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Last updated on April 20, 2014 at 7:57 EDT

Convergence Pharmaceuticals Announces Start of Phase II Study for Cav2.2 Selective Blocker, CNV2197944 in Pain Associated with Diabetic Peripheral Neuropathy (DPN)

July 8, 2013

CAMBRIDGE, England, July 8, 2013 /PRNewswire/ –

Convergence Pharmaceuticals Limited (“Convergence”), the company focused on the
development of novel and high value analgesic medicines for the treatment of chronic pain,
today announces that it has started a Phase II proof of concept study with CNV2197944 in
pain associated with diabetic peripheral neuropathy (DPN). Results from the study are
expected in the second half of 2014.

The trial is a randomised double-blind, placebo controlled, Phase II, two period, two
treatment crossover study to compare the efficacy and safety of a dose regime of
CNV2197944 75mg tid versus placebo in patients with DPN. The primary endpoint of the trial
is the effect of repeat oral dosing of CNV2197944 on the pain experienced in DPN, as
measured by the Pain Intensity Numeric Rating Scale (PI-NRS), after three weeks, compared
to baseline.

Diabetic peripheral neuropathy (DPN) is defined as peripheral somatic or autonomic
nerve damage attributable to diabetes mellitus. DPN is characterised by numbness and
paraesthesia, typically of a burning quality with nocturnal worsening, most frequently in
the feet and ankles and to a lesser extent in the upper extremities. Symptoms may also
include spontaneous deep aching pain and/or shooting pain, thermal hyperalgesia, and
tactile allodynia. It is estimated that up to a quarter of all diabetic patients will
suffer from peripheral neuropathic pain and with only a third of diagnosed patients
achieving greater than 50% pain relief, DPN presents a huge unmet clinical need.

CNV2197944 is a novel, small molecule, state-dependent calcium channel blocker,
designed to selectively inhibit highly active Cav2.2 channels. Based on positive
pre-clinical and clinical data already reported, it is believed that CNV2197944 will be an
effective treatment for neuropathic pain with analgesic potential for a broad range of
chronic pain conditions. Extensive safety and toxicology studies to support the clinical
development of CNV2197944 have also been completed, which suggest an excellent margin of
safety and tolerability. CNV2197944 is the only truly selective Cav2.2 blocker in clinical
development and has the potential to be a first in class treatment for chronic pain.

Convergence is conducting the development of CNV2197944 on behalf of Calchan Ltd.

Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals, commented: “We have
begun running a second proof of concept trial with CNV2197944 in neuropathic pain and are
already excited about potential results. Based on the known pre-clinical and clinical
profile of CNV2197944, and the data we have seen so far, we believe it will be a safer,
more effective treatment for chronic pain, with a potentially better tolerability profile
and wider therapeutic index than currently available treatments.”

About the pain therapeutic area

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 and often such drugs are associated with adverse events, side effects and
addiction concerns. This highlights the importance of Convergence Pharmaceuticals’ goals
to be a world leader in the development of 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. 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.[1]

About Calchan

As part of a restructuring of Convergence in 2011, CNV2197944 was subsequently
transferred into Calchan Ltd, a sister company of Convergence Pharmaceuticals in which the
proprietary rights to CNV2197944 are held. Calchan Ltd is developing its own portfolio of
Calcium ion channel modulators and has contracted Convergence to undertake certain
development activities with CNV2197944 on its behalf.

References:

        1) Global Industry Analysts Inc. 2010, "Pain Management: A Global Strategic
          Business Report".

http://www.strategyr.com/Pain_Management_Market_Report.asp

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”). The Company 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 US$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 http://www.convergencepharma.com

        For more information about Convergence Pharmaceuticals, please contact:

        Convergence Pharmaceuticals
        Dr Clive Dix, Chief Executive Officer
        Dr Simon Tate, Chief Scientific Officer
        T: +44(0)1223-755-501
        E: info@convergencepharma.com

        M:Communications
        Mary-Jane Elliott/ Amber Bielecka/ Matthew Neal
        T: +44(0)20-7920-2330
        E: convergence@mcomgroup.com

SOURCE Convergence Pharmaceuticals


Source: PR Newswire