Molecure has not been granted permission to conduct phase II clinical trials for the OATD-01 molecule in patients with active pulmonary sarcoidosis in the European Union and Norway. The company is analysing ways to reapply for authorisation as soon as possible. As stated, one of the reasons for the refusal of the clinical trial authorisation was, in relation to Poland, an additional stringent condition concerning the limitation of the radiation exposure of patients participating in the clinical trial (i.e. the effective dose of radiation) in the course of medical procedures performed during the clinical trial, in particular PET/CT imaging (which is the diagnostic method for the assumed endpoint of efficacy assessment of the studied drug).
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5-day change | 1st Jan Change | ||
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05-17 | Molecure S.A. Reports Earnings Results for the First Quarter Ended March 31, 2024 | CI |
03-22 | Molecure S.A. Announces First Patient in the OATD-01 Phase 2 KITE Study in Pulmonary Sarcoidosis | CI |
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- Molecure S.A Announces No Grant of Permission to Conduct Phase II Clinical Trials for the OATD-01 Molecule I