University of California Irvine, (UCI) recently announced their participation in a COVID-19-focused clinical trial investigating a drug called Aviptadil in at risk patients. Dr. Richard Lee, Interim chief of UCK Health Division of Pulmonary Diseases and Critical Care Medicine, as well as principal investigator for the clinical trial, commented that “This study will focus on patients for whom mortality is alarmingly high.” What is the drug? Who is the study’s sponsor? What is the nature of the COVID-19 study?
TrialSite News sought to evaluate this study and actually uncovered two studies the sponsor is leading that investigate the use of Aviptadil.
What is Aviptadil?
According to the National Institutes of Health (NIH), Aviptadil is an injectable formulation of vasoactive intestinal polypeptide (VIP) in combination with adrenergic drug phentolamine. Interestingly, the initial focus was alternatives to erectile dysfunction (combining Aviptadil with phentolamine and sexual stimulation) as the combination was free of major side effects and cumbersome delivery methods which limit the use of other pharmacologic preparations.
What is a vasoactive intestinal polypeptide?
Known as VIP, this is a peptide hormone that is vasoactive in the intestines. VIP is a peptide of 28 amino acid residues that belongs to a glucagon/secretin superfamily, the ligand of class II G protein-coupled receptors. VIP is produced in many tissues of vertebrates including the gut, pancreas and suprachiasmatic nuclei of the hypothalamus in the brain. It actually triggers contractility in the heart, causes vasodilation, increases glycogenolysis, lowers arterial blood pressure and relaxes the smooth muscle of the trachea. In humans, the vasoactive intestinal peptide is encoded by the VIP gene.
Who is the study’s sponsor?
NeuroRX, the study sponsor, was founded in 2015 and dedicates its effort to developing NRX-101, the first oral therapeutic for the treatment of Acute Suicidal Behavioral/Ideation (ASIB) in Bipolar Disorder. Based in Wilmington, Delaware, the biotech venture has raised approximately $25 million in three rounds including a $15 million C round. In 2019 according to a company informational they secured up to HK$750m via an intermediary called Gem Global Yield LLC SCS (Gem). According to their website, GEM acquires majority stakes in operating companies by recapitalizing balance sheets, executive management and ideally partners with the operational team to execute strategic plans for value creation. But a possible red flag there appears to be considerable financial engineering with this company.
Two studies have recently been disclosed by sponsor NeuroRX in relation to COVID-19, including the one University of Irvine recently announced. In the Phase II study, the sponsors and investigators target up to 144 patients representing those most at risk for COVID-19—the patients that fall to acute lung injury/acute respiratory distress syndrome (ARDS) that results in the death of up to 80% of those who develop ARDS, despite intensive care and mechanical ventilation. The investigators will treat those who contract SARS-CoV-2 and ARDS who are admitted in the hospital for intensive care including endotracheal intubation and mechanical ventilation with Aviptadil—the synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care versus placebo in addition to maximal intensive care. Patients will be randomized to intravenous Aviptadil and receive escalating doses from 50-150 pmo/kg/hr over 12 hours.
The study involving UCI commenced in May 2020 and runs through September 2020. Participating clinical investigational sites include UCI, Miller School of Medicine (University of Miami), Robert I Grossman School of Medicine (NYU Langone Medical Center), Thomas Jefferson University Hospital and Rambam Health Care Campus in Haifa, Israel.
What are the study’s primary outcome measures?
The study team will monitor and track mortality [5 day with follow up through 30 days] along with “Index of Respiratory Distress” or PaO2:FiO2 ration [5 days follow up through end of telemetry monitoring].
Secondary outcome measures can be viewed here.
Who are the Collaborators?
A few organizations are participating in this study, including Relief Therapeutics Holdings, SA, (Swiss-based venture focusing on clinical development of peptides and proteins); Target Health, Inc. (CRO); and Lavin Consulting, LLC (Biostatistical consulting).
Richard Lee, MD, UCI Health Division of Pulmonary Diseases and Critical Care Medicine, Principal Investigator
Call to Action: This study is for at-risk SARS-CoV-2 patients in one of the centers mentioned above. If there is a loved one hospitalized with COVID-19 in one of the centers with the inclusion criteria, this trial might be considered. Note, for those investors interested in learning more about NeuroRx, their investor relations are managed by Solebury Trout’s Chiara Russo.