With a pandemic still raging and a mass vaccine initiative in motion, there;s still quite a ways to go before therapies won’t be needed. The quest to test novel coronavirus-targeted therapies continues at University Hospitals in Cleveland, Ohio. One of the first hospitals nationwide to participate in an investigational drug for outpatients COVID-19 case, this trial site within an elite health system, studies what’s called RHB-107 (Upamostat), which has purportedly “demonstrated antiviral and potential tissue-protective effects,” according to a recent press release from University Hospitals. Here at this renowned institution, clinical trials are led by the Clinical Research Center and this innovative study includes significant decentralized elements as patients administer the drug at home as well as receive study nurse visits and keep track of the process via smartphone and other devices.
TrialSite introduces the network to the trial site, the investigational product and its sponsor as well as the broader health system here in Cleveland, Ohio.
What is the study drug?
The drug originates from an intellectual property deal where the present sponsor, RedHill Biopharma, acquired worldwide exclusive development and commercialization rights for all indications from a German biotech called WILEX AG back in 2014. There was a carve out exception held back for East Asia including China, Hong Kong, Taiwan and Macao.
Under development by biotech firm RedHill Biopharma, RHB-107 (Upamostat) was formerly known as MESUPRON and is a proprietary, first-in-class orally-administered potent inhibitor of serine proteases targeting multiple indications, including COVID-19, cancer, inflammatory lung diseases and gastrointestinal diseases.
Under a Phase 2/3 clinical development program, the effort targets patients with symptomatic COVID-19 which doesn’t require inpatient care. The experimental drug has a combined antiviral and potential tissue-protective action possibly representing a formidable candidate for evaluation as a prospective treatment for SARS-CoV-2 infection, the virus behind COVID-19.
This investigational product targets human cell factors involved in preparing the spike protein for viral entry into target cells potentially minimizing the likelihood for resistance due to emerging viral variants with mutations in the spike protein reports the sponsor. But it also has demonstrated considerable inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model and previous preclinical work evidenced possible tissue-protective action.
Shows Promise in Early-Stage Cancer Studies
To date RHB-107 has undergone several Phase 1 clinical trials and two Phase 2 studies in locally advanced non-metastatic pancreatic cancer and metastatic breast cancer where it was evidenced clinical safety and tolerability profile in about 200 patients. In these studies, the experimental drug suggested activity as measured by both tumor response rate and overall survival of patients when administered in combination with first-line chemotherapeutic agents reports Redhill Biopharma.
FDA Orphan Drug Designation
Because of the results thus far in the cancer investigational field, RedHill Biopharma submitted to and received from the U.S. Food and Drug Administration (FDA) an Orphan Drug designation for the adjuvant treatment of pancreatic cancer.
The Patient-Centric at Home Study
This Phase 2/3 clinical trial (NCT04723537) targeting 310 patients is conducted at a medical facility here at University Hospitals, as well as other trial site locations such as South Florida Research Phase I-IV, Inc., Henry Ford Hospital emergency department (Detroit, MI), VA Sierra Nevada Health Care System (Reno, NV) and possibly others. It just started this month and runs till September, 2021.
Led by Dr. Grace McComsey as Principal Investigator here in Cleveland, those patients that are positive for COVID-19 but do not need hospitalization and who meet all other inclusion and exclusion criteria are randomized to the treatment and provided with medication and home monitoring devices. They are instructed in drug administration and use of the devices which makes this trial partially a patient-centric, decentralized affair.
This two part study includes part A) where patients are randomized 1:1:1 to one of two doses of the study drug or placebo. Based on the safety results of part A, a dose for part B) will be picked, and thereafter participating patients will be randomized 3:2 to active versus placebo.
Patients will self-administer the investigational medicine once a day for two weeks, as well as complete a smartphone-based questionnaire, provide additional monitoring information via other devices supplied periodically over an 8-week period.
Patients will be visited by a study nurse after the second, fourth and eight weeks of study and additional televisits are also included in the trial. During the home visits the study nurse will collect not only nasal swab specimens for COVID-19 PCR but also blood specimens for safety labs and disease markers.
Key Goal: Early Onset Treatment—Stop Disease Progression
In a recent University Hospital press release, Dr. McComsey, again the PI for this study, emphasized, “This is what we need currently; we need early COVID-19 studies to keep people at home and out of the hospital and keep COVID-19 as a mild illness that does not progress.”
The PI continued that, “The purpose of this research study is two-fold: Firstly, to ascertain the most appropriate dose and secondly, to test the safety of the drug and to see if it can help people with early COVID-19 infection. Participants will take Upamostat or placebo just once per day.”
University Hospitals Clinical Research Center
University Hospitals Cleveland Medical Center (UH Cleveland Medical Center) is a major not-for-profit medical complex in this Midwest city. Since 1986, University Hospitals has been an affiliate hospital of Case Western Reserve University. Home to world class clinical and research centers—from cancer and pediatrics to women’s health, orthopedics, spine, oncology and much more, research is conducted out of the Clinical Research Center.
The UH Clinical Research Center provides support across all aspects of clinical and translational research and offers the centralized shared services and infrastructure supporting investigators across this sprawling health system. Led by Dr. Grace McComsey, the shared research service includes a large professional staff to support myriad research endeavors.
About the Sponsor
Redhill Biopharma Ltd., public traded (NASDAQ: RDHL) is an Israeli and American-based specialty pharmaceutical company with an emphasis on gastrointestinal and infectious diseases. With a headquarter in Israel, the company’s U.S. commercial operations are based in Raleigh, North Carolina. Their existing authorized products focus on gastrointestinal and infectious diseases.
The company, founded in 2009, is developing a pipeline involving several drug candidates in various stages. Priced at this writing at 11.29, the company’s market capitalization currently stands at $469.5 million. The company loses money (about $60 million) and possesses about $34.7 million in the bank, reports Yahoo Finance.
Call to Action: If you are based in the Cleveland area and have a loved one diagnosed with COVID-19 at University Hospitals, consider this study. Follow the link to learn more or call 1-833-788-7425.