ResolutionRx Ltd (Australian Company Number a/k/a ACN 664 925 651) was formed in Australia on 11th January 2023 by RespireRx as an unlisted public company for the purpose of discovering and developing medicines for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of people, but for which there are few or poor treatment options, including sleep related breathing disorders such as obstructive sleep apnoea (“OSA”).
ResolutionRx has chosen to use alternative, innovative methods in order to bring drugs to market faster, cheaper and with less risk. One of these methods is to circumvent the very costly and time consuming drug discovery stage by repurposing known drugs for new uses and re-evaluating known drug development programs that have not been successful and are no longer the focus of other, larger pharmaceutical companies. Frequently, important information regarding drugs, neuronal substrates and mechanisms of drug action that is publicly available can guide a drug acquisition program to acquire overlooked drug programs or determine new uses for existing drugs. We believe that considerable value still exists in many already approved drugs that are off their original patents and terminated research programs if proper analyses are made concerning the reasons for their demise. In particular, we believe that value can be found using the concepts of “rediscovery” and “repurposing.
RePurposing - a process whereby value can be found by (a) determining that an identified neuronal substrate is involved in an undiscovered or little know therapeutic area; (b) demonstrating that acquired drugs targeting that neuronal substrate demonstrate efficacy in predictive animal tests; and (c) acquire drugs that have successfully demonstrated safety in Phase 1 clinical studies and target engagement of the desired neuronal substrate. We have identified and describe these processes as Repurposing and Rediscovery.
ReDiscovery - a process whereby value can be found by (a) mining published literature to identify a validated neuronal target; (b) identifying and acquiring drug(s) with appropriate mechanisms of action on the identified target; (c) acquiring drug(s) that have strong preclinical data demonstrating efficacy and safety and at least be ready to begin IND enabling studies in preparation for clinical trials; or (d) clinical studies demonstrating safety (Phase 1) and optimally efficacy (Phase 2).
Our first step to implement this strategy is having licensed the exclusive rights to what is now the ResolutionRx dronabinol development program, including patents granted and pending and proprietary confidential information via sublicense and license agreements with RespireRx.
Foundations of ResolutionRx
Development Strategy for OSA
In order to reduce risk, cost, and achieve R&D efficiencies we are repurposing and developing dronabinol for the treatment of OSA, according to Australian TGA and U.S. FDA and other foreign accepted regulatory pathways to market and sell a new drug.
Two Phase 2 clinical trials have been completed demonstrating the ability of dronabinol to significantly reduce the symptoms and quantitative measures of obstructive sleep apnea ("OSA"), a sleep related breathing disorder that afflicts an estimated 90 million people in the US, Australia, Germany, and UK combined.
Issued and pending patents claiming compositions and methods for treating sleep related breathing disorders, such as OSA and other conditions, as well as novel dosage and controlled release compositions applicable to dronabinol and other drug candidates.
Defined Regulatory Route to Commercialization
505(b)(2) NDA in US and similar filings in other countries creates expedited path to market by allowing publicly available safety data.
Business plan, financial projections and independent evaluation in place.