REG - Destiny Pharma PLC - Landmark data published on NTCD-M3

Destiny PharmaAnnouncement

04/04/2023 07:00

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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
(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  (#_ftn1) . Since the end of
this trial, fidaxomicin, a new antibiotic, has been added to US clinical
guidelines for treating CDI 2  (#_ftn2) . It is known that fidaxomicin, and
especially its active metabolite(3), 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."

 

END

 

 

 

 

 

 

For further information, please contact:

 

Destiny Pharma plc
Neil Clark, CEO

Shaun Claydon, CFO

+44 (0)1273 704 440
pressoffice@destinypharma.com (mailto:pressoffice@destinypharma.com)

 

Optimum Strategic Communications
Mary Clark / Nick Bastin / Jonathan Edwards / Eleanor Cooper

+44 (0) 7931 5000 66
DestinyPharma@optimumcomms.com (mailto:destinypharma@optimumcomms.com)

 

finnCap Ltd (Nominated Advisor and Joint Broker)
Geoff Nash / George Dollemore, Corporate Finance

Alice Lane / Nigel Birks / Harriet Ward, ECM

+44 (0) 207 220 0500

 

Shore Capital (Joint Broker)

Daniel Bush / James Thomas / Lucy Bowden

+44 (0) 207 408 4090

 

MC Services AG
Anne Hennecke / Andreas Burckhardt

+49-211-529252-12

 

Stern IR - US

Janhavi Mohite

+1-212-362-1200

janhavi.mohite@sternir.com

 

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
(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  (#_ftnref1) 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  (#_ftnref2) 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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