Cempra touting positive antibiotic results
- North Carolina-based anti-infectives company Cempra is celebrating positive news for a Phase 3 trial of its fungal-derived antibiotic, Taksta (fusidic acid), as an oral treatment for acute bacterial skin and skin structure infections (ABSSSI).
- Fusidic acid, which has been available since the 1960s in various forms, hit the primary endpoint – non-inferiority to linezolid – in key pathogens, including MRSA when given orally as a high loading dose, followed by a lower dose every 12 hours over ten days.
- The treatment-emergent adverse event rates were also similar between the two groups. Cempra's shares leapt by 38% at the news to trade above $4 per share.
Skin and soft-tissue infections, which range from unpleasant to life-threatening, are a common reason behind requests for antibiotics. They can be community- or hospital-acquired, and their treatment becomes complicated, lengthy and costly when methicillin-resistant Staphylococcus aureus (MRSA) is involved.
Fusidic acid has been used for decades as an antibiotic, orally, intravenously and topically, but there is a risk of development of resistance at low doses, meaning that is has to be used with other antibiotics. Cempra is developing fusidic acid as a monotherapy, known as Taksta, based on findings that the risk of resistance is lowered when given at high doses, particularly with a high initial loading dose.
"We are excited that the results of this Phase 3 study with fusidic acid confirm the results of our Phase 2 study and are consistent with the more than 40 years of experience that the product has accumulated outside the United States," said David Oldach, CMO of Cempra. "We look forward to meeting with the FDA to discuss the next steps required to bring fusidic acid to patients in the United States."
Cempra has a lot riding on the success of fusidic acid after the receipt of a complete response letter for oral and intravenous Solithera (solithromycin) from the FDA at the end of December 2016. This required more clinical safety information from a much larger safety study, as well as correction of deficiencies in inspections at Wockhardt and Hospira.
The drug is pending approval in both the U.S. and Europe for the treatment of community-acquired bacterial pneumonia (CABP). Cempra also had a short-notice change of leadership last December, with the retirement of CEO and co-founder Prabha Fernandes. She was replaced by David Zaccardelli as acting chief on an extendable three-month contract.
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