Convergence Pharmaceuticals' Novel Nav1.7 Selective Sodium Channel Blocker CNV1014802 Demonstrates Proof of Concept in Second Neuropathic Pain Study in Lumbosacral Radiculopathy

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Sep 23, 2014, 02:58 ET

CAMBRIDGE, September 23, 2014 /PRNewswire/ --

Highlights of the data:

CNV1014802 showed a statistically significant reduction in pain
Well tolerated and effective therapeutic dose without any requirement for dose titration
Performance potentially broadens the use in several other neuropathic pain states

Convergence Pharmaceuticals Holdings Limited ("Convergence"), the company focused on the development of novel and high value analgesic medicines for the treatment of chronic pain, today announces positive data from the Phase II proof of concept study with CNV1014802 for treating pain associated with lumbosacral radiculopathy (LSR), more commonly known as sciatica.

CNV1014802 is a novel small molecule state-dependent sodium channel blocker that exhibits potency and selectivity against the Nav1.7 sodium channel. The Company recently reported excellent efficacy and safety in a ground-breaking Phase II trigeminal neuralgia study, a severe form of facial pain.

This is the second well powered, randomized and placebo controlled clinical trial to demonstrate clinical proof of concept of the selective state dependent Nav1.7 inhibitor, CNV1014802 in a chronic pain indication.

The Phase II trial was a randomised, double-blind, placebo-controlled cross-over study designed to evaluate the efficacy and safety of orally administered CNV1014802 at a dose of 350mg twice per day, in 81 patients with pain associated with LSR. There was a statistically significant difference in the primary endpoint between CNV101802 and placebo (Pain Intensity-Numerical Rating Scale (PI-NRS) mean change at week 3, -0.43; p=0.0265). Additional exploratory analyses showed that for the subset treated by '802 alone, comprising 60% of patients randomised, there was an enhanced statistically significant reduction in pain (PI-NRS mean change at week 3, -0.72; p=0.0039).

There were no serious adverse events related to the drug in this trial and as seen in all previous clinical studies, CNV1014802 was very well tolerated. Key to further clinical development and differentiation, CNV1014802 was delivered at an effective therapeutic dose without any requirement for dose titration.

Clive Dix, Chief Executive Officer of Convergence, commented: "We are delighted to have achieved clinical proof of concept with CNV1014802. This is the second positive study with this molecule and the data confirms our belief that this asset has potential to be a blockbuster treatment for neuropathic pain states. The Company will initially target the commercialisation of CNV1014802 in trigeminal neuralgia and other orphan drug conditions, however, these data confirm our belief that this molecule will have broad utility in neuropathic pain, including Sciatica."

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 followed by a further £6 million in a recent (July 2014) extension from current investors. For more information please go to the Company's website at http://www.convergencepharma.com.

About lumbosacral radiculopathy

Lumbosacral radiculopathy refers to a set of conditions in which one or more nerves is affected and does not work properly. The emphasis is on the nerve root. This can result in pain, weakness, numbness, or difficulty controlling specific muscles. The most common cause is structural - disc herniation or degenerative spinal stenosis - leading to root compression.

In a lumbosacral radiculopathy, the problem occurs at or near the root of the nerve, along the spine. However, the pain or other symptoms often radiate to the part of the body served by that nerve.

Sciatica is a relatively common form of low back and leg pain. Sciatica is a set of symptoms rather than a diagnosis for what is irritating the root of the nerve to cause the pain. Treatment for sciatica or sciatic symptoms often differs, depending on underlying causes and pain levels. Causes include compression of the sciatic nerve roots by a herniated (torn) or protruding disc in the lower back.

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. The global pain management market is set to reach US$60 Billion by 2015^[¹^].

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.

References:

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

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

For more information about Convergence Pharmaceuticals, please contact:

Convergence Pharmaceuticals
Dr Clive Dix, Chief Executive Officer
Brenda Reynolds, Chief Operating Officer
Dr Simon Tate, Chief Scientific Officer

T: +44(0)1223-755-501
E: [email protected]

Consilium Strategic Communications
Mary-Jane Elliott/ Amber Bielecka/ Matthew Neal/ Lindsey Neville

T: +44(0)20-3709-5700
E: [email protected]