RespireRx Secures DoD Funding for Phase 2 Trial of CX1739 to Enhance Bladder Function in Spinal Injury Patients

RespireRx Pharmaceuticals Inc., a company dedicated to developing innovative treatments for neurological disorders, has announced that the Department of Defense (DOD) has approved a $1.8 million research grant. This funding will support a clinical study to evaluate the safety and efficacy of CX1739, RespireRx's lead AMPAkine compound, in improving bladder function and motor activity for individuals suffering from spinal cord injury (SCI). The clinical trial will be conducted at the renowned Shirley Ryan AbilityLab in Chicago, overseen by research scientist Dr. Milap Sandhu, with collaboration from RespireRx's Dr. Arnold Lippa and the University of Florida's Dr. David Fuller.

The U.S. Army Medical Research Acquisition Activity is administering the grant through the Spinal Cord Injury Research Program. The awarded sum of $1,793,411 will be directed towards a two-stage Phase 2A/2B clinical study. The Phase 2A segment will involve an ascending single-dose safety and efficacy assessment, while the Phase 2B phase will be a double-blind, placebo-controlled study where participants will receive either CX1739 or a placebo twice daily for seven days.

Neurogenic bladder dysfunction is a prevalent and debilitating complication of SCI, leading to severe urological issues and a diminished quality of life. Current treatment options, often involving catheterization, come with significant risks. The study aims to address this unmet medical need by potentially offering a novel therapeutic avenue through the use of CX1739.

Dr. Sandhu expressed his gratitude for the funding, highlighting the potential of translating positive preclinical results into human trials. If successful, CX1739 could represent a groundbreaking treatment for SCI. Dr. Lippa noted that previous Phase 1 safety trials and Phase 2 proof-of-concept trials have shown promising results for CX1739, reinforcing the compound's target engagement capabilities. He emphasized the significance of this non-dilutive funding in advancing the clinical studies set to begin in late 2024.

RespireRx is focused on pioneering treatments for psychiatric and neurological disorders, affecting millions of people worldwide. Their drug development pipeline includes neuromodulators like AMPAkines and GABAkines, as well as pharmaceutical cannabinoids. The company's lead compounds, CX717 and CX1739, have demonstrated potential in clinical applications for conditions such as SCI, ADHD, epilepsy, and pain management.

AMPAkines, which modulate AMPA-type glutamate receptors, have shown positive outcomes in animal models of ADHD and SCI, with CX717 exhibiting significant symptom improvement in a Phase 2 trial for ADHD. Additionally, GABAkines, under license from the University of Wisconsin-Milwaukee Research Foundation, have shown efficacy in animal models of epilepsy, pain, anxiety, and depression, without common side effects like sedation or motor impairment.

The company's subsidiary, ResolutionRx Ltd, is focused on developing a new formulation of dronabinol for obstructive sleep apnea (OSA), a condition affecting millions worldwide. Dronabinol has already shown efficacy in Phase 2 trials and benefits from an efficient regulatory pathway for repurposing approved drugs.

RespireRx's commitment to advancing research and development through strategic partnerships and innovative drug platforms seeks to address significant unmet medical needs, offering hope for improved treatment options for various neurological and psychiatric conditions. The company's efforts underscore the importance of translational research in bridging the gap between preclinical findings and clinical applications, potentially leading to groundbreaking therapies that can significantly enhance the quality of life for patients with debilitating conditions.