Landmark data published on NTCD-M3

RNS Number : 2223V

Destiny Pharma PLC

04 April 2023

 

Destiny Pharma plc

("Destiny Pharma" or "the Company")

Landmark data published on successful NTCD-M3

gut colonisation after fidaxomicin administration

Brighton, United Kingdom - 4 April 2023 - 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 C. difficile infection (CDI) model study on the ability of M3 (NTCD-M3), a non-toxigenic C. difficile strain, to successfully colonise the gut following administration of fidaxomicin has been peer-reviewed and published in Microbiology Spectrum

 ( https://journals.asm.org/doi/10.1128/spectrum.00517-23 ).

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 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 treatment[1]. Since the end of this trial, fidaxomicin, a new antibiotic, has been added to US clinical guidelines for treating CDI[2]. 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 landmark 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.

In summary, the paper 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.

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 groundbreaking live biotherapeutics product can be used alongside all currently recommended antibiotics in the treatment of this serious hospital infection."

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Destiny Pharma plc
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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.

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[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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