Molecure Receives Positive IDMC Recommendation to Continue the KITE Clinical Trial Without Changes to the Study Protocol (OATD-01 Development Program)

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Molecure Receives Positive IDMC Recommendation to Continue the KITE Clinical Trial Without Changes to the Study Protocol (OATD-01 Development Program) The Independent Data Monitoring Committee (IDMC) recommended continuation of the global Phase II PoC study in patients with active pulmonary sarcoidosis without changes to the current protocol.The recommendation followed the IDMC’s review of the complete safety and efficacy dataset for an interim analysis in 30 patients.Based on unblinded data, a futility analysis indicated sufficient probability of achieving the primary endpoint—based on differences in PET/CT imaging—and selected secondary endpoints.Preliminary biomarker analysis of blinded data showed inflammatory biomarker trends consistent with OATD-01's expected biological response.Molecure is currently randomizing 20 additional patients for the second and final interim analysis, which will involve a statistical re-evaluation of the required trial size.The positive recommendation should boost patient recruitment and ongoing business development discussions for the accelerated development of OATD-01.. WARSAW, Poland, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Molecure S.A. (WSE: MOC), a clinical-stage biotechnology company, has received a positive recommendation from the IDMC to continue the Phase II KITE clinical trial without protocol changes. The trial evaluates the efficacy and safety of OATD-01, a first-in-class CHIT1 inhibitor, in active pulmonary sarcoidosis patients. The IDMC reviewed data collected following the 12-week treatment period for the first 30 patients receiving either OATD-01 or a placebo, recommending that the trial continue in its current form. “The IDMC recommendation is highly reassuring at this stage. The Committee recommended that KITE continue without any changes to the protocol, which suggests that the study has a good chance of achieving its primary efficacy endpoint and meets the required safety criteria," said Dr. Marcin Szumowski, CEO of Molecure S.A. "From a business perspective, the IDMC recommendation, along with the observed biomarker trends and favorable safety profile, strengthens our position in ongoing partnering discussions following the strong interest we received during the BIO International Convention.” Biomarker analysis is an important component of this early trial stage. The Compan...

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