Submission of the application for the approval to initiate Phase 1b clinical trial for OATD-01
On October 30, 2018, OncoArendi Therapeutics has requested the German State Institute for Medicines and Medical Devices [BfArM] to start a phase 1b clinical trial for the OATD-01 compound, which will consist of repeated administration of the candidate drug to healthy volunteers in order to evaluate the safety and pharmacokinetics of the compound.
The transition to phase 1b is the next planned step of OATD-01 compound development. The previous part of clinical trials – phase 1a was finally completed in September 2018.
Phase 1b involves safety and tolerability study of the drug administered repeatedly to healthy volunteers in order to determine the range of acceptable doses that can be used in Phase II clinical trials.
Successful completion of the first phase will confirm the safety of the drug and the possibility of transition to the second phase of clinical trials with patients, with the aim of preliminary demonstration of the therapeutic efficacy of the drug candidate.
The company assumes that 36 healthy volunteers will take part in the entire phase 1b study and its predictable duration will be several months.
The clinical part (phase 1a and 1b) of the OATD-01 compound development is carried out as part of the project „Pre-clinical and clinical trials of the candidate for an innovative drug in the therapy of asthma and inflammatory bowel diseases” co-financed by the National Center for Research and Development under the Intelligent Development Operational Program 2014 -2020.
The initiation of the phase 1b clinical trial for the OATD-01 compound also requires the parallel approval of the Bavarian Ethics Committee. A proposal in this regard will be sent to this Ethical Committee today.