Ono cans 2 endocannabinoid drug studies after quintuple Phase 2 failure

Target, miss the target, target shooting, dart, correct decisions, bow and arrow, dart on target, hits and misses (3d illustration)

Ono Pharma’s ONO-1110 failed five Phase 2 trials, leading to the discontinuation of development in depression and social anxiety. Work will continue for three pain indications.

Ono Pharma’s endocannabinoid modulator showed no effect in easing depression and social anxiety disorder during a group of Phase 2 trials but appeared to show a glimmer of hope for reducing pain.

The Japanese company is discontinuing development of ONO-1110 in the first two indications while pursuing the asset’s use in treating pain associated with postherpetic neuralgia (PHN), fibromyalgia (FM) and Hunner-type interstitial cystitis (HIC), according to a Thursday press release.

The decision follows results from five mid-stage studies that Ono was running for ONO-1110. The company offered little detail on the failure beyond saying that there were no efficacy signals in the depression and anxiety trials.

The pain studies were also unsuccessful, with all three missing their primary endpoints, Ono reported. Nevertheless, Ono was encouraged by improvements in pain scores and is planning additional clinical trials to test whether the drug can find a use in certain pain indications.

Ono reported fiscal second quarter earnings on Thursday, including product sales of about $431 million—$5 million ahead of consensus. But the negative pipeline news dragged down sentiment for the drugmaker, Jefferies said in a Thursday note.

Besides the quintuple failure, Ono also discontinued a Phase 1 candidate called ONO-4578 for non-small cell lung cancer. The asset will continue in a Phase 3 trial for gastric and Phase 2 for colorectal cancer, Jefferies said.

Ono picked up Romvimza—previously known by its active ingredient vimseltinib—from its $2.4 billion acquisition of Deciphera Pharmaceuticals in April 2024.

Annalee Armstrong is an award-winning biopharma journalist covering the business of drug development. She has been a journalist for more than 18 years, covering the pharmaceutical and biotech industry for the last eight. She is senior editor at BioSpace and curates the Biopharm Executive newsletter every Wednesday. You can reach her at  annalee.armstrong@biospace.com. Follow her on LinkedIn.
MORE ON THIS TOPIC