OncoArendi develops OATD-01 as a drug candidate for treatment of severe inflammatory and fibrotic diseases. Clinical trials in patients must be preceded by a number of preclinical safety studies, including GLP standard chronic toxicology. Such studies, outsourced to Charles River (USA), a leading global CRO (Contract Research Organization) have recently completed dosing. The 6 and 9 month period of administration of OATD-01 in rats and dogs (respectively) has just ended. A recovery phase of several weeks is currently ongoing. Preliminary reports of these studies are expected at the end of January 2021, while the final reports will be obtained in the second half of 2021. It should be emphasized that previously completed 17-week toxicology studies, also performed by Charles River, already enable Phase IIa studies in sarcoidosis patients to begin early next year.
“Successful completion of the 6 and 9 month toxicology studies may enable future administration of OATD-01 for indefinite periods of time to patients in diseases, in which blocking of the therapeutic target (chitinases) by the OATD-01 may have a therapeutic effect. One such widespread and as of today uncurable diseases that affects tens of millions of people worldwide is nonalcoholic steatohepatitis (NASH)” – said Dr Rafał Kaminski, Board Member and Chief Scientific Officer, OncoArendi Therapeutics S.A.
OncoArendi has just received new and very exciting results from a preclinical study conducted by Sanyal Biotechnology (USA), a CRO working with a number of leading pharmaceutical companies developing therapies for NASH. The results obtained in the mouse model (DIAMONDTM) clearly indicate that OATD-01 has demonstrated a therapeutic effect by statistically significant reduction of a number of parameters of the disease. Similar effects were observed with another lead compound that shares the same mechanism of action as OATD-01. The results obtained in this model are an independent confirmation of the therapeutic efficacy of OATD-01, observed previously in another mouse model of NASH (STAMTM) by SMC Laboratories in Japan. The convergence and statistical significance of the two experiments highlights the potential of OATD-01 and other chitinase inhibitors in treatment of NASH.
Positive results from both NASH models and the completion of 6-9 month toxicology studies build value and significantly expand the therapeutic potential of compounds developed in the OncoArendi’s flagship Chitinase Platform.
OncoArendi Therapeutics S.A. is an innovative biotech company focused on discovery, development and commercialisation of novel medicines to treat patients with pulmonary diseases and neoplasms. OncoArendi’s business model is based on discovery and development of new therapeutic compounds with the intention to out-license the medicines to pharmaceutical companies. The company develops potential first-in-class or best-in-class medicines for the treatment of diseases associated with unmet medical need. For the development of current research projects OncoArendi Therapeutics has obtained funds from private investors as well as from numerous grants co-financed by national funds, EU funds, Horizon 2020 and the US National Health Institute (NIH) following a competitive procedure. In March 2018 OncoArendi Therapeutics successfully conducted the initial public offering (IPO) which resulted in obtaining 58 million PLN for further development of its biotech projects in the future. The company was first listed on the Warsaw Stock Exchange on 19 April 2018.
For more information visit: https://oncoarendi.com/
Michał Wierzchowski, cc group
tel. +48 531 613 067
Katarzyna Mucha, cc group