Curacle presents results of its phase 2a clinical trial of CU06 for DME

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Curacle presented the results of its phase 2a clinical trial of CU06 for diabetic macular edema (DME) at the 4th Asia Retina Congress. This meeting is being held alongside the 2024 Annual Meeting of the Korean Retina Society in Seoul.

The trial of this oral medication, which involved 67 DME patients in the US over a three-month period, showed improvements in best corrected visual acuity across all dosing groups (100, 200, and 300 mg). The 300 mg group, consisting of patients with relatively low vision, experienced a maximum improvement of 5.8 letters. Higher doses and longer administration periods were associated with greater improvements. Central subfield thickness remained stable, and post-hoc analysis showed dose-dependent improvements in anatomical markers like retinal fluid and photoreceptor damage. No serious adverse events related to the drug were reported, confirming its safety.

Professor Woo Se-jun of the Department of Ophthalmology at Seoul National University Bundang Hospital presented the trial results. In the news release, Woo said, “CU06 likely improved vision by targeting both exudate (edema) and non-exudate mechanisms. Given the improved vision with higher doses and longer treatment periods, a phase 2b trial is being planned.”

Curacle plans to finalize its development strategy, including phase 2b and 3 trials, through a Type C meeting with the US FDA in February of 2025. The company expects this meeting to clarify its development strategy, potentially accelerating licensing discussions with partners and marking a key milestone for CU06's commercial success.

Reference:

1. Curacle presents positive phase 2a results for CU06 at Asia Retina Congress. Curacle. December 18, 2024. Accessed December 18, 2024. https://www.koreabiomed.com/news/articleView.html?idxno=26068