OncoArendi Therapeutics S.A., an innovative biotechnology company specializing in the quest, development and commercialization of new drugs used in the treatment of inflammatory and cancer diseases, on January 9 2019 received from the German National Institute for Medicines and Medical Devices (BfArM) permission to conduct a 1b phase of clinical trial for the OATD-01 compound.
The phase 1a clinical trials of the OATD-01 molecule, which was first given to humans (First-in Human), were successfully completed last year. The tests were conducted at a specialized center in Germany.
The permission to conduct the study was forwarded by BfArM to the Bavarian Ethics Committee, from which OncoArendi Therapeutics now expects a separate authorization to start phase 1b clinical trials.
We expect that, with the admission from BfArM, the decision of the Ethics Committee will be positive and we will be able to initiate study soon. Phase 1b clinical trials of the OATD-01 molecule will involve repeated administration of increasing doses to healthy volunteers to confirm its safety and lack of significant side effects. The study will be carried out in Germany in the same center where we carried out phase 1a study. Our goal is to complete and summarize the results of Phase 1b research at the turn of the second and third quarter of 2019– says Marcin Szumowski, president and significant shareholder of OncoArendi Therapeutics.
After successful completion of phase 1b for the OATD-01, the next phase of clinical trials is the phase 2 – the administration of the molecule to patients.Its initiation is possible this year. At this stage, we would be in a good position to start project commercialization, i.e. to sign a partnership agreement with a large pharmaceutical company. It is possible, however, that in order to increase project value project, we will decide to sign the license agreement at the time when we have test results confirming the initial therapeutic effect in patients, because it will increase the value of the program– says Marcin Szumowski.
OATD-01 is a new, non-steroidal drug developed by OncoArendi Therapeutics to treat asthma, sarcoidosis and spontaneous pulmonary fibrosis.
Potential therapeutic applications of OATD-01 are rare diseases that are unmet medical needs in the world, such as sarcoidosis and idiopathic pulmonary fibrosis, as well as selected groups of patients suffering from steroid-resistant bronchial asthma. The OATD-01 compound can inhibit the inflammatory process in the airways and the process of tissue changes leading to their fibrosis. Thanks to this, it can be a chance for treatment for those patients in whom previous therapies have been ineffective or for which drugs have not been developed so far.
More details are available from:
Michał Wierzchowski, cc group
phone +48 531 613 067
e-mail: email@example.com **
Contact for investors:
Katarzyna Mucha, cc group
tel. +48 697 613 712