Somatrogon Phase 3 Pediatric Trial Results will be presented on June 8 at ENDO Online 2020
MIAMI, April 22, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today provided an update on two abstracts regarding the global Phase 3 somatrogon pediatric trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency (GHD). The data from the two abstracts, which were previously accepted for oral presentation at the Endocrine Society’s (ENDO) 2020 meeting, will now be combined into a single presentation at ENDO Online 2020, a virtual event being held June 8 through 22 that will feature on-demand and live programming. The virtual event will incorporate select content from the ENDO 2020 meeting previously scheduled for March 29 through 30 in San Francisco, which was cancelled due to the COVID-19 outbreak.
The results of the pivotal Phase 3 study will be delivered on June 8, 2020 at 11:00 a.m. Eastern time by Dr. Cheri Deal, the Principal Investigator of the Pediatric study. The presentation will be available to those registered for ENDO Online 2020.
The two abstracts entitled “Somatrogon Growth Hormone in the Treatment of Pediatric Growth Hormone Deficiency: Results of the Pivotal Phase 3” and “Interpretation of Insulin-like Growth Factor (IGF-1) Levels Following Administration of Somatrogon (a long-acting Growth Hormone-hGH-CTP)” will be published online in the April-May supplemental issue of the Journal of Endocrinology Society.
On October 21, 2019, OPKO Health and Pfizer Inc. announced that the global Phase 3 trial met its primary endpoint of non-inferiority to daily GENOTROPIN® (somatropin) for injection, as measured by annual height velocity at 12 months.
In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. 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 is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects, as well as statements about expected benefits of hGH-CTP. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Released April 22, 2020