Partnership to Advance in Testing OATD-01, Potential IPF Therapy

Galapagos and OncoArendi Therapeutics have entered into an exclusive agreement for the global development and commercialization of OncoArendi’s OATD-01, an investigational treatment for idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases.

Lung diseases like IPF are characterized by increased activity of enzymes called chitinases, which are involved in multiple fibrosis (scarring)-associated processes, including tissue remodeling and inflammation. OATD-01 is an inhibitor of these enzymes.

This potential therapy has shown promising anti-fibrotic effects at doses relevant for treatment in preclinical animal models of pulmonary fibrosis. Mice in this disease model were treated with either OATD-01 or Ofev (nintedanib), an established IPF therapy,  and results showed “comparable” effectiveness, its researchers wrote, supporting further development.

“Converging human biology and preclinical data indicate that chitinases are highly relevant therapeutic targets for a range of inflammatory and fibrotic diseases,” Marcin Szumowski, CEO of OncoArendi, said in a press release.

OncoArendi has developed a portfolio of chitinase inhibitors, with OATD-01 being the first-in-class frontrunner. Phase 1 studies of its safety profile in healthy volunteers found OATD-01 to be well-tolerated, with no serious adverse events reported. Data also suggested that the therapy reduced chitinase activity, supporting its proposed mechanism of action, the company announced in April.

With this agreement, Galapagos has acquired global research, development and commercialization rights to OATD-01. OncoArendi will receive an upfront payment of €25 million (about $30 million), with the possibility of additional payments if developmental and commercial milestones are met.

Galapagos has also secured rights to first negotiation for other products developed via OncoArendi’s chitinase platform.

“OncoArendi is excited about the ability to tap into the scientific and clinical development expertise of Galapagos and we enthusiastically look forward to this long-term strategic collaboration in maximizing the potential of chitinase and chitinase-like proteins in treatment of severe human diseases involving organ fibrosis,” Szumowski said.

OncoArendi remains responsible for all research and development work until the selection of preclinical candidates.

“Bringing OATD-01 to our pipeline supports our ambition to lead the advancement of treatments in fibrosis and continues to show our commitment to push boundaries in the fight against IPF, a debilitating and fatal disease,” said Walid Abi-Saab, chief medical officer of Galapagos.