The Bill & Melinda Gates Foundation has awarded Acorda Therapeutics Inc a $1.4 million grant to support the development of a formulation and delivery system for a dry powder version of lung surfactant, a drug used to treat neonatal respiratory distress syndrome (RDS).
The formulation will be based on the company’s proprietary ARCUS technology, and will be produced in collaboration with the Massachusetts Institute of Technology (MIT).
RDS is a condition affecting newborns in which fluid collects in the lungs’ air sacs; it most commonly affects infants born prematurely. It can be fatal, or lead to severe, chronic health issues caused by a lack of oxygen getting to the baby’s brain and other organs. The syndrome is caused by the infants’ inability to produce enough surfactant, a liquid lining the inside of the lungs. Delivering liquid surfactant to the lungs via intubation is the standard of care.
Intubation poses problems in the developing world due to resource and infrastructure limitations, including the need to refrigerate surfactant, access to sterile medical supplies, access to potable water and a lack of healthcare professionals trained in intubation. This grant will support the development of a portable and easily administered inhaled form of surfactant, which may present a more practical alternative for use in developing areas of the world.
“Using the ARCUS technology to develop an inhaled formulation of surfactant has the potential to expand access to this life-saving treatment in developing countries. ARCUS-formulated medications studied to date have been self-administered and stored at room temperature; these features have the potential to eliminate some of the barriers that prevent more widespread use of surfactant to treat infants with RDS,” said Rick Batycky, Chief Technology Officer of Acorda Therapeutics. “The ARCUS technology has a wide range of potential applications. With the support of the Gates Foundation, we’re excited to explore this technology to improve health outcomes for infants in areas with constrained healthcare infrastructures. ”
“Some of the early research that led to the ARCUS technology was conducted at MIT, so it’s very gratifying to see its continued development,” said Robert Langer, Ph.D., David H. Koch Institute Professor of the Massachusetts Institute of Technology. “We’re excited that it has the potential to help newborns with RDS, where there is a significant unmet medical need.”
ARCUS technology is used in CVT-301, an inhalable form of levodopa being investigated by Acorda in Phase 3 trials to treat OFF episodes in people with Parkinson’s disease. It has also been used in formulating CVT-427, a treatment for migraines in preclinical testing. The ARCUS technology has been used to successfully deliver more than one million doses to patients in clinical trials of various products.