Tag Archives: CDI clinical trials

MGB Biopharma Presented Data In Pre-IND Meeting With FDA With A Proposal For Further Clinical Development Of Oral MGB-BP 3, A Truly Novel Antibiotic Addressing Clostridium difficile (C. diff. )

MGB Biopharma, a biopharmaceutical company developing a truly novel class of anti-infectives to address the major global problem of antibiotic resistance, announces that it has held a pre-Investigational New Drug (pre-IND) meeting with the Food and Drug Administration (FDA) to discuss the regulatory strategy for the development programme of MGB-BP-3 in the US.

MGB Biopharma presented available Phase I and pre-clinical data together with a proposal for the further clinical development of oral MGB-BP-3 in Clostridium difficile infections (CDI). Following this positive meeting, MGB Biopharma are now in the process of obtaining a designation of Qualified Infections Disease Product (QIDP) status for MGB-BP-3, and are starting to prepare for the clinical Phase II study.

MGB-BP-3 is an antibiotic that has shown to be active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a Gram-positive bacterium responsible for the majority of infectious hospital-acquired diarrhoea in developed countries.

Successful completion of the clinical Phase I study confirmed MGB-BP-3 was well tolerated in healthy volunteers, was not systemically absorbed, had no effect on intestinal permeability, and had a noted effect on the Clostridium class of normal gut flora.

Dr Miroslav Ravic, CEO of MGB Biopharma, said: “We are extremely pleased with the support we have received from the FDA with regards to our plans to further progress the clinical development of oral MGB-BP-3. We are now planning to initiate a Phase II clinical trial and investigate the safety and efficacy of MGB-BP-3 in patients with CDI, caused by the most virulent ribotype of C. difficile known as C. difficile B1/NAP1/027. This ribotype is shown to cause the highest morbidity and mortality in CDI patients, where the current therapy has only moderate efficacy.”

Dr Ravic added: “Our discussions with the FDA have provided clear guidelines on the development path we need to take to bring our truly novel antibiotic MGB-BP-3 to market in the shortest possible time. In parallel with our clinical development activities we are now evaluating partnering and funding sources for this exciting opportunity, which we believe will offer a clearly differentiated treatment option for patients with life threatening infections caused by resistant Clostridium difficile.”

C. difficile (CDI) Treatment Summit Therapeutics Has Reported Outstanding Results In the Phase II Trial of Ridinilazole

Summit Therapeutics  has reported ‘outstanding’ results in the phase II trial of ridinilazole, its new C.difficile (CDI) treatment.

During the trial, the new oral antibiotic significantly outperformed vancomycin, the current standard prescription, which was the primary objective said Summit.

Over two-thirds (66.7%) of those treated showed a sustained clinical response (SCR) against 42.4% for vancomycin.

The statistical superiority was driven by a large numerical reduction in recurrent disease compared with vancomycin, which Summit said was key as recurrence is one of the hardest things to stop.

C.difficile or CDI is a growing danger for patients in hospital, care homes and the wider community.

Annually, there are between 450,000 and 700,000 cases in the US alone, with the elderly and sick especially vulnerable.

One study has suggested it costs US$4.8bn to treat these people.

“The healthcare community is acutely aware of the major threat CDI poses, particularly given widespread antibiotic use and our aging population,” said Glyn Edwards, Summit’s chief executive.

The biggest unmet need in CDI treatment is reduce recurring cases, he added and the results from the latest trial had exceeded its ‘wildest expectations’.

“These outstanding clinical data from CoDIFy strongly support the profile of ridinilazole as a narrow spectrum antibiotic.

“There is a vital need for potent new antibiotics, and the potential of ridinilazole has attracted great interest.

Edwards added that the results from the CoDIFy trial were exceptionally encouraging and the aim no is to advance ridinilazole into Phase 3 clinical trials.

Here, the company would evaluate partnership opportunities against the benefit of it forward itself, he added.

Professor Mark Wilcox, at Leeds University and Public Health England’s lead consultant on C.difficile added that the latest data indicated ridinilazole could become an important new treatment option for CDI with the potential to reduce the high rates of recurrent disease that remain a key clinical challenge.

CoDIFy was a double blind, randomised, active controlled, multicentre, Phase II clinical trial that evaluated the efficacy of ridinilazole against vancomycin in 100 patients in the US and Canada.

Results from a second CoFIFy trail are due next year, though Edwards said the results announced today would provide the bulk of the quantitative data.

Ridinilazole has already received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration

 

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