TIDMDEST
RNS Number : 1672L
Destiny Pharma PLC
12 May 2022
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, 30(th)
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 fidaxomicin(3)
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."
END
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO / Shaun Claydon, CFO
+44 (0)1273 704 440
pressoffice@destinypharma.com
Optimum Strategic Communications
Mary Clark / Manel Mateus / Vici Rabbetts
+44 (0) 208 078 4357
DestinyPharma@optimumcomms.com
finnCap Ltd (Nominated Advisor and Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate
Finance
Alice Lane / Nigel Birks / Harriet Ward, ECM
+44 (0) 207 220 0500
MC Associates AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-0
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
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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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