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Merck seeks partner for disease-modifying osteoarthritis drug

Sprifermin data from the FORWARD phase 2 study published

Merck KGaA

Merck KGaA says it has data showing its sprifermin drug is the first to affect the underlying disease process in osteoarthritis – and is looking for a partner to take the programme forward.

The German drugmaker said today that data from the FORWARD phase 2 study has been published in the Journal of the American Medical Association (JAMA) and shows that sprifermin significantly improved cartilage thickness in knee osteoarthritis after two years.

Osteoarthritis lies outside Merck’s areas of interest, however, and the company says it is looking for “external partnership opportunities” for sprifermin and other osteoarthritis projects, while focusing its internal efforts on neurological conditions with inflammatory mechanisms such multiple sclerosis and lupus.

Sprifermin is a recombinant human fibroblast growth factor-18 that is delivered by injection into the joint every six or 12 months. The JAMA study shows that at a dose of 100 µg the drug seems to have an effect on cartilage while a lower dose (30 µg) and placebo made no difference.

That indicates a dose-response effect, says Merck, although for now the clinical significance of the increase in thickness isn’t clear, as all three groups – including placebo – reported a 50% reduction in symptom scores. New data from a three-year follow-up assessment suggests that the increase in cartilage is maintained.

There are no approved therapies for osteoarthritis that have been shown to affect the underlying course of the disease. The estimated 237 million people with the disease around the world have to rely on cheap generic painkillers and non-steroidal anti-inflammatory drugs (NSAIDs) that have been around for decades but only treat symptoms.

A few other disease-modifying candidates are coming through the pipeline, but few have progressed beyond early- to mid-stage clinical testing.

Among those in the later stages of development include Samumed’s Wnt inhibitor lorecivivint (SM04690), which started phase 3 in May, and Galapagos/Servier’s ADAMTS-5 inhibitor GLPG1972 which has completed enrolment in a phase 2 study due to read out next year.

One new treatment – Kolon/TussueGene’s cell-based therapy Invossa – caused a scandal after it was approved in South Korea and then withdrawn just a few months later over mislabelling and the false reporting of ingredients.

Article by
Phil Taylor

11th October 2019

From: Research

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