RespireRx Pharmaceuticals Inc. are pleased to announce that on October 9, 2023, ResolutionRx entered into a Master Services Agreement (“MSA”) with Ab Initio Pharma Pty Ltd.
Glen Rock, N.J., Oct. 12, 2023 (GLOBE NEWSWIRE) -- RespireRx (Formerly Known As Cortex Pharmaceuticals, Inc.) Pharmaceuticals Inc. (OTC Pink Market: RSPI) (“RespireRx” or the “Company”), focused on the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, and ResolutionRx Ltd (“ResolutionRx”), an unlisted public Australian company, (Australian Company Number or ACN: 664 925 651) and a subsidiary of RespireRx, are pleased to announce that on October 9, 2023, ResolutionRx entered into a Master Services Agreement (“MSA”) with Ab Initio Pharma Pty Ltd, (“Ab Initio”) an Australian company under which Ab Initio will manufacture, formulate, test and supply ResolutionRx with therapeutic drugs based on lipid nanoparticle technology licensed from RespireRx.
The initial services relate to ResolutionRx’s repurposing of dronabinol and its development program for obstructive sleep apnea pursuant to which Ab Initio will, among other things, manufacture and test our 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 unless ResolutionRx provides written notice to Ab Initio of its intent not to renew at least ninety days prior to the end of the initial term or any renewal term.
“The importance of this partnership cannot be overstated,” said Arnold Lippa, Ph.D., co-CEO and CSO of ResolutionRx and CEO and CSO 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.”
AboutRespireRxGroup
RespireRx Pharmaceuticals Inc. and its subsidiaries and business units (“RespireRx Group”) are 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 obstructive sleep apnea (“OSA”), attention deficit hyperactivity disorder (“ADHD”), epilepsy, pain, recovery from spinal cord injury (“SCI”), and certain neurological orphan diseases . The RespireRx Group is developing a pipeline of new and repurposed drug products based on our broad patent portfolios for two drug platforms: (i) pharmaceutical cannabinoids, which include dronabinol, a synthetic form of ∆9-tetrahydrocannabinol (“Δ9- THC”) that acts upon the nervous system’s endogenous cannabinoid receptors and (ii) neuromodulators, which include AMPAkines and GABAkines, proprietary chemical entities that positively modulate (positive allosteric modulators or “PAMs”) AMPA-type glutamate receptors and GABAA receptors, respectively.
The RespireRx Group holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
ResolutionRx:PharmaceuticalCannabinoids.
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. 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 (“R&D”) 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 (“OSA”). The current total budget for that program over the next several years is approximately US$16.5 million, most, but not all of which is expected to be eligible for the Australian R&D Tax Incentive (“RDTI”). Dronabinol, an endocannabinoid receptor agonist, 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 90 million people in the United States, Australia, Germany and the United Kingdom 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 FDA approved for the treatment of AIDS related anorexia and chemotherapy induced nausea and vomiting, RespireRx and ResolutionRx further believe that its repurposing strategy would only require, in the United States, approval by the FDA of a 505(b)(2) new drug application (“NDA”), an efficient regulatory pathway that allows the use of publicly available data.
EndeavourRx:Neuromodulators
GABAkines.Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. (“UWMRF”) and on behalf of its EndeavourRx business unit, RespireRx has licensed rights to certain selectively acting GABAkines because of their ability to selectively amplify inhibitory neurotransmission at a highly specific, subset of GABAA receptors, thus producing a unique efficacy profile with reduced side effects. Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce sedation, motor-impairment, tolerance, dependence and abuse. EndeavourRx currently is focusing on developing KRM-II-81 for the treatment of epilepsy and pain.
KRM-II-81 has displayed a high degree of anti-convulsant activity in a broad range of preclinical studies, including in treatment resistant and pharmaco-resistant models. Not only was KRM-II-81 highly effective in these models, but pharmaco-resistance or tolerance did not develop to its anti-convulsant properties. These latter results are particularly important because pharmaco-resistance occurs when medications that once controlled seizures lose efficacy as a result of chronic use and it is a principal reason some epileptic patients require brain surgery to control their seizures. In support of its potential clinical efficacy, translational studies have demonstrated the ability of KRM-II-81 to dramatically reduce epileptiform electrical activity when administered in situ to brain slices excised from treatment-resistant epileptic patients undergoing surgery.
In addition, KRM-II-81 has displayed a high degree of analgesic activity in a broad range of preclinical studies. In intact animal models of pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic.
AMPAkines.Through an extensive translational research effort from the cellular level through Phase 2 clinical trials, RespireRx has developed a family of novel, low impact AMPAkines, including CX717, CX1739 and CX1942 that may have clinical application in the treatment of CNS-driven neurobehavioral and cognitive disorders, spinal cord injury, neurological diseases, and certain orphan indications. Our lead clinical compounds, CX717 and CX1739, have successfully completed multiple Phase 1 safety trials. Both compounds have also completed Phase 2 proof of concept trials demonstrating target engagement, by antagonizing the ability of opioids to induce respiratory depression.
AMPAkines have demonstrated positive activity in animal models of ADHD, results that have been extended translationally into statistically significant improvement of symptoms observed in a Phase 2 human clinical trial of CX717 in adult patients with ADHD. Statistically significant therapeutic effects were observed within one week. We believe AMPAkines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative non- stimulants, such as Straterra® (atomoxetine), and without the drawbacks of amphetamine-type stimulants.
