MIAMI, FL, USA I Augusst 29, 2019 I OPKO Health, Inc. (NASDAQ: OPK) today announced that the last patient has completed the final visit in the Company’s pivotal Phase 3 study evaluating the safety and efficacy of the once weekly somatrogon (hGH-CTP) for treatment of growth hormone deficiency in children. The study enrolled a total of 224 treatment naïve patients from 21 countries who were randomized 1:1 into two arms: once-weekly somatrogon vs. once-daily Genotropin® (somatropin). The primary endpoint of the trial is height velocity at 52 weeks. Secondary endpoints are safety and pharmacodynamic endpoints. The clinical safety and efficacy data are currently in the process of being compiled and validated prior to data base lock. Top line results are expected to be announced in the fourth quarter of 2019.
Patients who completed the Phase 3 study had the option to enter an open label extension study to evaluate the long-term safety of somatrogon. Approximately 95% of the patients switched into the open label extension study and receive somatrogon treatment.
“We are pleased to report the completion of the somatrogon pivotal study, an important milestone in the development of once weekly somatrogon. Completion of this study brings us a step closer to potentially providing children with growth hormone deficiency a once weekly treatment,” stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. “We believe that a once weekly treatment could offer a convenient dosing regimen, which by reducing the number of injections could enhance a patient’s adherence to treatment and quality of life.”
In 2014, Pfizer Inc. and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of growth hormone deficiency. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.
About OPKO Health, Inc.
OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is the nation’s third largest clinical laboratory; GeneDx is a rapidly growing genetic testing business; the 4Kscore® prostate cancer test is used to confirm an elevated PSA to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA and testosterone as the most advanced test in development. In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed. OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity recently reported positive data from a Phase 2 clinical trial. It’s among a new class of GLP-1/glucagon receptor dual agonists. OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The company’s most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, is in Phase 3 trials and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad. More information is available at www.opko.com
SOURCE: OPKO Health
Post Views: 90
MIAMI, FL, USA I Augusst 29, 2019 I OPKO Health, Inc. (NASDAQ: OPK) today announced that the last patient has completed the final visit in the Company’s pivotal Phase 3 study evaluating the safety and efficacy of the once weekly somatrogon (hGH-CTP) for treatment of growth hormone deficiency in children. The study enrolled a total of 224 treatment naïve patients from 21 countries who were randomized 1:1 into two arms: once-weekly somatrogon vs. once-daily Genotropin® (somatropin). The primary endpoint of the trial is height velocity at 52 weeks. Secondary endpoints are safety and pharmacodynamic endpoints. The clinical safety and efficacy data are currently in the process of being compiled and validated prior to data base lock. Top line results are expected to be announced in the fourth quarter of 2019.
Patients who completed the Phase 3 study had the option to enter an open label extension study to evaluate the long-term safety of somatrogon. Approximately 95% of the patients switched into the open label extension study and receive somatrogon treatment.
“We are pleased to report the completion of the somatrogon pivotal study, an important milestone in the development of once weekly somatrogon. Completion of this study brings us a step closer to potentially providing children with growth hormone deficiency a once weekly treatment,” stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. “We believe that a once weekly treatment could offer a convenient dosing regimen, which by reducing the number of injections could enhance a patient’s adherence to treatment and quality of life.”
In 2014, Pfizer Inc. and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of growth hormone deficiency. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.
About OPKO Health, Inc.
OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is the nation’s third largest clinical laboratory; GeneDx is a rapidly growing genetic testing business; the 4Kscore® prostate cancer test is used to confirm an elevated PSA to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA and testosterone as the most advanced test in development. In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed. OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity recently reported positive data from a Phase 2 clinical trial. It’s among a new class of GLP-1/glucagon receptor dual agonists. OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The company’s most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, is in Phase 3 trials and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad. More information is available at www.opko.com
SOURCE: OPKO Health
Post Views: 90
