Novant Health will be one of the first clinical investigational sites to study whether a medication called leronlimab could be used to treat SARS-CoV-2, the virus behind the COVID-19 pandemic. Previously, leronlimab has been used in combination with medications to treat HIV and metastatic triple negative cancer. Novant Health, an integrated network of physician clinics, outpatient facilities and hospitals delivering seamless and convenient healthcare experiences to the Southeast, accomplished site initiation—a process that typically takes months—in just four days, shattering records. Consequently, they were the first site in the southeast U.S. and second site in the country to initiate the trial.
Site Activation & Initiation: Shattering Records
Typically, clinical trial site initiation can take months and depending on the site organization (whether it is a large academic medical center, major health system or small-focused investigational site organization) expedience can vary. But with the advent of the COVID-19 pandemic, TrialSite News has observed site initiation and study startup record after record shattered as research operation administration (including legal and compliance) understand the urgency and severity of current conditions in the middle of a pandemic. Novant Health, a major provider in the southeast, is no exception. With 15 hospitals, over 674 outpatient locations, 30+ imaging centers and over 605 physician clinics the integrated physician network isn’t small yet has moved as agile as a startup in today’s environment. Under normal conditions Novant Health’s clinical research team focuses on activating clinical trials in oncology, heart and vascular, neurosciences, orthopedics, pediatrics and other areas. With the pandemic they executed an unprecedented pivot—like many other providers—to support COVID-19 trial activation.
The Study Drug: Leronlimab
An investigational drug to treat HIV infection, it belongs to a group of HIV drugs called CCR5 antagonists. Sponsor CytoDyn’s lead product candidate they position as part of a wave of new class of antiviral agents for HIV. As described via the CytoDyn website, the investigational drug protects healthy cells from viral infection. They note that the current standard of care for HIV, HAART, waits for the virus to enter the cell and commences replication, prior to attacking the virus. The company posits that leronlimab, the “world’s first injectable, subcutaneous injection for HIV,” has potential advantages against HAART including no serious side effects or serious adverse events as evidenced thus far with exposure to over 800 patients. Moreover, the company touts the recent completion of a Phase III clinical trial where leronlimab was used in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients—the sponsor reports the study met its endpoint.
Consequently, the U.S. Food and Drug Administration has awarded Fast Track Designation for the investigational therapy and CytoDyn submitted the first section (non-clinical) of its Biological License Application (BLA) for the indication studied; the sponsor’s team is working on the remaining portions of the BLA (e.g. clinical, CMC).
Novant Health is collaborating with biotech sponsor CytoDyn, Inc, the maker of leronlimab, on two Phase II clinical trials including 1) a study targeting 75 patients with mild-to-moderate symptoms of respiratory illness caused by SARS-CoV-2 infection and 2) another study addressing subjects with severe or critical cases of the novel coronavirus. This latter study will involve 390 patients.
For the first study, a two-arm, randomized, double-bind, placebo controlled multicenter study, evaluates the safety and efficacy of leronlimab (PRO 140) in this patient base. The study started April 1, 2020 and runs through April 2021. The study drug arm will receive 700 mg of leronlimab (PRO 140). While in the second study, again addressing severe-to-critical COVID-19 infections, the study commenced April 15, 2020 with a target primary completion date as the end of the year.
The final study completion date is forecast for April 1, 2021. In this second Phase 2b/3, two-arm, randomized, double-blind, placebo-controlled, adaptive design multicenter study, Novant Health joins other research centers to evaluate the safety and efficacy of leronlimab (PRO 140) in again patients with severe or critical symptoms and will receive weekly doses of 700 mg leronlimab of placebo. The drug will be administered via subcutaneous injection.
Novant Health is an integrated network of physician clinics, outpatient facilities and hospitals that delivers seamless and convenient healthcare services to communities in Virginia, North and South Carolina, and Georgia. This network consists of more than 1,600 physicians and over 29,000 employees that provide care at nearly 700 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics. In 2020, Novant Health was the only healthcare system in North Carolina to be included on Forbes’ Best Employers for Diversity List. Diversity MBA Magazine has also ranked Novant Health third on its 2019 list of “Best Places for Women & Diverse Managers to Work.” The system has provided more than $993.2 million in community benefit, including financial assistance and services. The provider touts its ability to bring together world-class technology and clinicians to provide quality care.
Novant Health Clinical Research
The provider’s clinical research division places an importance on the clinical research as a care option movement. As clinical trials are part of medical research, they are in fact at the heart of all medical advances—hence the importance of using them as a means to prevent, detect and/or treat diseases. The clinical research team has access to a significant provider network in the southeast United States.
Based in Vancouver, Washington, this late-stage biotech company seeks to advanced targeted therapies addressing cancer, HIV and other autoimmune diseases, with the goal of improving the quality of life for patients while simplifying treatment plans.
Publicly traded under the symbol “CYDY,” the company trades as of this writing at $2.92 per share for a market capitalization of $1.48 billion. With a forecasted lost of $58 million, the company holds just several million cash in bank. Their stock did rise with recent news of its HIV drug. See their most recent investor presentation. An important purported differentiator is their leronlimab, monoclonal antibody CCR5 receptor antagonist—used as a platform drug for a variety of indications including now COVID-19. The company gained some recognition when actor Charlie Sheen expressed interest in their HIV drug. However like many small publicly-held biotech companies they are dependent on continuous infusions from ongoing investment by the public. The stock would be considered high risk.
The same Novant Health’s Clinical Research team and principal investigator are serving both studies.
Michael Morgan, MD, Principal Investigator
Call to Action: If you reside near a Novant Health facility in the southeast and have a family member that is sick with COVID-19, consider these studies if your physician thinks they may be relevant. Contacts include Kathleen O’Brien 704-996-7627 and Pailing Richards, 704-996-7627.