skin problems such as MRSA infections (Methicillin-resistant Staphylococcus). The compound CEM-102, also called Taksta, is an oral drug that has shown an ability to fight a broad range of strains.
The compound is already approved for use in Europe and several other global markets. Cempra has exclusive U.S. rights. Fernandes estimates that phase 3 trials will cost $60 million. Trials could start within six months of securing funding.
The other clinical-stage compound, CEM-101, or solithromycin, is entering phase 2 trials as a treatment for community-acquired bacterial pneumonia. Solithromycin is expected to have a broad spectrum of activity including Legionnaires’ disease, as well as sexually transmitted diseases such as syphilis.
Solithromycin is being developed for both oral and intravenous administration. Fernandes said that some pharma companies have expressed interest in that compound. She has asked them to wait until mid-stage studies are completed.
Cempra’s macrolide library has nonantibacterial candidates with the potential to address indications such as inflammatory and endocrine disorders. But the company’s emphasis so far has been on developing superbug-fighting antibacterials. It’s a market in constant need of new products because of growing antibacterial resistance, Fernandes said.
“Any true microbiologist will tell you you’ll get resistance over time,” she said. “Maybe it will be 10 years. Maybe it will be 12 years.”