# Poolbeg Pharma enters Exclusive Option Agreement for novel Behçet’s Disease treatment

- Link: https://www.directorstalkinterviews.com/poolbeg-pharma-enters-exclusive-option-agreement-for-novel-behcets-disease-treatment/4121154099
- Published: 2024-04-30T07:33:00+01:00
- Author: Amilia Stone

**[Poolbeg Pharma plc](https://www.directorstalkinterviews.com/company/poolbeg-pharma-plc/polb.l)**(
[LON:POLB](https://www.directorstalkinterviews.com/company/poolbeg-pharma-plc/polb.l),
OTCQB: POLBF), 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]](https://www.londonstockexchange.com/#_ftn1))
Patients also suffer from reduced psychosocial quality of life^([[2]](https://www.londonstockexchange.com/#_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.”_

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