Long-Awaited 'Cocoa' Based Drug for Treatment of Persistent Cough in Final Development

By Seek, PRNE
Sunday, December 19, 2010

First Effective Non-Opioid Treatment in Two Decades Could be Available Within Two Years

LONDON, December 20, 2010 - A breakthrough drug containing theobromine, an ingredient
naturally present in cocoa and chocolate, is entering the final stages of
human clinical trials for the treatment of persistent cough, researchers
announced today. The drug is being jointly developed by SEEK, a leading UK
privately-owned drug-discovery group, and could be on the market within two

A persistent problem

Persistent cough is a very common condition, afflicting over
800 million worldwide, with an estimated 12% of the general population (7.5
million in the UK), having the symptom on a daily or weekly basis.[1]
Persistent cough, defined as a cough that persists for more than two weeks,
has numerous causes but falls into two broad categories; that causing an
asthma-like syndrome of the airways and oesophageal reflux. Failure to treat
cough can lead to enormous consequences in terms of loss of employment,
healthcare utilisation and a psychosocial morbidity.

The issue with current opioid treatments

The majority of currently-available cough products soothe the
symptoms rather than deal with the root cause of the problem. Those that do
more than soothe are all codeine-based - an opioid - and have recently been
shown to have serious safety concerns due to differences in the way codeine
is metabolised into morphine. So much so that, in October 2010, the MHRA
(Medicines and Health products Regulatory Agency) advised that
codeine-containing over-the-counter liquid medicines should not be used for
cough-suppression in children and people younger than 18 years, as
"…overall, the risks of over-the-counter cough medicines for children
containing codeine outweigh the possible benefits".[2]

No new non-opioid based treatment has been developed in two
decades, and Professor Alyn Morice, a leading expert in the treatment of
cough, and Head of the Hull Cough Clinic, highlights the problem: "Thousands
of people across the UK suffer from persistent cough, and due to the
drawbacks of current opioid drugs such as codeine, we are in desperate need
of a non-opioid treatment with a drastically improved side effect profile for

Human trial research in Korea has shown that theobromine has
none of the side effects associated with standard drug treatments for
persistent cough.

The benefits of theobromine

Theobromine has been shown to inhibit the inappropriate firing
of the vagus nerve, which is a key feature of persistent cough. This
peripheral mechanism of action differentiates theobromine from codeine and
other centrally acting agents, and lessens its lower central nervous system
side effects.

Other beneficial effects of theobromine are a well-known; in
modern medicine, it has been used as a vasodilator (a blood vessel widener),
a diuretic (urination aid), and heart stimulant. It is found in significant
quantities in cocoa-based products, including chocolate, and is a metabolite
of caffeine.

Availability within two years

Following consultation with a European Medicines Agency (EMA),
the single Phase III trial of theobromine (BC1036) is expected to begin in
the UK in the first half of 2011. The drug has the potential to be on the
market in Europe within two years from trial commencement, subject to
receiving final marketing authorisation.

Manfred Scheske, CEO of Consumer Health at SEEK said:
"Persistent cough is a very common condition, often lasting for weeks after a
viral infection. It can be difficult to treat, especially since it is not
possible to give large doses of opiate-based medication to patients due to
side-effect issues. I am very excited to announce the progression for the
late-stage development of BC1036, which has the potential to dramatically
impact the treatment of persistent cough and could greatly benefit the
quality of life of persistent cough sufferers."

About SEEK

Founded in 2004, SEEK - previously known as PepTcell - is
privately-owned and funded, with headquarters in London, UK. Using a
pioneering scientific and commercially-driven approach, SEEK aims to create
breakthrough medicines which address major diseases in order to radically
improve human health. SEEK's strategy is to take promising molecules through
the challenging stages of discovery to late-stage human proof-of-principle
and then to seek partners to take the molecules through the final stages of
development and ultimately commercialisation. SEEK's current
product-development areas are vaccines, inflammation/autoimmune diseases,
transplantation tolerance induction, respiratory diseases, cancer and

For further information about SEEK please visit


1. Chronic Respiratory Disease 2008; 5: 43-47. AH Morice. Review Series:
Chronic cough: Epidemiology.

2. MHRA Safety warning, October 2010:

(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)

SEEK: Gregory Stoloff, Chief Executive Officer, Tel: +44(0)20-7153-6570 . M: Communications: Nick Francis, Tel: +44(0)20-7920-2320; Amber Bielecka, Tel: +44(0)20-7920-2352.

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