Landmark trial data on successful gut colonisation

Gut microbiome

Data generated from a C. difficile infection (CDI) model study on the ability of M3 (NTCD-M3), a non-toxigenic C. difficile strain, shows successful gut colonisation following administration of fidaxomicin and has been peer-reviewed and published in Microbiology Spectrum.

The paper by Destiny Pharma, a UK-based clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, concludes that NTCD-M3 is able to effectively and fully colonise the gut following fidaxomicin administration, indicating that NTCD-M3 would be effective in patients receiving this antibiotic, as well as older antibiotics, such as vancomycin and metronidazole.

Study findings

As previously reported, a Phase II clinical trial in patients suffering CDI demonstrated that administration of NTCD-M3 shortly after the use of antibiotics to treat the initial infection, successfully reduced recurrence of CDI from 30% in placebo to 5% in treated patients. Patients had received either vancomycin or metronidazole to treat the initial toxic C. difficile infection before receiving NTCD-M3 treatment1.

Since the end of this trial, fidaxomicin, a new antibiotic, has been added to US clinical guidelines for treating CDI2. It is known that fidaxomicin, and especially its active metabolite3, reside within the gut for longer, potentially inhibiting colonisation by bacteria such as NTCD-M3.

This publication, from research completed by the Microbiology Research Laboratory at the Edward Hines, Jr. VA Hospital in the US, has addressed this question by monitoring the colonisation of NTCD-M3 in an established and highly translatable CDI model following administration of fidaxomicin.

Official comments

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said: “This publication, authored by leading US CDI expert Dr Stuart Johnson, is a landmark for NTCD-M3, as the use of fidaxomicin is growing and it has recently been recommended by guidelines as the first choice for treatment of CDI in the US. This demonstration of successful and complete colonisation of the gut by NTCD-M3 post‑fidaxomicin, confirms that this ground-breaking live biotherapeutics product can be used alongside all currently recommended antibiotics in the treatment of this serious hospital infection.”

References

  1. Gerding et al. Administration of Spores of Nontoxigenic Clostridium difficile Strain M3 for Prevention of Recurrent C difficile Infection A Randomized Clinical Trial. JAMA May 5, 2015 Volume 313, Number 17.
  2. Johnson, et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. 73(5), pp.e1029–e1044.
  3. Shue YK et al Safety, Tolerance, and Pharmacokinetic Studies of OPT-80 in Healthy Volunteers following Single and Multiple Oral doses Antimicrob Agents Chemother 2008;52:1391-5. Stool drug levels well above MIC of C difficile at 5 days post single dose of 200 or 300 mg.

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