The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Inspirex Lung, Xylyx Bio’s lead investigational candidate for the treatment of lung failure requiring lung transplantation.
The company also announced it was awarded a US $2.99 million Small Business Innovation Research grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to support translational development and clinical evaluation of Inspirex Lung.
Lung transplantation can be lifesaving for patients with end-stage lung disease, yet more than 75% of donor lungs go unused, often due to acute, reversible injury. Approaches that can repair and restore donor organs could make more lungs available to the patients who need them. Xylyx Bio’s proprietary XC Platform uses xenogeneic cross-circulation to provide systemic physiologic support to injured donor lungs to restore them to meet standard transplant criteria, resulting in Inspirex Lung, a human whole-lung graft for clinical transplantation.
Xylyx Bio’s translational work using xenogeneic cross-circulation for donor lung repair has been demonstrated in preclinical research published in peer-reviewed journals.
FDA Orphan Drug Designation is intended to encourage the development of treatments for rare diseases or conditions affecting fewer than 200,000 people in the United States. Subject to applicable requirements, sponsors of designated products may be eligible for incentives including tax credits for qualified clinical trial expenses, exemption from marketing application user fees, and the potential for seven years of orphan drug market exclusivity following marketing approval.
The NIH direct-to-phase 2 SBIR grant award provides $2,999,266 of non-dilutive funding over two years to support safety and feasibility studies of Inspirex Lung, including first-in-human transplantation studies.
