OATD-01, a novel inhibitor of chitinases was developed by OncoArendi Therapeutics as an innovative and unique therapy for multiple lung diseases including asthma, idiopathic pulmonary fibrosis and sarcoidosis, as well as other fibrotic diseases such as NASH.
Asthma is a chronic inflammatory lung disease which affects more than 300 mln people worldwide. Despite the availability of antiinflammatory steroidal drugs and bronchodilators, asthma remains an unmet medical need as a significant fraction of patients, particularly with severe asthma, exhibits poor response to treatment.
Interstitial lung diseases is a group of over 300 lung disorders which affects lung interstitium: the most common are sarcoidosis and the idiopathic pulmonary fibrosis. These diseases, many with unknown etiology, are characterized by the alveolar damage which often leads to a chronic inflammation and fibrosis resulting in a diminished lung functions.
The growing evidence from preclinical and clinical studies implicated members of the chitinase family, acidic mammalian chitinase (AMCase) and chitotriosidase (CHIT1), in pathology of multiple interstitial lung diseases and asthma providing a rationale for a therapeutic targeting of these enzymes.
Following a rational design and synthesis of over 1000 compounds, OncoArendi has developed a first-in-class therapeutic product for asthma treatment, the clinical candidate OATD-01. This is the first chitinase inhibitor to have entered pre-clinical and clinical development.
OATD-01 has certain unique features:
- Novel, efficacious and safe, non-steroidal small molecule inhibitor strategy to treat asthma by targeting the key pathways involved in airway inflammation
- Dual anti-inflammatory and anti-fibrotic activity through inhibiting chitinases with a single NCE in the in vivo model of airway inflammation induced by house dust mite
- Anti-fibrotic therapeutic efficacy in the bleomycin-induced lung fibrosis model and the STAM model of non-alcoholic steatohepatitis
- Oral delivery significantly improving patient compliance, once-a-day dosing (supported by animal PK studies in three species)
- Proprietary IP (two US patents granted, three pending in national validation & PCT phase)
Program is currently in the clinical development.