The signal it received was the U.S. Patent and Trademark Office completing a review of its new patent application for the cortisol synthesis inhibitor. The second patent, which would expire Jan. 10, 2026, would cover other conditions in addition to Cushing’s.
Strongbridge’s first patent on Recorlev came in December 2015. It covers the therapy’s ability to reduce C-reactive protein levels and inflammation. It will expire Dec. 29, 2030.
“The patent scheduled to issue from this [second] application should result in additional intellectual property protection for Recorlev, potentially extending our drug candidate’s patent term beyond orphan drug exclusivity and enhancing the overall Recorlev patent portfolio,” Matthew Pauls, president and chief executive officer of Strongbridge Biopharma, said in a press release. An orphan drug is one used to treat rare diseases.
“This marks an important step in our ongoing efforts to optimize the value of Recorlev and further strengthens Strongbridge’s leadership position in rare endocrine disease,” Pauls added.
Strongbridge developed Recorlev to treat the elevated levels of the hormone cortisol that are associated with Cushing’s syndrome. It received orphan drug designations from the U.S Food and Drug Administration and European Medicines Agency as a treatment for endogenous Cushing’s syndrome.
Meanwhile, Strongbridge is evaluating Recorlev’s safety and effectiveness in the open-label SONICS Phase 3 clinical trial (NCT01838551) and in the placebo-controlled LOGICS Phase 3 trial (NCT03277690) in adults with Cushing’s.
Researchers are still recruiting patients for the LOGICS study. They plan to enroll 40 patients at 40 sites globally.
The trial will be divided into three parts. Part A will evaluate the effectiveness and safety of increasing doses of Recorlev. In Part B, participants will be randomized to continue receiving Recorlev or go to a placebo. In Part C, both groups will receive Recorlev and a placebo at the same time.