Date: 2015-10-13
Type of information: Initiation of preclinical development
phase: 1
Announcement: initiation of preclinical development
Company: OncoArendi Therapeutics (Poland)
Product: OATD-01
Action
mechanism: enzyme inhibitor. OATD-01 is an orally active, non-steroidal small molecule, which is a potent inhibitor of human and murine acidic mammalian chitinase (AMCase). Based upon available information OATD-01 is thought to be the first chitinase inhibitor to enter development. OATD-01 has excellent oral pharmacokinetic characteristics in three species, with high bioavailability, low clearance and high volume of distribution. In addition, OATD-01 has good metabolic stability, moderate plasma protein binding and does not inhibit or activate human cytochrome P450 isozymes. The overall DMPK profile of OATD-01 is consistent with the targeted once-a-day oral dosing in humans. OATD-01 is effective in two standard mouse models of asthma (ovalbumin and house dust mite), with anti-inflammatory activity superior to montelukast (Singulair), the only current oral asthma medicine that is used regularly. OATD-01 has low potential for off-target side effects as demonstrated by a clean profile in the Diversity Profile™ (Eurofins, Cerep) consisting of 98 enzymes, ion channels and receptors, and no significant effect against the hERG channel. OATD-01 is also negative in the Ames mutagenicity test.
Disease: asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On October 13, 2015, OncoArendi Therapeutics announced that it selected OATD-01 as its clinical development candidate for the treatment of asthma. Submission of the Company's first Investigational New Drug application is expected by mid-2017. Activities in support of IND-enabling pre-clinical testing of OATD-01 are already in progress with initiation of first in human studies expected during the second half of 2017. OncoArendi Therapeutics’ AMCase inhibitors, including OATD-01, are protected by three pending patents covering three structurally different groups of compounds.
