R&D pipeline updates
Opko Health (OPK) is focused on advancing multiple research and development (or R&D) programs including label expansion of Rayaldee and the development of novel therapies in 2018.
On September 4, Opko Health issued a press release announcing the initiation of a Phase 2 trial evaluating Rayaldee in secondary hyperparathyroidism (or SHPT) indication in patients suffering from stage five chronic kidney disease (or CKD) and vitamin D insufficiency. Label expansion could significantly increase Rayaldee’s addressable market size in the US.
Major R&D programs
Opko Health has partnered with Pfizer (PFE) to advance its investigational human growth hormone (or hGH) therapy, Somatrogon, in adult as well as pediatric indications. On August 3, the company released a press release announcing the completion of enrollment of test subjects in a phase three trial comparing weekly treatment with Somatrogon to daily treatment with GENOTROPIN in growth hormone deficient children over a period of 12 months. According to Opko Health’s third-quarter earnings conference call, these children represent almost 80% of the total patient population in the hGH market.
In addition to the potential convenience benefits due to lower dosage frequency, Opko Health also plans to increase ease of administration of the human growth hormone through a pen device. According to Opko Health’s third-quarter earnings conference call, top-line results from this trial are anticipated in the fourth quarter.
According to Opko Health’s third-quarter earnings conference call, the company has also started enrolling patients in a registration study in the pediatric indication that compares Somatrogon with GENOTROPIN, in the Japanese market. The company aims to fully enroll this trial by the end of 2018.
In November 2017, Opko Health issued a press release announcing the initiation of the enrollment of patients in a Phase 2b dose-ranging trial, evaluating its investigational selective androgen receptor modulator (or SARM) therapy in the benign prostatic hypertrophy (or BPH) indication. According to Opko Health’s third-quarter earnings conference call, this trial is expected to complete the enrollment of 110 to 120 test subjects by the end of 2018.