Novartis terminates phase 2 osteoarthritis trial testing ADAMTS-5 inhibitor

Novartis has terminated a phase 2 trial evaluating an investigational ADAMTS-5 inhibitor for patients with osteoarthritis knee pain.

The Big Pharma company discontinued the study testing intra-articular injection QUC398 after an interim analysis found an “insufficient effect on pain relief,” a Novartis spokesperson told Fierce Biotech.

The candidate demonstrated a “good safety profile,” the spokesperson added.

As a result of the trial termination, Novartis is discontinuing further development of QUC398 in knee osteoarthritis, the spokesperson said.

The randomized, placebo-controlled trial enrolled 101 patients, according to ClinicalTrials.gov. All participants will receive follow-up as per study protocol, the spokesperson told Fierce.

The spokesperson said they did not have information about whether Novartis would assess QUC398 in any other indication. The asset is not included in the pharma’s online pipeline.

In 2020, Novartis picked up an anti-ADAMTS5 nanobody from Merck KGaA for 50 million euros upfront. At the time, the asset known as M6495 was ready for phase 2 testing in osteoarthritis. It's unclear whether M6495 is QUC398.

ADAMTS-5 is an enzyme expressed in human cartilage. Previously, Galapagos and Servier teamed up to take their ADAMTS-5 inhibitor GLPG1972 (also known as S201086) through development for knee osteoarthritis.

However, the asset failed to demonstrate efficacy in a phase 2 study, with the partners sharing in a 2020 release that “no signal of activity was observed in the topline results.”

Currently, there aren’t any anti-ADAMTS-5 treatments available on the market.