REG - Poolbeg Pharma PLC - Option Agreement to Acquire Orphan Drug Candidate

Poolbeg PharmaAnnouncement

30/04/2024 07:15

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RNS Number : 4926M  Poolbeg Pharma PLC  30 April 2024

Poolbeg Pharma plc

Exclusive Option Agreement to Acquire Orphan Drug Candidate for Behçet's
Disease

Novel therapeutic with Fast Track and Orphan Designation

30 April 2024 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the
'Company'), a biopharmaceutical company focussed on the development and
commercialisation of innovative medicines targeting diseases with a high unmet
medical need, announces that it has entered into an exclusive 12-month option
agreement with Silk Road Therapeutics Inc,  for a nominal fee, to acquire a
novel topical muco-adherent formulation of Pentoxifylline (tPTX) for the
treatment of oral ulcers in patient's suffering from Behçet's Disease.

Key Highlights

·    12-month option agreement with Silk Road Therapeutics to acquire
novel topical muco-adherent formulation of Pentoxifylline (tPTX), a treatment
for oral ulcers in patient's suffering from Behçet's Disease which currently
has no cure

·    Phase 2 trial successfully completed, demonstrating superiority over
standard of care

·    Secured Orphan Drug Designation and Fast Track Designation from the
FDA

·    Positioned for a potential 505(b)(2) approval pathway in the U.S.

·    Poolbeg will continue due diligence throughout the term of the
exclusive option agreement which will include engagement with Silk Road
Therapeutics to ascertain the clinical approval pathway

There is a clear unmet medical need for an effective treatment for this rare
disease, which has no cure. Behçet's Disease causes inflammation of blood
vessels and tissues, resulting in debilitating symptoms, the most common being
oral ulcers which impact essential functions like eating, drinking and
speaking. 1  (#_ftn1) Patients also suffer from reduced psychosocial quality
of life 2  (#_ftn2) . Current standard of care is inadequate with safety
concerns and there is a clear need for alternative treatment options.

The topical formulation of PTX, a small molecule with broad anti-inflammatory
activity, has successfully demonstrated accelerated oral ulcer healing and
decreased pain compared to standard of care in patients with Behçet's Disease
in a Phase 2 clinical trial.

The drug is positioned for a potential 505(b)(2) approval pathway in the U.S.
which can result in a much less expensive and much faster route to approval
and commercialisation. tPTX has successfully secured FDA Fast Track
Designation, designed to expedite development and review of certain medicines.
It has also received Orphan Drug Designation from the FDA, providing seven
years of market exclusivity upon marketing authorisation.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: "The
foundation of any pharma company is a strong pipeline of assets, and we
believe that topical PTX could fit well into our pipeline alongside our other
assets as we increase our focus on rare and orphan diseases.

"We are delighted to enter this exclusive option agreement with Silk Road
Therapeutics and Dr Timothy Coté, whose extensive experience, including as
Director of the FDA Office of Orphan Products Development, adds invaluable
insights into the regulatory pathway and ultimate approval and
commercialisation of the drug.

"tPTX has the potential to transform the lives of patients suffering from
Behçet's Disease, who currently lack effective and safe long term treatment
options. Under this exclusive option agreement, we will advance our due
diligence process and engage with Silk Road Therapeutics to further understand
the clinical pathway to approval, and we look forward to updating the market
in due course."

Timothy R. Coté, M.D., M.P.H., Chief Executive Officer of Silk Road
Therapeutics, said: "Poolbeg Pharma shares our commitment to advancing
healthcare innovation to support rare disease patients. With Fast Track
Designation and Orphan Drug Designation secured, topical PTX has the potential
to swiftly reach patients and offer a potentially transformative solution for
those suffering from Behçet's Disease."

Investor presentation

Poolbeg Pharma CEO, Jeremy Skillington, PhD, and CBO David Allmond, along
with Dr Timothy Coté, CEO of Silk Road Therapeutics, will provide a live
presentation via the Investor Meet Company platform on Tuesday 30 April
2024 at 6pm BST.

