Inside information: Orion terminates ODM-111 development program due to narrow therapeutic window of the molecule

Orion Corporation has decided to terminate the ODM-111 development program based on the risk-benefit analysis on the results of a longer non-clinical toxicology study. Recent findings indicate that the profile of the ODM-111 molecule does not support long-term use of ODM-111 and progression to later-stage development. Additionally, it is important to note that both prior non-clinical studies and the clinical Phase I trial with shorter durations of exposure to ODM-111 did not reveal any significant safety concerns.

“Although preparations for the Phase II trials were already well underway, we have now evaluated that the therapeutic window of ODM-111 is too narrow and continuation of the clinical development program for ODM-111 is not feasible for Orion. We are now focusing our resources on other promising projects in our R&D pipeline”, said Outi Vaarala, Senior Vice President, Innovative Medicines and Research & Development at Orion.

Exceptionally, Orion publishes information about a project in early clinical development stage in a stock exchange release, because in this case, the information is estimated to meet the definition of inside information due to ODM-111’s strategic importance. This does not affect Orion's current disclosure policy, according to which Orion publishes information on its R&D projects mainly in its interim reports and/or press releases, but, as a main rule, provides information on the results of clinical Phase III trials in separate stock exchange releases.

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion's net sales in 2023 amounted to EUR 1,190 million and the company had about 3,600 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki.