A Phase 1 Randomized, Placebo-Controlled, Single Ascending Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of cNP8 in Healthy Adults
Abstract
Burns represent 5-20% of all combat-related injuries, 20% of which are considered severe or involve more than 20% of total body surface area, resulting in significant cost of care as well as long-term complications including functional impairment and disfigurement (data from U.S. Army studies). According to the American Burn Association, each year in the United States, 40,000 cases require hospitalization with an estimated annual expenditure of >$2 billion direct costs of care and much greater indirect costs secondary to unemployment (http://www.ameriburn.org/resources_factsheet.php. American Burn Association Incidence Fact Sheet 2016). Burns cause pain for at least three days and this correlates with continuing damage and death to tissue surrounding the burn for as long as three days post-burn. There is no treatment for this progressive tissue damage and death and its accompanying pain. NeoMatrix Therapeutics, Inc. (NMT) in Stony Brook, NY, has developed a drug that limits the progressive tissue damage around a burn and speeds healing. The Defense Medical Research and Development Program (DMRDP) through the Joint Program Committee 2 (JPC-2) Military Infectious Diseases Research Program (MIDRP) and JPC-6/Combat Casualty Care Research Program (CCCRP)/ Battlefield Wound Management and Infection Research (BWMIR) Award has encouraged NMT to submit a proposal to support a phase 1 clinical trial for our drug product, titled A Phase 1 Randomized, Placebo-Controlled, Single Ascending Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of cNP8 in Healthy Adults. This clinical trial proposal is in response to the FY22 DMRDP BWMIR, Focus Area: Understanding combat traumatic wound physiology and wound progression through preclinical and clinical studies to inform clinical practice guidelines and standard of care efficacy and gaps. The clinical trial will test the drug, cNP8 for Injection, for the first time in humans. Preclinical results demonstrate that the drug given at the highest dose planned to be given in the phase 1 clinical trial should not have any side effects, other than possible, transient redness and itching around the site of intravenous injection. Such a phase 1 clinical trial in normal healthy volunteers is required by the FDA prior to use in patients with burns. Even though the cNP8 doses to be tested in humans were well tolerated when administered to animals, it is possible that cNP8 may cause side effects in humans that were not seen in animals. Therefore, volunteers will be monitored for all side effects for the duration of the study. If the phase 1 clinical trial demonstrates the drug is safe in healthy volunteers, the next clinical study will be performed in patients with small burns. If the drug is safe and appears effective in patients with small burns, the drug will be tested in two additional, larger studies in patients with more extensive burns that have admitted to burn centers around the country. The phase 1 clinical trial, once approved and funded, will take approximately 6 months to complete. The follow-up studies will take several years to complete. If cNP8 is successful in limiting burn injury progression, it will provide transformative therapy and a new standard of care for victims of serious burn injury. With this therapy, wounded Warriors would be less likely to suffer immediate or long-term consequences of burn injuries and be more likely to return to duty fully able to serve. More specifically, wounded Warriors, Veterans, and civilians with substantial burn injuries would have decrease suffering, decrease length of hospitalization, decrease need for surgery, and decrease hospital and rehabilitation costs. In the long term, patients should have less functional impairment and less disfigurement from scarring. Furthermore, the time, effort, and stress of family members and caregivers would be greatly decreased due to these burn victims having less pain,
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252311064
Entities
People
- Richard Clark
Organizations
- United States Army