In a series of important studies funded by grants from the National Institutes of Health and published in a number of peer reviewed articles, Dr. David Fuller (University of Florida), a long-time RespireRx collaborator, has demonstrated the ability of CX1739 and CX717, RespireRx’s lead AMPAkines, to improve motor nerve activity and muscle function in a number of animal models of spinal cord injury (SCI).
Additional information about RespireRx and the matters discussed herein can be obtained on the RespireRx web- site at www.RespireRx.com or RespireRx’s filings with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov. Additional information about ResolutionRx and the matters discussed herein can be obtained on the ResolutionRx website at https://www.resolutionrx.com.au.
NotaSecurities Offeringor Solicitation
This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shalltherebeanysalesofsecuritiesinanyjurisdictioninwhichsuchoffer,solicitationorsaleofsecuritieswould be unlawful before registration or qualification under the laws of such jurisdiction.
CautionaryNoteRegardingForward-LookingStatements
Thispressreleasecontainscertainforward-lookingstatementswithinthemeaningofSection27AoftheSecurities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended(the“ExchangeAct”),andtheCompanyintendsthatsuchforward-lookingstatementsbesubjecttothe safe harbor created thereby. These might include statements regarding the Company’s future plans, targets, estimates,assumptions,financialposition,businessstrategyandotherplansandobjectivesforfutureoperations, andassumptionsandpredictionsaboutresearchanddevelopmentefforts,including,butnotlimitedto,preclinical andclinicalresearchdesign,execution,timing,costsandresults,futureproductdemand,supply,manufacturing, costs, marketing and pricing factors.
Insomecases,forward-lookingstatementsmaybeidentifiedbywordsincluding“assumes,”“could,”“ongoing,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” “anticipates,” “believes,” “intends,” “estimates,”“expects,”“plans,”“contemplates,”“targets,”“continues,”“budgets,”“may,”orthenegativeof these terms or other comparable terminology, although not all forward-looking statements contain these words, and such statements may include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Company’s product candidates, (iv) reorganization plans, and (v) the need for, and availability of, additional financing. Forward-lookingstatementsarebasedoninformationavailableatthetimethestatementsaremadeandinvolve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performanceorachievementstobemateriallydifferentfromtheinformationexpressedorimpliedbytheforward- looking statements in this press release.
Thesefactorsincludebutarenotlimitedto,regulatorypoliciesorchangesthereto,availablecash,researchand development results, issuance of patents, competition from other similar businesses, interest of third parties in collaborations with us, and market and general economic factors, and other risk factors disclosed in “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on April 17, 2023 (the “2022 Form 10-K”).
You should read these risk factors and the other cautionary statements made in the Company’s filings as being applicabletoallrelatedforward-lookingstatementswherevertheyappearinthispressrelease.Wecannotassure you thatthe forward-lookingstatements in this press release willprove to beaccurateand thereforeprospective investors,aswellaspotentialcollaboratorsandotherpotentialstakeholders,areencouragednottoplaceundue relianceonforward-lookingstatements.Youshouldreadthispressreleasecompletely.Otherthanasrequiredby law,weundertakenoobligationtoupdateorrevisetheseforward-lookingstatements,eventhoughoursituation may change in the future.
We caution investors, as well as potential collaborators and other potential stakeholders, not to place undue reliance on any forward-looking statement that speaks only as of the date made and to recognize that forward- looking statements are predictions of future results, which may not occur as anticipated. Actual results could differ materially from those anticipated in the forward-looking statementsand from historical results, due to the risksanduncertaintiesdescribedinthe2022Form10-K,inourquarterlyreportsonForm10-Qandinthispress release,aswellasothersthatwemayconsiderimmaterialordonotanticipateatthistime.Theseforward-looking statementsarebasedonassumptionsregardingtheCompany’sbusinessandtechnology,whichinvolvejudgments with respect to, among other things, future scientific, economic, regulatory and competitive conditions, collaborationswiththirdparties,andfuturebusinessdecisions,allofwhicharedifficultorimpossibletopredict accurately and many of which are beyond the Company’s control. Although we believe that the expectations reflectedinourforward-lookingstatementsarereasonable,wedonotknowwhetherourexpectationswillprove correct.Ourexpectationsreflectedinourforward-lookingstatementscanbeaffectedbyinaccurateassumptions thatwemightmakeorbyknownorunknownrisksanduncertainties,includingthosedescribedinthe2022Form 10-K, in our quarterly reports on Form 10-Q and in this press release. These risks and uncertainties are not exclusive and further information concerning us and our business, including factors that potentially could materially affect our financial results or condition, may emerge from time to time.
For more information about the risks and uncertainties the Company faces, see “Item 1A. Risk Factors” in our 2022 Form 10-K. Forward-looking statements speak only as of the date they are made. The Company does not undertake and specifically declines any obligation to update any forward-looking statements or to publicly announce the results of any revisions to any statements to reflect new information or future events or developments.Weadviseinvestors,aswellaspotentialcollaboratorsandotherpotentialstakeholders,toconsult any further disclosures we may make on related subjects in our annual reports on Form 10-K and other reports that we file with or furnish to the SEC including but not limited to our most recent Form 10-Q as of June30, 2023 filed with the SEC on August 21, 2023.
Company Contacts:
Arnold Lippa
ResolutionRx Ltd.
Director and co-Chief Executive Officer
0011+1+201-906-2467
alippa@ResolutionRx.com.au
www.ResolutionRx.com.au
Jeff Margolis
RespireRx Pharmaceuticals Inc.
Senior Vice President, Chief Financial Officer, Treasurer and Secretary
Telephone: 917-834-7206
Email: jmargolis@respirerx.com
126 Valley Road, Suite C
Glen Rock, NJ 07452
www.respirerx.com
