Baylor University Medical Center prepares to initiate a clinical trial investigating leronlimab, an investigational drug for HIV infections that has been under clinical evaluation due to its apparent ability to inhibit lung inflammation associated with COVID-19. With the goal to reduce breathing problems and help patients with severe to critical COVID-19 cases, the prominent Texas academic medical center (and largest not-for-profit health system in Texas) was selected by drug sponsor CytoDyn to participate in an ongoing Phase 3 clinical trial. Northern Texas research sites get busy as well in the fight against COVID-19.
What is Leronlimab?
As reported in TrialSite, Leronlimab, a humanized IgG4 monoclonal antibody (mAb) that blocks CCR5 (a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH), acts as a viral-entry inhibitor. The drug actually masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. The U.S. Food and Drug Administration (FDA) has granted CytoDyn Fast Track designation for the use of leronlimab as a combination therapy with HAART for HIV-infected patients for metastatic triple-negative breast cancer. The drug is now being investigated to determine if it can reduce breathing problems associated with COVID-19.
Study Results Thus Far for COVID-19
Recently, the sponsor was satisfied with Phase 2 results in a press release, highlighting that in the interventional arm had less serious adverse events than the placebo. The company will announce efficacy results as soon as statistical analyses are completed. CEO Dr. Nader Pourhassan reports, “We have over 1,100 patients’ safety data that shows that we have hardly any serious adverse events.”
This is the second Phase 2 clinical trial CytoDyn has commenced the other targeting a broader COVID-19 patient population while this study involves severe to critical patient cases. The Phase 2b/3, two-arm randomized, double-blind, placebo controlled, adaptive design multicenter study evaluates the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by COVID-19. Patients in this study will be randomized to receive weekly doses of 700 mg leronlimab in patients with severe or critical respiratory illness caused by SARS-CoV-2 infection. Patients are randomized to receive the weekly doses of 700 mg leronlimab, or placebo. Both the interventional drug and the placebo will be administered via subcutaneous injection. The study includes three phases including 1) Screening Period 2) Treatment Period and 3) Follow-up Period.
The study started in April and runs through December 2020 with the final estimated completion date of April 1, 2021. A multicenter study with sites in 9 states including two in Texas: Baylor University Medical Center and University of Texas. The sponsor lists the sites here. At the Baylor site, the leronlimab study is led by Principal Investigator Uriel Sandkovsky.
Baylor University Medical Center
Baylor University Medical Center, part of Baylor Scott & White Health, is a not-for-profit hospital in Dallas, Texas. With 1,025 licensed beds, it is considered a major center for patient care, medical training and research in North Texas. The Baylor Scott & White Research Institute (BSWRI) is the dedicated research and development arm of the largest not-for-profit healthcare system in Texas. BSWRI offers the critical infrastructure and operational resources necessary to conduct clinical trials safely and effectively across a broad range of specialty areas, such as cancer and heart and vascular. Clinical trials such as the leronlimab initiative actually occur at bespoke BSWRI research centers, as well as through programs led by research teams at hospitals and clinics throughout the health care system.
Impressive Research Operation
BSWRI lists all clinical trials and overall runs a world class research operation with over 600 employees, including scientists, laboratory assistants, research nurses, clinical research assistants and research coordinators. BSWRI utilizes more than 200,000 square feet of research space and conducts over 2,000 active research protocols, spanning more than 60 medical specialties. This North Texas Health System services over 800,000 patients, and with state-of-the-art medical records technology, the BSWRI can more efficiently and effectively match potential study to patient with the potential need. BSWRI has an impressive research publication record showing up in over 500 peer reviewed publications.
Research Full Throttle in North Texas
As reported recently by NBC 5 Dallas-Fort Worth, North Texas is activated to contribute to the war on COVID-19. Television health journalist Bianca Castro reports that leronlimab is just one of 450 therapeutic candidates under study, according to Market Report. With twenty-six vaccines now in clinical trials, a number of North Texas sites will participate in Phase 3 vaccine trials. Meanwhile, clinical investigational sites such as Benchmark Research have also been chosen for some of these vaccine trials.
TrialSite News introduced the COVID-19 Protection Network, which represents the merging of four other National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) trial site networks, centering on infectious disease such as HIV/AIDs, into one seamlessly integrated mega-site network with its own website to streamline the volunteer recruitment process nationwide. Dr. Anthony Fauci, director of NIAID and a seasoned research veteran, is the architect behind the nation’s research response to COVID-19. Patient engagement with an emphasis on diversity represents an important goal of the COVID-19 Protection Network. Stephaun Wallace, director of external relations for the COVID-19 Prevention Network, reports, “We need diverse numbers of folks to participate, ethnic, racial groups, occupational groups, ages.” This can be a challenge as different populations have different or overlapping concerns about clinical research. For example, there are known challenges in African American patient recruitment, which have been ongoing for many years. See TrialSite’s African American Clinical Research Disparity Survey.
Uriel Sandkovsky, MD, Infectious Disease
Call to Action: Does all this clinical research seem overwhelming? Well that’s because there is a lot going on. If you are based in North Texas and interested in a breakdown of available vaccine and other COVID-19 research, feel free to contact TrialSite.