OncoArendi Therapeutics announced today that it has filed a Clinical Trial Application (CTA)

Warsaw, 2017/07/07

OncoArendi Therapeutics announced today that it has filed a Clinical Trial Application (CTA) with The Federal Institute for Drugs and Medical Devices (BfArM) to conduct a Phase 1, First-in-Human, study with OATD-01, a potent dual inhibitor of Acidic Mammalian Chitinase (AMCase) and Chitotriosidase (CHIT1). OATD-01 is the first drug candidate targeting members of the chitinase family to enter clinical development. The single dose escalation study is designed to assess the safety, tolerability and pharmacokinetics of OATD-01 in healthy subjects.

OATD-01 is a non-steroidal small molecule inhibitor, which has shown excellent pharmacokinetic properties in three species after oral dosing, and the overall DMPK profile that is consistent with the targeted once-a-day oral dosing in humans. OATD-01 demonstrated significant efficacy in standard mouse models of asthma with anti-inflammatory activity equivalent or superior to montelukast (Singulair), the only approved oral drug for asthma. The results of recently completed GLP toxicology studies fully support further clinical development of OATD-01.

“We are extremely pleased to have completed this significant milestone as we continue to make progress with the development of our novel anti-inflammatory and antifibrotic treatment solutions,” stated Marcin Szumowski, President & CEO of OncoArendi Therapeutics. “We believe that therapies targeting members of the chitinase family have great potential to be transformational medicines in the treatment of several chronic inflammatory diseases.  At OncoArendi, we are dedicated to research and development of innovative therapies that could significantly advance our understanding and treatment of serious inflammatory and fibrotic diseases such as asthma, IPF, sarcoidosis, or COPD,” he continued.

Stanisław Pikul, OncoArendi’s VP of Development, commented “We are particularly excited about the therapeutic potential of OATD-01. Initiation of clinical trials is a key step towards bringing this novel drug candidate to the market as quickly as possible. Data from non-clinical studies suggest that our first clinical candidate can offer an alternative or complementary treatment to the corticosteroid-based asthma therapies such as Advair or Symbiocort. OATD-01 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.”

Based on current projections the initial dosing of OATD-01 is expected to begin in a specialized clinical pharmacology unit in Germany in Q4 this year.

About Chitinase Science

AMCase has been shown to be upregulated during different inflammatory diseases. Its increased levels and activity were reported in airway inflammation induced by allergens in different mouse in vivo models. In humans, patients suffering from allergic diseases, including asthma, have been shown to produce increased amounts of AMCase. The second enzymatically active protein – CHIT1 is involved in development of lung fibrosis. Patients with interstitial lung diseases e.g. IPF or sarcoidosis, and COPD have strongly increased CHIT1 activity that correlates with disease severity. Accumulating evidence indicates that both enzymes are involved in the regulation of pulmonary inflammation and fibrosis-associated airway remodeling during asthma making them attractive therapeutic targets for novel drugs.

About OncoArendi Therapeutics

OncoArendi Therapeutics is an innovative biopharmaceutical company dedicated to developing and commercializing novel therapeutics for inflammatory diseases and cancer. OncoArendi 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), sarcoidosis, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD), as well as tropical diseases and some types of cancer.

Contact information:

Stanislaw Pikul
VP Development
e-mail: s.pikul@oncoarendi.com

Marcin Szumowski
President & CEO
e-mail: m.szumowski@oncoarendi.com

OncoArendi Therapeutics, SA
Zwirki i Wigury 101
02-089 Warsaw
Poland