ResolutionRx Ltd, a subsidiary of RespireRx Pharmaceuticals Inc focused on developing a dronabinol-based drug to treat obstructive sleep apnea (OSA), entered into a master services agreement with Ab Initio Pharma Pty Ltd to manufacture, formulate, test, and supply ResolutionRx with drugs based on lipid nanoparticle technology licensed from RespireRx.
The initial services relate to ResolutionRx’s repurposing of dronabinol and its development program for OSA pursuant to which Ab Initio will, among other things, manufacture and test a new dronabinol lipid nanoparticle formulation for pharmacokinetic, pharmacodynamic, and pivotal clinical trials, as well as ultimately for commercialization.
The initial term of the MSA is two years and automatically renews for one-year periods.
“The importance of this partnership cannot be overstated,” says Arnold Lippa, PhD, co-CEO and chief scientific officer of ResolutionRx and CEO and chief scientific officer of RespireRx. “With its formulation expertise and GMP manufacturing facilities, Ab Initio will complete our original laboratory experiments to determine a final, optimum dronabinol formulation, scale up, and manufacture the chosen formulation for clinical use. The lipid nanoparticle technology not only represents a major step forward in the development of dronabinol but the potential for more widespread use for insoluble or poorly soluble drugs.”
ResolutionRx was formed in Australia in January 2023 by RespireRx. RespireRx has contributed by sublicense and license with ResolutionRx, its sleep apnea drug development program subject to certain liabilities. ResolutionRx will now 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 OSA.
Dronabinol, an endocannabinoid receptor agonist, has already demonstrated significant improvement in the symptoms of OSA in two phase 2 clinical trials.
Because dronabinol is already US Food and Drug Administration (FDA)-approved for the treatment of AIDS-related anorexia and chemotherapy-induced nausea and vomiting, RespireRx and ResolutionRx believe that its repurposing strategy would only require, in the United States, approval by the FDA of a 505(b)(2) new drug application, an efficient regulatory pathway that allows the use of publicly available data.