Tag Archives: Phase 2 clinical trial ridinilazole

Ridinilazole Compared With Vancomycin For Efficacy and Safety For Treatment of C. difficile Infection; A Phase 2 Randomized,Double-Blind,Active-Controlled,Non-Inferiority Study

Article Summary:

Background

Clostridium difficile infection is the most common health-care-associated infection in the USA. We assessed the safety and efficacy of ridinilazole versus vancomycin for treatment of C difficile infection.

Methods

We did a phase 2, randomized, double-blind, active-controlled, non-inferiority study. Participants with signs and symptoms of C difficile infection and a positive diagnostic test result were recruited from 33 centres in the USA and Canada and randomly assigned (1:1) to receive oral ridinilazole (200 mg every 12 h) or oral vancomycin (125 mg every 6 h) for 10 days. The primary endpoint was achievement of a sustained clinical response, defined as clinical cure at the end of treatment and no recurrence within 30 days, which was used to establish non-inferiority (15% margin) of ridinilazole versus vancomycin. The primary efficacy analysis was done on a modified intention-to-treat population comprising all individuals with C difficile infection confirmed by the presence of free toxin in stool who were randomly assigned to receive one or more doses of the study drug. The study is registered with ClinicalTrials.gov, number NCT02092935.

Findings

Between June 26, 2014, and August 31, 2015, 100 patients were recruited; 50 were randomly assigned to receive ridinilazole and 50 to vancomycin. 16 patients did not complete the study, and 11 discontinued treatment early. The primary efficacy analysis included 69 patients (n=36 in the ridinilazole group; n=33 in the vancomycin group). 24 of 36 (66·7%) patients in the ridinilazole group versus 14 of 33 (42·4%) of those in the vancomycin group had a sustained clinical response (treatment difference 21·1%, 90% CI 3·1–39·1, p=0·0004), establishing the non-inferiority of ridinilazole and also showing statistical superiority at the 10% level. Ridinilazole was well tolerated, with an adverse event profile similar to that of vancomycin: 82% (41 of 50) of participants reported adverse events in the ridinilazole group and 80% (40 of 50) in the vancomycin group. There were no adverse events related to ridinilazole that led to discontinuation.

Interpretation

Ridinilazole is a targeted-spectrum antimicrobial that shows potential in treatment of initial C difficile infection and in providing sustained benefit through reduction in disease recurrence. Further clinical development is warranted.

Funding

Wellcome Trust and Summit Therapeutics.

To read the article in its entirety, please click on the following link:

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(17)30235-9/fulltext

Dr Richard J Vickers, PhD'Correspondence information about the author Dr Richard J Vickers
Glenn S Tillotson, PhD

,

Richard Nathan, MD

,

Sabine Hazan, MD

,

John Pullman, MD

,

Christopher Lucasti, DO

,

Kenneth Deck, MD

,

Prof Bruce Yacyshyn, MD

,

Benedict Maliakkal, MD

,

Yves Pesant, MD

,

Bina Tejura, MD

,

Prof David Roblin, FRCP

,

Prof Dale N Gerding, MD

,

Prof Mark H Wilcox, MD

for the

See appendix for full details of the CoDIFy study group
Published: 28 April 2017
Open Access Article has an altmetric score of 76

Open access funded by Wellcome Trust

Summit Therapeutics PLC Is Granted A “Composition Of Matter” Patent By U.S. Patent and Trademark Office

In The News:

C. difficile Infection–  Treatment On The Horizon

Summit Therapeutics PLC

summit

The US patent and trademark office have granted a “composition of matter” patent.

It gives a period of exclusivity for ridinilazole in the United States until at least December 1, 2029, with the possibility of being extended.

It’s been a busy period for the firm and Glyn Edwards, Chief Executive said: “This new patent grant in one of our potential major commercial markets substantially strengthens our intellectual property estate protecting our novel CDI antibiotic ridinilazole and supports our efforts to maximize the potential of this promising compound.”

“We are focused on our CDI and DMD programmes and today’s news, combined with the recently announced expansion advancing  of our PhaseOut DMD trial, highlights their continuing excellent progress as we seek to have a meaningful impact on the lives of patients living with these serious diseases.”

In a Phase 2 clinical trial, ridinilazole showed statistical superiority over vancomycin – the standard of care medicine –  in rates of sustained clinical response, an endpoint that captures both initial cure and recurrence of the disease.

 

To read article in its entirety:

http://www.proactiveinvestors.co.uk/companies/news/125364/summit-therapeutics-plc-boosted-by-us-patent-for-c-diff-antibiotic-125364.html

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.