Summit Awarded Additional US$12 Million from BARDA

On Thursday (August 16), Summit Therapeutics (NASDAQ:SMMT, LSE:SUMM) was awarded an additional US$12 million bringing its total to US$44 million in gross committed funding from a Biomedical Advanced Research and Development Authority (BARDA) contract.

This funding will support Summit’s Phase 3 development program for ridinilazole, a precision mechanism antibiotic to treat C. difficile infection (CDI).

“BARDA’s continued support underlines the promise ridinilazole has as a potential front-line CDI treatment option which can treat the initial infection and address the key clinical issue of recurrent disease,” Glyn Edwards, CEO of Summit said in the press release.

Edwards added the planned initiation of this trial is on track to begin in Q1 2019.

The added funding is specifically to support drug manufacturing activities required for the submission of marketing approval applications and other regulatory activities.

The other awarded base package amount for Summit from BARDA was announced in September 2017. The organization may exercise remaining options to award further funding to Summit Therapeutics which could reach US$62 million.

CDI is increasingly becoming a wider threat in communities, but has longer been an issue in hospitals and long-term care homes. There are about one million cases of CDI in the US and Europe, and approximately 14,000 deaths per year in the US..

The disease is caused by an infection in the colon by the bacteria C. difficile causing inflammation and severe diarrhea, which can be fatal. Existing treatments are mainly antibiotics which disrupt or damage the natural gut flora of patients and are associated with a high rate of recurrence of the disease.

Ridinilazole is a small molecule antibiotic received Qualified Infectious Disease Product designation and has been granted Fast Track designation by the US Food and Drug Administration (FDA).

In its Phase 2 clinical trial, the drug showed statistical superiority in sustained clinical response (SCR) compared to the current standard of care, vancomycin. The SCR which was defined as a cure because it treated and resulted in no recurrence of CD in  patients within 30 days of the end of therapy.

BARDA is part of the HHS Office of the Assistant Secretary for Preparedness and Response. In addition to supporting clinical trials, it also supports vaccine and diagnostic from research.

Other support includes technical assistance, and core services ranging from a clinical ranging from a clinical research organization network to Centers for Innovation in Advanced Development and Manufacturing, and a fill-finish manufacturing network.

Summit Therapeutics is working to be a leader in antibiotic innovation through its new mechanism antibiotics using its Discuva Platform to expand its pipeline.

Investor takeaway

Over Thursday’s trading period, Summit’s stock price increased 5.13 percent to close the session at US$2.15.

TipRanks shows one analyst, Arlinda Lee with Canaccord Genuity reiterated a “Buy” target for the company on Thursday with a US$3 price target.

Keen investors can follow Summit’s news and look forward to hearing about this Phase 3 clinical trial with ridinilazole in Q1 2019.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.