Last checked at 12 May 2022 07:00
Destiny Pharma plc
("Destiny Pharma" or "the Company")
World leading C. difficile scientists to present landmark data on the ability of NTCD-M3 to colonise the gut after antibiotic administration
Brighton, United Kingdom - 12 May 2022 - Destiny Pharma (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces that data generated from a recent C. difficile infection (CDI) model study, on the ability of non-toxigenic C. difficile strain M3 (NTCD-M3) to successfully colonise the gut following administration of antibiotics, has been accepted for presentation at the prestigious Anaerobe 2022 Conference in Seattle, WA, US on Saturday, 30th July 2022.
As previously reported, a Phase 2 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 from 30% in placebo to 5% in treated patients. Patients received either vancomycin or metronidazole to treat the initial toxic C. difficile infection before receiving NTCD-M3 treatment.[1] Since the end of this trial, a new antibiotic, fidaxomicin, has been added to US clinical guidelines for treating CDI[2]. It is known that fidaxomicin3 resides for a longer period within the gut potentially inhibiting the colonisation by bacteria such as NTCD-M3. This latest study by the Microbiology Research Laboratory at the Edward Hines, Jr. VA Hospital in the US sought to address this question by monitoring the colonisation of NTCD-M3 in an established CDI model following administration of fidaxomicin.
In summary, this study conducted in the lab of the authors at the Edward Hines, Jr. VA Hospital, clearly demonstrated that NTCD-M3 was able to effectively 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.
Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said: "The relevance and impact of this study cannot be underestimated as it indicates that the clinical use of fidaxomicin to treat CDI is unlikely to affect the ability of Destiny's late-stage asset, NTCD-M3, to colonise the gut and prevent recurrence of CDI. This is important as fidaxomicin has recently been added to the recommended guidelines for treatment of CDI in the US, and the use of this new antibiotic is growing. We therefore remain confident that our groundbreaking NTCD-M3 live biotherapeutics product can be used alongside all currently recommended antibiotics in the treatment of this serious hospital infection."
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About Destiny Pharma
Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF research projects.
For further information, please visit https://www.destinypharma.com
About NTCD-M3
NTCD-M3 is a novel microbiome therapeutic being developed to reduce the recurrence of C. difficile infections in the gut. CDI is the leading cause of hospital-acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year.
NTCD-M3 has the potential to become the leading treatment for CDI prevention, as its Phase 2 data demonstrated a class leading 5% rate of recurrence compared to 30% with placebo.
The benefits of NTCD-M3 include:
• Single bacterial strain: a naturally occurring, single strain of a non-toxigenic bacteria
• Excellent safety profile: well-defined treatment
• Strong clinical data: NTCD-M3 recurrence rate of 5% versus 30% with placebo, which is "class leading"
• Convenient treatment option: complementary to all current standard of care antibiotic treatments, administered as a single capsule once daily for seven days
• Well-established manufacturing: will be manufactured at high volume and low cost with a long shelf life which should enable high uptake and a strong pharmacoeconomic position
Forward looking statements
Certain information contained in this announcement, including any information as to the Group's strategy, plans or future financial or operating performance, constitutes "forward-looking statements". These forward looking statements may be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "anticipates", "projects", "expects", "intends", "aims", "plans", "predicts", "may", "will", "seeks" "could" "targets" "assumes" "positioned" or "should" or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group's results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the company believe that the expectations reflected in these statements are reasonable, but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group's control. Forward looking statements are not guarantees of future performance. Even if the Group's actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods.
[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.