REG - Destiny Pharma PLC - Positive update from EMA on NTCD-M3 Phase 3 plans

Destiny PharmaAnnouncement

07/09/2022 07:16

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RNS Number : 5120Y  Destiny Pharma PLC  07 September 2022

Destiny Pharma plc

("Destiny Pharma" or the "Company")

 

Destiny Pharma announces positive update from European Medicine Agency (EMA)
on NTCD-M3 Phase 3 development plans

 

·      EMA endorses Destiny Pharma's proposed single pivotal Phase 3
study design for the development of NTCD-M3 for the prevention of recurrence
of Clostridioides difficile infections (CDI)

·      EMA endorses plans for the new patient-friendly NTCD-M3 capsule
formulation

 

Brighton, United Kingdom - 7th September 2022 - Destiny Pharma plc (AIM:
DEST),  a clinical stage biotechnology company focused on the development of
novel products to prevent life-threatening infections, is pleased to announce
that it has received positive feedback from the European Medicine Agency (EMA)
on the proposed NTCD-M3 Phase 3 development programme.

 

NTCD-M3 is the lead clinical candidate being developed by Destiny Pharma for
the prevention of the recurrence of infections caused by toxic strains of the
gut bacteria Clostridioides difficile, which can cause significant
inflammation and damage to the gut leading to an estimated 29,000 deaths
annually in the US alone, a number comparable to the yearly deaths from
prostate cancer. It is estimated CDI adds an extra $6 billion to US healthcare
costs per annum while in Europe, the economic burden caused by CDI is
estimated at $3 billion and increasing.

 

The key points from the EMA's feedback are that they have agreed:

 

·      With the overall comparability plans relating to the development
of the new easy-to-use capsule formulation of NTCD-M3, thus lifting any
requirements for human trials to demonstrate such comparability

·      That the proposed single trial Phase 3 design to be sufficient
for a MAA (Marketing Authorisation Application) also endorsing the primary and
secondary endpoints of the proposed Phase 3 study

·      That the overall proposed safety database will be collected
through the conduct of the proposed Phase 3 trial and that this would be
sufficient for a MAA

·      To remove the requirement of a thorough QT study (a study which
is used to measure the potential impact of a drug on the heart function) for
NTCD-M3 development programme

 

With EMA's feedback received, Destiny Pharma is now focused on finalising the
manufacturing and formulation of NTCD-M3 clinical trial material and on the
detail of the global Phase 3 study with the aim of enrolling the first patient
in the USA and potentially in Europe/rest of the world, towards the end of
2023. The Company is currently seeking partners to co-fund the Phase 3
clinical programme and take responsibility for the approval and
commercialisation of NTCD-M3.

Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, said:

"NTCD-M3 is a unique microbiome product being a single strain of non-toxigenic
Clostridioides difficile. This targeted mode of action differentiates it from
FMT (faecal microbiota transplantation) or other multiple strains or consortia
microbiome products and NTCD-M3 also has advantages from a safety and
longer-term risk perspective. Importantly, the NTCD-M3 strain only transiently
colonises the patient's intestine which means it protects from CDI while
allowing the normal microbiome to be rebuilt after antibiotic treatment.
Additionally, NTCD-M3 delivers an impressive efficacy with recurrence rates
reduced to around 5% when used immediately after the antibiotic treatment for
CDI has been completed. As a physician, being able to prevent patients with
CDI to go down the path of multiple recurrence is truly a game changer for the
treatment of this disease."

 

Dr. Mark Wilcox, Head of Research and Development in Microbiology at the Leeds
Teaching Hospitals, commented:

"Early model and clinical trial data show that NTCD-M3 can effectively block
the action of pathogenic C. difficile strains and so reduce the risk of
recurrent CDI.  The results of the forthcoming Phase 3 trial are eagerly
awaited to confirm the effectiveness of this non-antibiotic approach to
reducing the risk of recurrent C. difficile infection."

 

NTCD-M3 is a novel biotherapeutic for prevention of recurrence of CDI and it
is composed of a single bacterial strain, a naturally occurring non-toxigenic
C. difficile strain -M3. Rather than acting by restoring the microbiota after
the antibiotics used to treat the infection have disrupted the gut microbiota
it acts by colonising the gut with a harmless non-toxigenic strain of C.
difficile, which prevents subsequent colonisation by toxigenic strains and
allows the normal microbiota to recover on its own. NTCD-M3 colonisation is
both safe and effective and does not permanently alter the microbiota.

 

If NTCD-M3 is successful in its planned Phase 3 trials in around 800 patients,
it will be approved under a BLA (Biological Licence Application) by the FDA in
the US for the prevention of recurrence in CDI and under a MAA in Europe.

 

The NTCD-M3 development focuses on patients with a primary episode of CDI and
first recurrence. Thus, it is clearly differentiated from other products in
development as NTCD-M3 is positioned as an early intervention to reduce the
risk of recurrences.

 

According to the US Center for Disease Control and Prevention (CDC), C.
difficile causes almost half a million infections in the USA each year. This
number clearly indicates how significant the impact of C. difficile infections
is on healthcare costs and the potential for NTCD-M3 to prevent these costs
and to bring substantial value to healthcare systems and the patients in need.
It represents a significant commercial opportunity for Destiny Pharma.

 

For further information, please contact:

 

Destiny Pharma plc
Neil Clark, CEO

Shaun Claydon, CFO

+44 (0)1273 704 440
pressoffice@destinypharma.com
(https://www.destinypharma.com/2022/05/26/26-may-2022-destiny-pharma-plc-board-changes/blank)

 

Optimum Strategic Communications  (https://www.optimumcomms.com/)
Mary Clark / Manel Mateus / Eleanor Cooper

+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com
(https://www.destinypharma.com/2022/05/26/26-may-2022-destiny-pharma-plc-board-changes/blank)

 

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

Alice Lane / Nigel Birks / Harriet Ward, ECM

+44 (0) 207 220 0500

 

MC Services AG
Anne Hennecke / Andreas Burckhardt

+49-211-529252-12

 

Stern IR - USA

Lilian Stern / Janhavi Mohite

+1-212-362-1200

 

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 also 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(TM), a novel, biotherapeutic product for the
prevention of COVID-19 and other viral respiratory infections and has earlier
grant funded XF drug research projects.

 

For further information on the company, please visit www.destinypharma.com
(https://www.destinypharma.com)

 

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