With $62M BARDA Contract Secured, the Future for Summit’s Ridinilazole Looks Bright

Summit Therapeutics has achieved a significant step toward initiating its clinical research program just seven months after outlining plans for Phase III trials for its developmental Clostridium difficile antibiotic, ridinilazole, after receiving a contract worth $62 million from the US government's Biomedical Advanced Research and Development Authority (BARDA). With this information, the company appears well-positioned to begin Phase III trials in the first half of 2018, establishing ridinilazole as the second-most advanced CDI development antibiotic after Actelion's cadazolid.

Healthcare-acquired infections (HAIs) known as Clostridium Difficile Market can cause diarrhea and, in severe cases, necessitate surgical intervention. One study estimates that CDIs are now the most common HAI in the United States due to the emergence of hypervirulent CDI strains in the early 2000s. Patients are at risk of recurrence despite the fact that current treatment options, such as oral vancomycin, are thought to be effective at controlling the infection. Because of the huge neglected need inside this illness region, the market size for CDI is set to develop over the course of the following 10 years, and a new report by GlobalData predicts that the worldwide market for CDI therapeutics will arrive at $1.7B by 2026, addressing a Build Yearly Development Rate (CAGR) of 10.2% throughout this time span.

Culmination Therapeutics' ridinilazole is a pipeline anti-microbial that is being created to diminish the gamble of contamination repeat in CDI patients. Ridinilazole is a first-in-class anti-toxin that is profoundly particular toward C. difficile. Clinical examinations have shown that patients getting ridinilazole to treat a CDI experience less inadvertent blow-back to their normal stomach microbiota, which Highest point Therapeutics accepted would assist with decreasing the possibility growing further repeats. During the Phase II trials for ridinilazole, which found that patients taking ridinilazole had a lower rate of infection recurrence than those taking vancomycin, this theory appeared to translate well into clinical practice.

In the CDI market, the development antibiotic cadazolid from Actelion and the current antibiotic Dificid (fidaxomicin) from Merck & Co. are the main competitors for ridinilazole. Phase III trials for Cadazolid were scheduled to conclude this year; However, Actelion made the announcement in June that one of the drug's two Phase III trials had failed to meet its primary endpoint, and it is now unclear how the company intends to proceed with development going forward. Dificid, which was introduced by Merck & Co. in 2011, is marketed as an alternative to vancomycin for the treatment of CDIs and promises higher rates of recurrence. Dificid, on the other hand, has not been able to establish a significant foothold in the CDI market due to concerns raised by physicians regarding the treatment's high cost and questionable efficacy, which resulted from the use of non-inferiority trials during Phase III development.

Summit will investigate ways to give ridinilazole a competitive advantage over Dificid and cadazolid in both clinical and commercial settings. The company has already stated that the primary endpoint of the Phase III trials will be superiority to vancomycin rather than non-inferiority criteria used in rival clinical trials. When choosing a pricing strategy for ridinilazole, it will likely also closely examine Merck's experience with Dificid, which is typically regarded as being too expensive by physicians. The product's fate could be decided by Summit's ability to position ridinilazole as an improvement over vancomycin through the use of cost-effectiveness.