Arecor Therapeutics announces the triggering of a milestone payment from Inhibrx Inc. for a novel enhanced formulation of INBRX-101, developed by Arecor using the company’s patented technology, Arestat, under a license agreement entered into by the two companies in December 2020.
INBRX-101 is an optimised recombinant human AAT-Fc fusion protein, for the treatment of patients with emphysema owing to alpha-1 antitrypsin deficiency (AATD).
AATD is an underdiagnosed inherited orphan genetic disease that can cause serious lung disease in adults and/or liver disease at any age, affecting an estimated 100,000 patients in the United States.
INBRX-101 has the potential to significantly reduce the frequency of annual infusions, eliminate lung decline from Alpha-1 Disease, and could significantly improve patient quality of life compared with the current standard of care.
In March 2022, the US FDA granted orphan-drug designation for INBRX-101 for the treatment of AATD.
On 26 April 2023, Inhibrx announced the initiation of a registration-enabling trial for INBRX-101.1 The initial read-out from the ElevAATe trial is expected to occur in late 2024.
Sarah Howell, Chief Executive Officer of Arecor, said: “This collaboration demonstrates the unique capability of the Arestat technology to deliver superior and novel formulations of complex products, in this case for treatment of an orphan disease."
"It also highlights the strength of Arecor’s licensing model in providing the opportunity to receive near-term revenues from milestone payments and future significant revenue upon commercialisation, bringing long-term value to the company and our shareholders."
"Inhibrx is an excellent partner and we are delighted with the progress made in INBRX-101’s development programme."
"This registration-enabling study may be sufficient to file for regulatory approval under the FDA’s Accelerated Approval Program and is an important step in making this much needed medicine available to patients with AATD.”