Initiation of Phase 3 Trials for ODM-208/MK5684 in mCRPC Patients

Orion Corporation and MSD have commenced two significant Phase 3 clinical trials for ODM-208/MK5684, a new CYP11A1 inhibitor, in conjunction with hormone replacement therapy, targeting patients with metastatic castration-resistant prostate cancer (mCRPC). The trials, OMAHA1 and OMAHA2a, are designed to assess the efficacy of this treatment in both front-line and later-line mCRPC patients, including those with and without androgen receptor ligand binding domain (AR LBD) mutations.

Professor Outi Vaarala, Orion's Senior Vice President, highlighted the significance of these trials, emphasizing the potential of ODM-208/MK5684 to provide innovative treatment options for mCRPC patients. Dr. Scot Ebbinghaus from MSD Research Laboratories expressed confidence in the drug's ability to suppress steroid hormone production, a critical factor in prostate cancer progression.

The OMAHA1 trial is an open-label study that will include approximately 1,200 participants globally. It aims to compare ODM-208/MK5684 combined with HRT against alternative new hormonal agents in patients who have previously failed one NHA and one or two taxane-based chemotherapies. The primary outcomes of interest are overall survival and radiographic progression-free survival, differentiated by AR LBD mutation status.

Similarly, the OMAHA2a trial is an open-label Phase 3 study that will enroll an estimated 1,500 patients. It will evaluate the same drug combination in front-line mCRPC patients who have previously failed one NHA, comparing it to the physician's choice of NHA. The primary endpoints for this trial also focus on overall survival and radiographic progression-free survival, with secondary endpoints encompassing time to first subsequent therapy, objective response rate, and duration of response.

ODM-208/MK5684, an oral, non-steroidal, and selective CYP11A1 enzyme inhibitor, is being developed by Orion to treat hormone-dependent cancers such as prostate cancer. It works by inhibiting the enzyme activity, thereby suppressing the production of all steroid hormones and their precursors that activate the androgen receptor signaling pathway.

Metastatic castration-resistant prostate cancer is a severe condition where prostate cancer spreads despite androgen-deprivation therapy. It is estimated that 10-20% of prostate cancer patients develop CRPC within five years, with a high proportion presenting with metastases at the time of diagnosis. mCRPC carries a significant mortality rate, making the development of effective treatments a critical priority.

Orion, a Finnish pharmaceutical company, is dedicated to developing, manufacturing, and marketing human and veterinary pharmaceuticals, as well as active pharmaceutical ingredients. With a focus on oncology and pain, Orion's proprietary products are used to treat various conditions, including cancer and neurological diseases. The company reported net sales of EUR 1,341 million in 2022 and employs approximately 3,500 people. Orion's shares are listed on Nasdaq Helsinki.