RespireRx Pharmaceuticals Gets DoD Grant for Phase 2 CX1739 Study

RespireRx Pharmaceuticals, Inc., based in Glen Rock, New Jersey, announced a significant development in its ongoing research efforts. The United States Department of Defense (DOD) has provided a $1.8 million grant to the Shirley Ryan AbilityLab for a two-stage clinical trial to evaluate the safety and efficacy of CX1739, an AMPAkine compound, for enhancing bladder function and motor activity in patients with spinal cord injury (SCI). This initiative is a collaborative effort involving Dr. Milap Sandhu from Shirley Ryan AbilityLab, Dr. Arnold Lippa from RespireRx, and Dr. David Fuller from the University of Florida.

The clinical study, funded by the DOD's Spinal Cord Injury Research Program under Award No. HT94252410497, will be managed by the U.S. Army Medical Research Acquisition Activity. Dr. Sandhu will lead the trials at Shirley Ryan AbilityLab, which has been recognized as the top rehabilitation hospital by U.S. News & World Report since 1991. The funding will cover the clinical study expenses, with $252,200 allocated to RespireRx for manufacturing and formulating the clinical materials and updating the investigational new drug application (IND) for CX1739. The clinical trial is set to commence by the fourth quarter of 2024, starting with a Phase 2A single ascending dose study, followed by a Phase 2B double-blind, placebo-controlled study over seven days.

Traumatic SCI often results in neurogenic bladder dysfunction, a condition that significantly affects the quality of life and increases the risk of premature death. Current treatments typically involve catheterization, which poses several risks and complications. The global incidence of SCI varies significantly, with neurogenic bladder dysfunction observed in a majority of cases. The new clinical trials aim to address this critical issue.

Dr. Sandhu expressed gratitude for the government funding, highlighting the potential of CX1739 to offer a novel treatment for SCI if it replicates the positive outcomes seen in preclinical studies. Dr. Lippa, CEO and CSO of RespireRx, emphasized that CX1739 has already demonstrated safety and efficacy in Phase 1 and Phase 2 trials, showing promise for treating SCI. He also acknowledged the valuable collaboration with Dr. Fuller, whose research has showcased improvements in motor nerve activity and muscle function in animal models.

RespireRx Pharmaceuticals, through its subsidiary EndeavourRx, focuses on developing treatments for psychiatric and neurological disorders, including epilepsy, pain, ADHD, SCI recovery, and obstructive sleep apnea (OSA). Their research spans two drug platforms: neuromodulators, such as GABAkines and AMPAkines, and pharmaceutical cannabinoids, like dronabinol.

AMPAkines, including CX717 and CX1739, have shown potential in treating CNS-driven disorders, ADHD, and SCI. They have completed several clinical trials, indicating their ability to improve motor functions and counteract opioid-induced respiratory depression. GABAkines, licensed from the University of Wisconsin-Milwaukee, have demonstrated efficacy in animal models for various conditions, including epilepsy and pain, with reduced side effects compared to traditional treatments.

ResolutionRx, another subsidiary, focuses on developing a new formulation of dronabinol for treating OSA. Dronabinol has already shown significant improvements in OSA symptoms in Phase 2 trials. The program's budget is set at $16.5 million, with a significant portion expected to be eligible for the Australian R&D Tax Incentive. Given its existing FDA approval for other uses, the pathway for regulatory approval is streamlined.

Overall, these initiatives underscore RespireRx's commitment to pioneering innovative treatments for conditions with limited or inadequate existing options, potentially transforming patient care in several critical areas.