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Summit Therapeutics PLC presents positive CDI results

The primary analysis was conducted on the modified intent-to-treat population that comprised subjects with CDI

CDI is caused by an infection of the colon by the bacterium C. difficile

Drug development company Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) has presented positive results from a trial of its drug that combats hospital super-bug C- diff.

The company unveiled the findings from the Phase 2 CoDIFy trial highlighting the potential of ridinilazole in the treatment of clostridium difficile (CDI) infection at what is called a poster presentation, at the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

Summit said the findings include a markedly reduced recurrence rate and a statistically superior rate of sustained clinical response in patients with CDI receiving ridinilazole, compared with those receiving the standard of care, vancomycin.

Sustained clinical response is defined as clinical cure at the end of treatment and no recurrence of the condition in 30 days after therapy.

Ridinilazole is a novel class antibiotic with the potential for broad use across the CDI disease spectrum. CDI is a serious threat in hospitals and care homes and there are between 450,000 and 700,000 cases in the US annually.

"Preventing disease recurrence is a major unmet need in CDI, both for newly diagnosed patients who are receiving initial treatment and for patients who are receiving treatment for recurrent disease," said Dale Gerding, MD, Research Physician, Hines Veterans Affairs Hospital, Professor of Medicine, Loyola University Stritch School of Medicine, and an author on the presentation.

"In this context, it is very encouraging to see such a marked reduction in recurrences with ridinilazole in the Phase 2 trial," Gerding said.

Glyn Edwards, chief executive of Summit, said: “Ridinilazole's narrow spectrum of activity appeared to substantially reduce damage to the gut microbiome in the Phase 2 clinical trial, allowing patients to maintain or rebuild their natural defences against recurrence of CDI.”

Recurrence is a key problem as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.

“The wealth of data we have reported on the compound to date, including the positive efficacy results presented today at ECCMID, suggest that ridinilazole could become a truly differentiated product with potential for broad use in CDI, including front-line treatment," Edwards said.

Key efficacy findings from the trial presented at ECCMID were:

  • Statistical superiority in SCR with rates of 66.7% for ridinilazole compared to 42.4% for vancomycin

  • Marked reduction in recurrence with rates of 14.3% for ridinilazole compared to 34.8% for vancomycin

  • Cure rates at the end of treatment of 77.8% for ridinilazole and 69.7% for vancomycin

A copy of the poster is available from Summit's web site .

Earlier in the day it was revealed that Point72 Asset Management, formerly SAC Capital Advisors, has revealed it has a near 8% stake in Summit.

The investment firm has acquired American Depositary Receipts equivalent to 4.88mln ordinary shares, representing 7.96% of the issued ordinary share capital of Summit, which is advancing a treatment for Duchenne muscular dystrophy (DMD), a fatal muscle wasting disease mainly affecting boys, as well as a drug to combat CDI.

Point72 Asset Management is the investment vehicle of hedge fund billionaire Steven Cohen. It recently reopened a London office as part of its programme to re-establish its presence in Europe, having closed its London office back in 2013 during a period of retrenchment after the company agreed to pay $1.8bn in penalties relating to insider-trading violations. The company was also prevented from managing money for outside clients for a period.

According to Forbes magazine, Cohen is worth an estimated $12.7bn.

The investment in Summit held by Point72 is currently worth around £4.6mln.

Shares in Summit were trading at 95.5p in lunchtime trading, up a penny on the day.

Quick facts: Summit Therapeutics PLC

Price: 20.5 GBX

Market: AIM
Market Cap: £68.91 m

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