 

The presentation is open to analysts and investors, those who already follow
Poolbeg on the Investor Meet Company platform will automatically be
invited. Investors can sign up to Investor Meet for free and add Poolbeg
Pharma plc to their company dashboard
via: https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor)

 

Enquiries

 Poolbeg Pharma Plc                                                      +44 (0) 207 183 1499

 Jeremy Skillington, CEO

 Ian O'Connell, CFO

 Cavendish Capital Markets Ltd (Nominated Adviser & Joint Broker)        +44 (0) 207 220 0500

 Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)

 Singer Capital Markets (Joint Broker)                                    +44 (0) 207 496 3000

 Phil Davies, Sam Butcher

 J&E Davy (Joint Broker)                                                 +353 (0) 1 679 6363

 Anthony Farrell, Niall Gilchrist

 Optimum Strategic Communications                                        +44 (0) 208 078 4357

 Nick Bastin, Vici Rabbetts, Elena Bates                                 poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

About Behçet's Disease

Behçet's Disease is a rare condition that results in inflammation of the
blood vessels and tissues. Inflammation across multiple parts of the body
leads to diverse symptoms, the most prevalent being recurrent oral ulcers, in
addition to genital ulcers and inflammation of the eye and skin lesions. It is
not yet known what triggers the disease or causes it to persist. However, it
is clear there is a significant immune component with some suggestions that
exaggerated responses to pathogens and increased cytokine and chemokine
production may play key roles in the disease. 3  (#_ftn3)

About Poolbeg Pharma

Poolbeg Pharma plc is committed to the development and commercialisation of
innovative medicines targeting diseases with a high unmet medical need, with a
growing emphasis on rare and orphan diseases. Its model focusses upon
developing its exciting clinical assets and commercialising approved and
marketed drugs to support the growth of the Company and the development of its
robust pipeline of innovative products, thereby driving significant value
creation.

Poolbeg is led by an experienced leadership team with a history of delivering
significant shareholder value. The team has been strengthened by the
appointment of three former members of the Amryt Pharma plc leadership team,
with the intention of repeating Amryt's success and generating near term
revenues.

Poolbeg's clinical programmes target large addressable markets including
cancer immunotherapy-induced CRS, infectious disease, and metabolic conditions
such as obesity with the development of an oral GLP-1R agonist. It uses a
cost-effective development philosophy to generate high quality human data to
support partnering and further development. Its AI-led infectious disease
programmes analyse unique data from human challenge trials to identify
clinically relevant drug targets and treatments, leading to faster development
and greater commercial appeal.

For more information, please go to www.poolbegpharma.com
(http://www.poolbegpharma.com/)  or follow us on Twitter
(https://twitter.com/PoolbegPharma)  and LinkedIn
(https://www.linkedin.com/company/poolbeg-pharma/)  @PoolbegPharma.

Forward-Looking Statements

This announcement may contain forward-looking statements and the words
"expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast",
"project" and similar expressions (or their negative) identify certain of
these forward-looking statements. The forward-looking statements in this
announcement are based on numerous assumptions and Poolbeg's present and
future business strategies and the environment in which Poolbeg expects to
operate in the future. Forward-looking statements involve inherent known and
unknown risks, uncertainties and contingencies because they relate to events
and depend on circumstances that may or may not occur in the future and may
cause the actual results, performance or achievements to be materially
different from those expressed or implied by such forward-looking statements.
These statements are not guarantees of future performance or the ability to
identify and consummate investments. Many of these risks and uncertainties
relate to factors that are beyond Poolbeg's ability to control or estimate
precisely, such as future market conditions, currency fluctuations, the
behaviour of other market participants, the outcome of clinical trials, the
actions of regulators and other factors such as Poolbeg's ability to obtain
financing, changes in the political, social and regulatory framework in which
Poolbeg operates or in economic, technological or consumer trends or
conditions. Past performance should not be taken as an indication or guarantee
of future results, and no representation or warranty, express or implied, is
made regarding future performance. No person is under any obligation to update
or keep current the information contained in this announcement or to provide
the recipient of it with access to any additional relevant information.

 1  (#_ftnref1) Hatemi G, Yurttas B, Kutlubay Z, Cote T, Derkunt S, Yazici Y,
Yazici H. Pentoxifylline Gel for Oral Ulcers in Patients with Behçet's
Syndrome  abstract . Arthritis Rheumatol. 2019; 71 (suppl 10).
https://acrabstracts.org/abstract/pentoxifylline-gel-for-oral-ulcers-in-patients-with-behcets-syndrome/.
Accessed April 17, 2024.

 2  (#_ftnref2) Ali S, Nagieb CS, Fayed HL. Effect of Behcet's
disease-associated oral ulcers on oral health related quality of life. Spec
Care Dentist. 2023 Jul-Aug;43(4):435-442. doi: 10.1111/scd.12782. Epub 2022
Sep 20. PMID: 36127751.

 3  (#_ftnref3) behcetsuk.org

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