Warsaw, Poland, October 13, 2015 / B3C newswire / - On October 13, 2015, OncoArendi Therapeutics Ltd. 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 (“IND”) application is expected by mid-2017.
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.
“We believe that drugs against novel targets from the chitinase protein family have great potential to be transformational medicines in the treatment of several chronic inflammatory diseases. At OncoArendi, we are dedicated to researching and developing first-in-class small molecule-based therapies that could significantly advance our understanding and treatment of inflammation-based diseases such as asthma, IPF, COPD or IBD,” said Marcin Szumowski, PhD, President and CEO of OncoArendi Therapeutics. “We are particularly excited about the potential of our first clinical candidate as an alternative or complementary treatment to the corticosteroid-based asthma therapies such as Advair or Symbiocort. This compound has an excellent safety profile and appears suitable for once-a-day oral dosing, with a completely different molecular target and mechanism of action compared to Singulair.”
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.
About Chitinase Science
Acidic Mammalian Chitinase (AMCase) is one of the enzymes that cleaves chitin - a component of the cell walls of fungi and exoskeletal elements of crustaceans and insects. AMCase has been shown to be induced at sites of Th2-dependent inflammation, including in asthma and represents an attractive, novel target for a small molecule strategy. OncoArendi is working on AMCase inhibitors under a global exclusive license for the initial technology from Yale University. In addition, OncoArendi is conducting research on two other members of the chitinase family, chitotriosidase (Chit1) and chitinase-3-like protein 1 (CHI3L1), also known as YKL-40, which have been shown to play significant roles in numerous diseases.
About OncoArendi Therapeutics
OncoArendi Therapeutics is an innovative biopharmaceutical company dedicated to developing and commercializing novel therapeutics for neoplastic and inflammatory diseases. OAT has broad interest and commitment to chitinase science with three distinct small molecule drug discovery programs directed against different chitinase family targets currently in progress. Potential therapeutic applications for compounds resulting from this R&D Chitinase Platform include treatment of numerous diseases with high unmet medical need, such as idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD), as well as tropical diseases and some types of cancer.
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