Development of a Field-Use Therapeutic for Pulmonary Injuries from Trauma or Chemical Exposure
Abstract
This proposal to the Peer Reviewed Medical Research Program is based on the stated interest in supporting novel therapeutic development efforts for Respiratory Health (Fiscal Year 2022 (FY22) PRMRP Topic Area) and, in particular, the development and testing of novel treatments to slow progression or reverse lung injury/disease (FY22 PRMRP Strategic Goal). Acute lung injuries (ALI) arise from a wide variety of causes including infection, inhaled chemicals, major surgery and traumatic injury. Patients with ALI often worsen to acute respiratory distress syndrome (ARDS), which can be life-threatening. For patients that survive ALI/ARDS, there are also significant risks of long-term breathing difficulties, as well as difficulties in performing activities of daily living. In fact, only 50% of patients that develop ARDS return to work within one year. Currently, doctors do not have any therapeutic options that reduce the incidence and long-term consequences of ARDS. Ceria Therapeutics (Ceria) is developing a drug (CTX-002) to treat patients with ALI/ARDS regardless of cause. The first use for this drug is patients in the hospital who have progressed to ARDS and need intensive care and mechanical ventilation. This proposal is to support development of a second formulation of CTX-002 as a powder to be inhaled, termed CTX-002-DPI. This product will be used outside of the intensive care setting by Warfighters and industrial workers (self-administered) and first-responders as well emergency department personnel for ALI arising from trauma or inhaled chemicals. CTX-002-DPI is intended to reduce the chance that a patient with ALI progresses to ARDS. To accomplish this objective we are proposing to freeze-dry the active ingredient in CTX-002 and incorporate it into a commercially-available personal inhaler. We will use industry standard methods to be certain the device dispenses the drug properly and can do so at different temperatures and at altitudes where people live and work. We will also confirm that the delivered drug is effective as a preventative treatment for ALI/ARDS in animal studies. After prototyping, testing, and refining the product, CTX-002-DPI will be presented to the U.S. Food and Drug Administration (FDA) for their input about the design of manufacturing and testing processes. The product will then be manufactured to a standard suitable for testing in patients. We will then present the final documentation to the FDA for consent to begin conducting such clinical testing. This program is expected to result in a product intended to treat ALI that is ready for clinical studies. The long-term impact of developing CTX-002-DPI will be the first preventative treatment for ALI to reduce the chances of progression to ARDS in people who have inhaled a dangerous chemical or been involved in a traumatic accident.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310966
Entities
People
- David R. Jackson
Organizations
- United States Army