Diurnal Ltd. said it has paused the U.S. development of its hormone deficiency drug Chronocort after the medicine failed to meet its main goal in a phase 3 European trial.
The shares of the Cardiff, U.K.-based specialty pharmaceutical company were down by 12.05% following the news to 36.50 pence as of 2:41 p.m. U.K. time on Oct. 17.
Diurnal was evaluating whether Chronocort was better than conventional therapy in adults with congenital adrenal hyperplasia, or CAH — a group of inherited genetic disorders that affect the adrenal glands. CAH affects the production of one or more of three steroid hormones: cortisol, mineralocorticoids and androgens, such as testosterone.
At the time the results of the European trial were released, the company said it would analyze the phase 3 data plus data from an ongoing study to discuss the development of Chronocort with regulatory authorities. It has now decided to put all development activity of the drug on hold in the U.S. to manage its costs.
The company added that following the analysis of the phase 3 results and data from a safety extension trial, which showed sustained benefit after 12 months of treatment, Diurnal intends to request a scientific advice meeting with European regulators before the end of the year.
The company said it plans to submit an application seeking approval for Chronocort in Europe during the fourth quarter of 2019, including an application for an orphan drug designation to treat CAH.
In addition, the company said it has completed the development program for its other hormonal disorder medicine, Alkindi, for a U.S. approval submission.
Diurnal will seek an end-of-phase 3 meeting with the U.S. Food and Drug Administration to discuss the data for a new drug application submission, which it has planned for the third quarter of 2019.