New drug trial could help relieve the pain of diabetes

UK patients with diabetic neuropathy are being recruited for a phase II clinical trial which will evaluate the safety, tolerability and efficacy of a novel class of analgesic

The trial will be the first of its kind to investigate the potential of an innovative drug which can prolong the body's own natural painkillers. PL37, a Dual Enkephalinase Inhibitor (DENKI), is an exciting and long-awaited, novel class of analgesic for chronic pain conditions.

The clinical trial aims to find volunteers from across the UK (with peripheral neuropathic pain of diabetic origin) to take part in the 12-centre study and discover if PL37 can reduce the pain intensity of the condition. GPs, practice nurses and diabetes specialists understand that for many patients diabetic neuropathy is managed unsatisfactorily by current drugs.

"Some patients experience the painful tingling of neuropathy even with well-managed diabetes and despite their pain medication. New research into alternatives will be welcomed by doctors and patients alike," comments Professor Solomon Tesfaye MD FRCP, vice chair of the Diabetes UK's Science and Research Advisory Group.

PL37 is an orally administered DENKI with a unique mechanism in the body. The body's natural painkillers - enkephalins - degrade quickly, but DENKIs are able to inhibit the enzymatic degradation of these peptides. In essence DENKIs prolong the life of the body's own natural pain relieving processes. DENKIs elicit lasting analgesic effects - as potent as those of morphine - but without the side effects.

DENKI PL37 has completed extensive phase I patient trials and was very well tolerated, even at high oral doses. Although some patients reported mild side-effects, such as diarrhoea and headaches. DENKIs have been shown to enhance the benefit of other pain medications. It appears that patients suffering from neuropathic pain and who are only partially relieved by pregabalin or gabapentin may significantly benefit from the addition of oral PL37 to their background medication. The research study will find out if PL37, when given with pregabalin or gabapentin, is effective at reducing neuropathic pain for people with diabetes.

Pharmaleads, the company leading the clinical trial, is looking to recruit patients from across the UK to take part in a four week study. "With the help of volunteers we may uncover a more effective treatment to manage the pain that some people with diabetes face and help change the impact of the disease for future generations," adds Professor Tesfaye.

The study is open to patients with adequately controlled diabetes (HbA1c ≤10% or 86 mmol/mol), aged ≥18 years and ≤75 years, who have been diagnosed - confirmed by pain specialist or endocrinologist - with peripheral neuropathic pain of diabetic origin, lasting for at least three months. Participants must also be receiving stable treatment with pregabalin or gabapentin for at least one month prior to screening visit.

There are 12 hospitals across the UK taking part in the research at centres in London, Edinburgh, Manchester, Liverpool, Birmingham, Sheffield, Bath, Bournemouth, Oldham, Chorley, Poole and St Helens.

If you are a Healthcare Professional and would like to find out more information on the 'DENKI PL37 for diabetic neuropathy' trial please email info@pharmaleads.com to request the clinical or patient literature. Alternatively visit www.pharmaleads.com.