Convergence Pharmaceuticals Announces Start of Phase II Study for its Selective Nav 1.7 blocker CNV1014802

By Convergence Pharmaceuticals, PRNE
Monday, July 18, 2011

CAMBRIDGE, England, July 19, 2011 -

Convergence Pharmaceuticals Limited (”Convergence”), the company
focused on the development of novel and high value analgesic
medicines, today announces that the Phase II proof of concept study
with CNV1014802 for treating pain associated with lumbosacral
radiculopathy (LSR) has started.

LSR is a common neuropathic pain condition caused by compression
of the nerve roots in the lumbar region of the spine. Common
features include pain radiating from the lower back down the legs,
together with sensory and motor impairment in the lower limbs. LSR
is a very high unmet medical need, affecting 3-5% of the global
population and there are no drug treatments currently approved for
treating this type of neuropathic

The Phase II trial is a randomised, double-blind,
placebo-controlled study designed to evaluate the efficacy and
safety of orally administered CNV1014802 in patients with pain
associated with LSR. It is an innovative study, incorporating a
number of design features which will enhance confidence in the
outcome of the study. The trial will run in four European countries
and results are expected in the second half of 2012.

Clive Dix, Chief Executive Officer of Convergence
Pharmaceuticals, added:
“We are delighted to announce the start
of this trial; the second clinical stage trial initiated since our
conception as a Company in October 2011 and a testament to our
innovative team. It is clear that safe, effective pain treatment is
urgently required and we are focussed on driving forward the
development of our pipeline to meet this need.”

Commenting on the announcement, Simon Tate, Chief Scientific
Officer of Convergence Pharmaceuticals, said:
“We are very
excited to be initiating this Phase II study for CNV1014802.
 CNV1014802’s differentiated and superior profile could have a
significant impact on the treatment of patients with pain
associated with lumbosacral radiculopathy (LSR), who currently have
no approved treatment available to them.  CNV1014802 offers
the potential of a safe, effective treatment for this common
neuropathic pain.”

CNV1014802is a novel small molecule, state-dependent
sodium channel blocker that exhibits potency against the Nav1.7
sodium channel. It was recently validated as a key pain target by
human genetic linkage.[2] Exciting new data
generated by Convergence scientists showed that while displaying a
highly state-dependent block of those sodium channels conveying
painful sensations, CNV1014802 has a superior and differentiated
profile of activity at Nav1.7. This profile translates into
significant block of Nav1.7 channels in experimental paradigms
which mimic the higher frequency and spontaneous neuronal firing,
observed in entrapment neuropathies such as LSR.

CNV1014802 has completed extensive Phase I studies with single
and repeated doses in over 150 healthy volunteers, demonstrating an
excellent pharmacokinetic and safety profile. CNV1014802 also
demonstrated an ideal pharmacokinetic profile together with
excellent toleration at doses within the expected therapeutic

The need for new drug treatments for
chronic pain

The Pain therapeutic area encompasses any disease where pain is
a major symptom. The unmet medical need for patients in pain is
enormous, with the greatest need being for a more effective therapy
that is well tolerated and safe over a long period of time. Within
the pain marketplace, current pain treatments are unsatisfactory;
overall efficacy is poor (typically 1-2 point reductions on a 10
point scale) and satisfactory to less than 50% of patients. Whilst
treatments, such as opioids and non-steroidal anti-inflammatory
drugs, are available on the market, many patients obtain little or
no relief from these existing analgesics. Often such drugs are
associated with adverse events, side effects and addiction
concerns, leading to the observation in a recent report by the US
Institute of Medicine that a “cultural transformation” is necessary
to better prevent, assess, treat, and understand pain of all

This highlights the importance of Convergence Pharmaceuticals’
goals to develop novel, efficacious analgesics with improved
pharmacology and safety profiles.

About chronic pain

Currently, more than 1.5 billion people worldwide suffer from
chronic pain of varying degrees, with an estimated 116 million
American adults affected by chronic pain - more than heart disease,
cancer and diabetes combined.[4] Among all
types of chronic pain, neuropathic pain stands out with
approximately 3-4.5% of the global population affected, with
incidence rate increasing in line with increased age of the
population. With the unmet clinical need so high, the demand for
better pain management therapies, addressing acute and chronic
pain, is on the rise.

According to recent research the global pain management market
is to reach US$60 Billion by 2015.[5]


  1. Tarulli and Raynor., Nerol Clin. 2007, May; 25(2):
  2. Ramin Raouf, Kathryn Quick and John N. Wood, Pain as
    Journal of Clinical Investigation, 2010 November
    , 120(II): pp.3745-3752
  3. Report by the Institute of Medicine, Relieving Pain in
    America: A Blueprint for Transforming Prevention, Care, Education,
    and Research
    , June 2011
  4. Report by the Institute of Medicine, Relieving Pain in
    America: A Blueprint for Transforming Prevention, Care, Education,
    and Research
    , June 2011
  5. Global Industry Analysts Inc. 2010, Pain Management: A
    Global Strategic Business Report


About Convergence Pharmaceuticals

Convergence Pharmaceuticals is an independent biotechnology
company focused on the development of novel analgesics with
potentially commercially attractive efficacy, responder-rate and
side effect profiles. The Company, led by CEO Clive Dix, was formed
in October 2010 following the acquisition of certain neuroscience
clinical assets from GlaxoSmithKline (”GSK”). Convergence
Pharmaceuticals has a pipeline of differentiated clinical-stage
compounds targeting the points of convergence in chronic pain
signalling through modulation of specific ion-channels. Convergence
Pharmaceuticals is well funded and raised $35.4 million in Series A
financing from a syndicate of leading European and US financial
institutions. For more information please go to the Company’s
website at href="">

For more information about Convergence
Pharmaceuticals, please contact:

    Convergence Pharmaceuticals

    Dr Clive Dix, Chief Executive Officer   T: +44(0)1223-755-501
    Dr Simon Tate, Chief Scientific Officer E:

    M:Communications                        T: +44(0)20-7920-2330
    Mary Clark / Amber Bielecka             E:


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