Stragen Group has announced the enrolment of the first patient in a Phase I clinical trial for its novel non-opioid analgesic, STR-324.

STR-324 is an endogenous dual enkephalinase inhibitor (DENKI) that has demonstrated efficacy in post-operative and neuropathic animal pain models.

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The upcoming trial marks the first time the treatment will be tested in human models. The study’s primary endpoints are to examine the safety and efficacy of short and long infusions of STR-324, with secondary endpoints of determining the efficacy and pharmacokinetic after short and long infusions of STR-324 in healthy volunteers.

The study will be conducted by the Centre for Human Drug Research in Leiden, Holland, led by principal investigator Geert Jan Groeneveld. It is expected to enroll up to 78 patients.

“We are excited about commencing the clinical evaluation of STR-324 to further characterise the therapeutic potential of this drug candidate, which has shown an encouraging pre-clinical profile,” Stragen Group CEO M. Jean-Luc Tetard said.

“We are convinced this clinical study is an important step towards confirming STR-324’s potential as an innovative therapeutic option for millions of patients suffering from pain throughout the world”.

STR-324 was first discovered 10 years ago by the Pasteur Institute’s Catherine Rougeot.

On the upcoming trial, Rougeot said: “I am extremely happy to see how far we’ve come from making a scientific discovery to developing a drug which could have the power to provide patients with an alternative pain management.”

Enkephalins are natural analgesic peptides involved in endogenous opioidergic pain pathways. STR-324 inhibits various peptidases that break down enkephalins into inactive metabolites. The enkephalins’ action, which is the body’s natural response to pain, is thus amplified and analgesia is induced.

STR-324 could mark a turning point in pain medication, as it has thus far proven to be non-addictive. Trials of the drug on animal models demonstrated no ill-effects on respiratory, gastro-intestinal or central nervous systems.

In comparison opioids are extremely addictive and have high levels of gastrointestinal and respiratory toxicity, though their potency makes them some of the most commonly prescribed painkillers.

Opioid addiction remains a serious problem in many parts of the world, in particular the US where opioids are the cause of more deaths than any other drug; in 2017 the country reported almost 100 opioid-related deaths per day. The UK has the highest proportion of opioid addicts in Europe, with 3,744 opioid-related deaths in 2017.

Many believe that opioids are overprescribed, and that non-opioid alternatives can provide equally effective pain management. Such an idea has been the subject of numerous studies.

One such study was conducted by the Albany Medical Centre in November 2017, titled ‘Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department’. The study examined the efficacy of opioid-based medications on 411 patients with arm or leg injuries, in comparison with treatments based on a combination of ibuprofen and acetaminophen.

The researchers reported little distinction between the pain ratings of the patients in each arm, validating the idea that the choice of analgesic to treat acute pain in the emergency department often lacks a clear evidence base.