Convergence Pharmaceuticals Initiates Phase I Multiple Ascending Dose Study for CNV2197944
CAMBRIDGE, England, November 21, 2011 /PRNewswire/ –
Phase I Single Dose Study Data Demonstrate Ideal Pharmacokinetic Profile
and Excellent Safety and Tolerability
Convergence Pharmaceuticals Limited (“Convergence”), the company focused
on the development of novel and high value analgesic medicines, today
announces that the multiple ascending dose Phase I study of the novel, first
in class calcium channel blocker CNV2197944, for the treatment of chronic
pain has been initiated.
The trial is a randomised, placebo controlled Phase I study to
investigate the pharmacokinetics, safety and tolerability of orally
administered multiple dose regimens of CNV2197944 in both young and elderly
volunteers. CNV2197944 is proposed for development initially as a treatment
for neuropathic pain and pain associated with osteoarthritis. The study is
expected to conclude in 2Q 2012.
The first human single ascending dose Phase I study with orally
administered CNV2197944 was recently completed. CNV2197944 was shown to be
well absorbed, with an ideal pharmacokinetic profile for the target
indication of chronic pain. The compound was well tolerated, with an
excellent safety profile.
Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals,
commented: “We are really excited to be advancing on schedule to a multiple
ascending dose study with this novel, first-in-class treatment for chronic
pain. The data we have seen so far gives us great confidence that CNV2197944
will be a safe and effective long term treatment for chronic pain.”
CNV2197944 – a first in class molecule with potential to be a first in
CNV2197944 is a novel, small molecule, state-dependent calcium channel
blocker, designed to selectively inhibit highly active Cav2.2 channels.
Preclinical studies demonstrated that CNV2197944 could have 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
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 types.
This highlights the importance of Convergence Pharmaceuticals’ goals to
develop novel, efficacious analgesics with improved pharmacology and safety
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. 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) Report by the Institute of Medicine, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, June 2011 2) Report by the Institute of Medicine, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, June 2011 3) 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. There are two
molecules in its development portfolio for the treatment of chronic pain,
CNV1014802 which is in Phase II development for the treatment of lumbosacral
radiculopathy (LSR) and CNV2197944 which is in Phase I development. Clinical
Development activities for CNV2197944 are being conducted by Convergence
Pharmaceuticals Ltd on behalf of Calchan Ltd.
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
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: email@example.com M:Communications Mary Clark / Amber Bielecka / Hollie Vile T: +44(0)20-7920-2330 E: firstname.lastname@example.org
SOURCE Convergence Pharmaceuticals Ltd