St. Elizabeth Hospital in Edgewood, Kentucky, was selected as the first clinical investigational site for a Phase II clinical trial studying a new drug to treat COVID-19 called PUL-042, an inhalation solution under investigation to help COVID-19 from progressing in patients already infected by the pathogen. St. Elizabeth, based in Northern Kentucky, is the first hospital in the world to start dosing patients with the virus. The participating contract research organization’s (CRO) CEO reports that St. Elizabeth Hospital went first because of their speed, agility and IRB approval process as well as study drug training commitment.
The PUL-042 is developed by sponsor Pulmotect, a clinical stage inhaled therapeutic that in preclinical studies stimulates the innate immune system in minutes to provide immediate and effective protection against all major classes of pathogens that lasts for days. The sponsor received $1.3 million grant funding from the federal government back in 2013.
Sponsored by Pulmotect, St. Elizabeth Hospital leads the study effort, along with a couple other research sites. The study centers on adults who have confirmed cases of SARS-CoV-2 infection and who do not require supplemental oxygen. These patients will receive PUL-02 inhalation solution or placebo three times over a one-week period in addition to their normal care. These patients will then be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome.
The study commences in late May and runs through October 2020. Other sites (potentially up to 10) include Ascension St. John and Texas Center for Drug Development. St. Elizabeth’s principal investigator, Chai Mandapakala, MD, commented recently, “The drug PUL-042 boosts the innate immunity in the lungs and potentially prevents further lung damage when used early in the COVID-19 disease,” reported local television news Fox 19.
Study Objective: Avoid Lung Damage & Ventilators
The Sponsor and sites hope to help COVID-19 patients avoid lung damage. The PI Dr. Mandapakala reports, “If this clinical trial is successful it can help health the disease faster, decrease length of hospital stay and improve outcomes without needing to get on a ventilator, which is exciting.”
Contract Research Organization (CRO) Involvement
CRO Clinical Trial and Consulting Services (CTI) has been retained by the sponsor to help run the study. The global CRO is based in Cincinnati. The CRO’s CEO, Tim Schroeder, commented, “The COVID-19 pandemic demands an unprecedented response from the pharmaceutical and biotechnology communities, requiring innovation, collaboration and prioritization of speed without the cost of safety.”
The Site: St Elizabeth Health
Of note, CEO of CTCS Tim Schroeder commented on attractiveness of working with St. Elizabeth Hospital, “They are the first site to begin screening on this trial because of their ability to quickly executive contracts, develop a site budget, receive IRB approval, and be trained faster than any other site in the U.S.” TrialSite News comments that this is a powerful testimony to the clinical research team at St. Elizabeth Hospital. Note that St. Elizabeth Clinical Care Clinical Research has won awards in 2017 and 2018 via the National Clinical Trial Network High Performing Site Award from the National Cancer Institute for having both a high number of patients enrolled in cancer clinical trials and high-level quality data.
St. Elizabeth Hospital (Healthcare) is one of the most respected medical providers in the Greater Cincinnati region. They have been in operation for over 150 years.
Based in Texas, Pulmotect was founded in 2008 and has raised $11.8 million in two financing rounds. They focus on the development of products (host-directed/pathogen-agnostic) to reduce morbidity and mortality in patients at risk of severe respiratory diseases. Their technology stimulates the body’s natural defenses to provide safe, broad-spectrum, fast-acting protection against bacterial pneumonia (including MRSA), influenza, fungal pneumonia, and Class A bioterror agents (including anthrax, tularemia and plague).
CEO Colin Broom has considerable experience serving in leadership positions across multiple therapeutic areas from oncology and anti-infectives to pulmonary medicine. He served as CEO of Nabriva Therapeutics Plc and served as Chief Scientific Officer at ViroPharma Inc. until its acquisition by Shire in 2014 and several other prominent large companies such as Amgen and others.
Lead Research/Investigator at St. Elizabeth Hospital
Call to Action: If you have a loved one diagnosed with COVID-19 and at St. Elizabeth Hospital, consider this study. Clinical sponsors—think about St. Elizabeth Hospital for future studies. Finally, investors should learn more about Pulmotect.