Curacle “Retinal Disease Treatment with Returned Rights, Independently Developed”

Curacle announced that it will continue to independently develop ‘CU06’, a candidate substance for the treatment of macular edema.

Curacle announced on the 18th that it has completed all negotiation procedures with French pharmaceutical company ‘Thea Open Innovation’ regarding the return of rights to CU06 and has received back all rights, including development rights and global distribution rights.

In 2021, Curacle transferred the global rights to CU06 to Thea. At the time, the contract size was approximately KRW 183.7 billion, including an advance payment of KRW 7 billion. However, in May, Thea decided to return the rights, and CU06 returned to Curacle.

On the positive side, the return of the rights to Thea is not due to the clinical failure of CU06. CU06 met both the primary and secondary endpoints in the US phase 2a clinical trial. In particular, the retinal thickness of diabetic macular edema patients who took CU06 orally once a day for 12 weeks was maintained, and the best corrected visual acuity also improved. This means that it can help prevent the progression of macular edema and improve vision.

The clinical results of CU06 have received positive evaluations from the global scientific advisory board and research team, and in particular, the innovation and importance of the clinical results were recognized at the recent American Society of Retina Research (ASRS) annual conference, Curacle explained.

Based on the successful clinical results, Curacle plans to accelerate its own development. A Curacle official said, “We have been preparing for clinical trials without a hitch in preparation for the situation where we will independently conduct follow-up clinical trials for CU06,” and “With the return of rights, we will be able to communicate transparently about our future plans.”

The official added, “Currently, the selection of a global clinical trial contract organization is in the final stages, and we are also coordinating the production schedule for new formulations to be used in clinical trials with a local company in the U.S. We plan to discuss future regulatory matters related to CU06, such as the progress of clinical phases 2b and 3, and the drug approval process, with the U.S. Food and Drug Administration (FDA).”