The Theravance biopharmaceutical drug as the core of the intestinal disease research alliance has been Failure The Phase 2 dose exploratory study of ulcerative colitis casts doubt on the drug’s prospects in this indication or any other indication.
In 2018, Johnson & Johnson subsidiary Yangsen Biotechnology $100 million paid to Theravance Start the partnership in advance and promise to provide another 900 million dollars to achieve the milestone. The most advanced of these procedures is idencitinib, an oral medication designed to block the janus kinase (JAK) enzyme that plays a role in inflammation.
So-called JAK inhibitors have entered the market for autoinflammatory diseases, such as rheumatoid arthritis. Theravance operates between Dublin and South San Francisco, focusing the development of idencitinib on the intestines, with inflammatory bowel disease and ulcerative colitis as the main indications. The drug is designed to target its effects to the intestines, which is a potentially important feature, because JAK inhibitors currently on the market circulate throughout the body, causing side effects, including cardiovascular problems and infections.
The Phase 2 study enrolled 239 patients who were randomly assigned to a group receiving one of three doses of Theravance drug or a placebo, once a day for eight weeks. The main goal of the study was to show changes in the scale used to assess the severity of ulcerative colitis compared to placebo. Theravance reports that with this measure, there is no improvement in any dosage. The clinical response increased slightly in a dose-dependent manner, which the company said was due to a decrease in rectal bleeding.
Theravance said that all three doses were well tolerated by patients. The incidence of adverse events was similar in the treatment group and the placebo group. There are no reports of intestinal perforation, opportunistic infections or major cardiovascular problems.
Theravance Said It will analyze the results to better understand them and what they mean for the future of idencitinib. The company is still waiting for the 16-week and 44-week research results. Theravance plans to present the research results at future scientific conferences. According to data on ulcerative colitis, Theravance stated that it will minimize future spending on idencitinib.
The disappointing data on ulcerative colitis means that the best remaining vaccine for idencitinib is Crohn’s disease. The second phase of the study is underway. Theravance expects preliminary data to be released later this year or early 2021.
Theravance’s most advanced project is ampuloxetine, an experimental treatment for symptomatic neurogenic orthostatic hypotension. The wholly-owned drug is in phase 3 testing.
Photo: TLFurrer, Getty Images
