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Regeneron says anti-NGF fasinumab works in pain

Clinical trial shows promise for opioid alternative

Regeneron's nerve growth factor (NGF) inhibitor fasinumab has shown promise in a phase II/III trial, rekindling hopes of an alternative to opioids for chronic pain.

The trial - in patients with moderate-to-severe chronic pain caused by osteoarthritis - showed that fasinumab dosed by injection once a month was able to provide a significant improvement in pain relief compared to placebo at all doses tested.

The 421 patients enrolled into the trial were all dealing with inadequate pain relief or intolerance to other analgesic drugs, including opioids, which carry a risk of dependency as well as unpleasant side effects such as severe constipation.

Diversion and abuse of opioid drugs has reached epidemic proportions in the US and other countries around the world, and there is a desperate need for an alternative painkiller class. NGF has been targeted for years because it operates at the heart of multiple pain-signalling pathways.

"There is a real need for new, non-opioid pain therapies that can provide relief to patients without the toxicity and potential for abuse of currently available opioid treatments," commented Regeneron's chief scientific officer George Yancopoulos.

"We had previously evaluated an intravenous formulation of fasinumab in osteoarthritis patients, and this is our first trial of a convenient subcutaneous monthly regimen," he added.

Regeneron's trial is particularly encouraging because efforts to develop anti-NGF drugs for chronic pain have to date resulted in a string of failures, with candidates such as AstraZeneca's Medi-578 and AbbVie's ABT-110 among those dropped from development.

In 2011 the FDA placed the entire class on clinical hold on fears they may cause joint damage and peripheral nervous system side effects. That hold was subsequently relaxed to a partial hold, allowing some drugmakers to resume testing and leading to optimism that anti-NGF programmes may get back on track.

A few weeks ago Johnson & Johnson (J&J) returned rights to its fulranumab candidate to originator company Amgen, despite the drug already being in multiple phase III trials. The decision was attributed to shifting commercial priorities rather than a safety or efficacy issue, but added to the anxiety among anti-NGF developers.

Regeneron designed its phase II/III trial specifically to address the concerns about destructive joint damage, and carried out imaging to gauge whether there was any imbalance between the drug and placebo on fractures, bone destruction and disease progression.

There were few detectable differences between the groups, although there more cases of subchondral insufficiency fractures (six for fasinumab and one for placebo) as well as a small increase in bone-specific alkaline phosphatase - a marker of the activity of bone-secreting cells called osteoblasts - in the fasinumab-treated group.

Eli Lilly and Pfizer restarted trials of their tanezumab anti-NGF candidate last year in the wake of the relaxation of the FDA's clinical hold, focusing on osteoarthritis, chronic lower back pain, and cancer pain indications.

Given the sheer scale of opioid abuse and the need for new options, analysts have previously predicted that safe and effective NGF inhibitors could become a multibillion-dollar market opportunity.

Article by
Phil Taylor

5th May 2016

From: Research



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