ResolutionRx, RespireRx’s business unit focused on pharmaceutical cannabinoids, has entered into a letter of intent with Cantheon Capital in which the company agrees to invest approximately $3.1 million to support clinical trial research and development for a new formulation of dronabinol for the treatment of obstructive sleep apnea.
According to the agreement, each tranche of the investment will be equal to 25% of the clinical trial costs of the cannabinoid program. ResolutionRx represented in the letter of intent that it will incur research and development costs of approximately $16.5 during the performance of research and development, which is expected to occur over approximately two and a half years.
ResolutionRx was formed in Australia on Jan. 11 by RespireRx as an unlisted public company. RespireRx intends to contribute, sub-license, assign or otherwise make available to ResolutionRx, its cannabinoid drug development program subject to certain liabilities. ResolutionRx would then engage in the research and development associated with that program, initially for the development of a new formulation of dronabinol for use in a phase 3 clinical trial and the filing of regulatory approval for the treatment of obstructive sleep apnea.
Dronabinol, a synthetic version of ∆-9-THC, a naturally occurring substance in the cannabis plant, has already demonstrated significant improvement in the symptoms of OSA in two phase 2 clinical trials. OSA is a serious respiratory disorder that impacts an estimated 29.4 million people in the United States and that has been linked to increased risk for hypertension, heart failure, depression, and diabetes. There are no approved drug treatments for OSA.
Because dronabinol is already US Food and Drug Administration (FDA)-approved for the treatment of AIDS-related anorexia and chemotherapy-induced nausea and vomiting, the company believes that its re-purposing strategy would only require approval by the FDA of a 505(b)(2) new drug application, an efficient regulatory pathway that allows the use of publicly available data.
“This financing is a crucial next step in the restructuring of RespireRx and the founding and funding of ResolutionRx,” says Arnold Lippa, interim CEO and chief scientific officer of RespireRx, in a release. “Combined with the previously announced debt facility similar to a line of credit to be provided by Radium Capital to finance ResolutionRx’s anticipated 43.5% tax credit under the Australian Research and Development Tax Incentive, the Cantheon financing will provide a significant amount of the funds needed in order for ResolutionRx to conduct the upcoming research and development activities necessary for the commercialization of its pharmaceutical cannabinoid platform.”