Renovion Provides Regulatory Update and Initiation of Clinical Program in Non-CF Bronchiectasis
Renovion, Inc., a clinical-stage pharmaceutical company focused on developing treatments for rare, chronic, and serious lung diseases with high unmet needs, announced today that they have received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial to investigate ARINA-1 in non-cystic fibrosis bronchiectasis (NCFBE). ARINA-1 is a nebulized therapy that thins mucus and enables mucus clearance from the lungs while decreasing pathological inflammation.
NCFBE is characterized by a vicious and chronic cycle of thick, suffocating mucus, inflammation, and infection that results in decreased quality of life. There are no FDA-approved treatment options to decrease mucus viscosity and improve mucus clearance in NCFBE. The ARINA-1 trial will be the first of its kind in this patient population and will enroll from sites across the US.
“The clearance of the IND for ARINA-1 use in NCFBE is a significant regulatory milestone for Renovion that allows us to advance our clinical development strategy. We are excited to start participant recruitment for NCFBE trial in Q2 2022 and continue our clinical development with trials in lung transplant and non-tuberculosis mycobacteria pulmonary disease starting later this year,” said Carolyn Durham, PhD, Chief Scientific Officer of
Renovion is a clinical-stage pharmaceutical company focused on developing ARINA-1, novel nebulized therapy delivered to the lungs to treat pulmonary diseases. ARINA-1 clears mucus and reduces damaging inflammation in the airways to restore lung health. Renovion is poised to start clinical trials in chronic inflammatory airway diseases, including non-cystic fibrosis (CF) bronchiectasis (NCFBE), and chronic obstructive pulmonary disease (COPD). The Renovion team has in-depth experience in drug development with extensive scientific expertise in chronic pulmonary conditions and inflammation. For more information on Renovion, visit https://www.renovion.com/ or follow Renovion on Twitter.
Carolyn Durham, PhD