LIPIDRESCUE®
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Note: LipidRescue® is an investigational drug; the safety and efficacy of the drug have not been approved or authorized by FDA. LipidRescue® is a proposed proprietary name that is subject to FDA approval.
Physiology Predicts Purpose
LipidRescue® Therapy can exert several physiological effects that contribute to potential medical indications for which it might be used. These effects include binding lipid soluble drugs, increasing cardiac contractility and protecting heart cells from the injury that occurs after recovery from periods of poor coronary blood flow, ischemia-reperfusion injury (IRI). The potential clinical benefits of such effects include the rapid reversal of drug toxicity and improvement in heart function after acute, ischemic stress.
Toxicity Indications
LipidRescue® is currently used to local anesthetic systemic toxicity (LAST) and has been used in a variety of other, prescription and non-prescription, non-opiate drug overdoses (NODO), including those related to methamphetamine, cocaine, tricyclic antidepressants, anti-psychotics, beta-channel blockers and calcium-channel blockers.
Cardiac Indications
LipidRescue® is shown in a variety of models (e.g., intact animal, isolated organ, cell culture) to reduce IRI and therefore could, theoretically, improve cardiac function whenever blood flow has been restored to a heart where it had been interrupted. The adverse effects of IRI are seen very commonly after successful resuscitation from cardiac arrest as these patients often succumb a day or so later when the IRI severely impairs cardiac function. This is an example among many (e.g., after heart surgery, including heart transplant) where LipidRescue® Therapy can potentially benefit patients with acute, life-threatening heart failure.
Evidence in Toxicity and Cardic Injury
Toxicity: Data from diverse animal and computer models, along with published clinical case reports and volunteer studies support the benefit of LipidRescue® Therapy to reverse LAST. Case reports may also support its potential value in toxicity caused by overdose of other lipid soluble drugs. In the clinical setting, LipidRescue® Therapy has been reported to rapidly reverse signs of both cardiovascular and central nervous system (CNS) toxicity.
Cardiac: Data from a variety of animal and cell models and in several different laboratories suggest that LipidRescue® Therapy can also improve cardiac function after an ischemic challenge where IRI has reduced cardiac function.
Mechanisms
LipidRescue® Therapy can reverse LAST by a combination of three key effects: a pharmacokinetic benefit (accelerated redistribution); direct improvement of cardiac contractility; and reduction of IRI.
The improved cardiac contractility and reduction of IRI may result from activation of both an insulin-like signaling pathway and a potent, cell-protecting pathway, respectively.
Regulatory Status
Infusing a lipid emuilsion for LAST has received approval for orphan drug designation by the FDA. ResQ Pharma held a preNDA meeting with FDA in December 2020 and filed an NDA for the LAST indication in December, 2022.
Potential for Helping Patients
Combining its use in LAST, non-opiate drug overdoses (NODO) and various cardiac indications, LipidRescue® has the potential to benefit many critically ill patients.