Vyrologix Leronlimab (Pro 140) Description
Vyrologix™ Leronlimab (PRO 140) is a drug candidate that is a CCR5 antagonist with the potential for multiple therapeutic indications. Leronlimab belongs to a group of HIV drugs called CCR5 antagonists.
Produced by CytoDyn, Vyrologix Leronlimab (Pro 140) is a humanized monoclonal antibody targeted against the CCR5 receptor found on T lymphocytes of the human immune system. It is being investigated as a potential therapy in the treatment of HIV infection.
The United States FDA has designated Leronlimab (Pro 140) for fast-track approval.
CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S., and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.
On July 21, 2020, the Phase 2 study announced 34% (19 of 56 patients) treated with leronlimab compared to 50% (14 of 28 patients) treated with placebo reported at least one adverse event. A total of 19 serious adverse events (SAEs) were reported during the study.
Eleven SAEs were reported in 6 patients (6/28; 21.4%) receiving placebo compared to eight (8) SAEs in 5 patients (5/56; 8.9%) receiving leronlimab. None of the SAEs in the leronlimab arm were deemed related to study drug administration by the investigators. Of the 84 patients treated, one patient died 33 days after enrollment due to an event unrelated to leronlimab.
On December 23, 2020, Nader Pourhassan, Ph.D., CEO of CytoDyn, commented, “We are very thankful to the FDA for guiding accessing our drug pending the results of CD12, especially during these unprecedented times. CytoDyn will provide the precise requirements for potential participation in the new CD12 open-label extension and physicians seeking eINDs, while we eagerly await the unblinding of the data. The results of our CD10 trial will not support an eIND request.”
Washington based CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.
Vyrologix Leronlimab (Pro 140) Indication
Vyrologix Leronlimab (Pro 140) is in early clinical trials to treat COVID-19 disease. Leronlimab is intended to serve as a therapy for patients who experience respiratory illness due to contracting the Coronavirus Disease 2019 (COVID-19). These patients' treatment was not under the Company’s proposed randomized controlled Phase 2 clinical trial protocol recently submitted to the FDA.
The “cytokine storm” is believed to play an integral role in developing acute respiratory distress syndrome (ARDS) in those affected by COVID-19. Chemokines and chemokine receptors play a critical role in the recruitment, activation, and coordination of leukocytes in lung inflammation's pathophysiology. The acute respiratory distress syndrome (ARDS) of COVID-19 results from the accumulation of neutrophils within the pulmonary circulation and alveolar spaces.
COVID-19 is caused by a coronavirus called SARS-CoV-2. Coronaviruses are a large family of viruses that are common in people and many different species of animals, including camels, cattle, cats, and bats. Rarely, animal coronaviruses can infect people and then spread between people.
However, this occurred with MERS-CoV and SARS-CoV, and now with the virus that causes COVID-19. The SARS-CoV-2 virus is a betacoronavirus, like MERS-CoV and SARS-CoV.
Research may prove that leronlimab is a safe and effective option for treating people with R5-tropic virus (a strain of HIV), including those for whom other entry and fusion inhibitors, such as maraviroc (brand name: Selzentry), are not working.
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans.
The Vyrologix leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
Vyrologix Leronlimab (Pro 140) News
December 24, 2020 - CytoDyn Inc. announced the U.S. FDA guided the Company through adding an open-label extension to its Phase 3 trial (“CD12”) and specific criteria for the continuation of for patients meeting the inclusion/exclusion criteria of CD12. Upon clearance, each CD12 participating clinical trial site will have the option of enrolling additional qualified patients, with all patients receiving leronlimab. Treatment of qualified patients will continue until the trial’s data is unblinded.
December 15, 2020 - CytoDyn Inc. announced it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results announced shortly thereafter.
November 23, 2020 - CytoDyn Inc., a biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it had reached an enrollment of 293 patients in its Phase 3 trial for COVID-19 patients with severe-to-critical symptoms, thereby meeting the requested criteria for a second interim efficacy analysis by the Data Safety Monitoring Committee.
November 17, 2020 - Washington based CytoDyn Inc. announced it had filed a protocol with the U.S. FDA for a Phase 2 clinical trial for leronlimab to treat COVID-19 patients suffering from long-hauler symptoms.
October 26, 2020 - CytoDyn Inc. announced the Medicines & Healthcare product Regulatory Agency of the U.K. government had cleared CytoDyn to file its Biologics License Application (BLA) leronlimab as a combination therapy for multi-drug resistance HIV patients in the UK.
October 20, 2020 - CytoDyn Inc. announced recommendations from the Data Safety Monitoring Committee following its review of the interim analysis of the Company’s Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients.
September 22, 2020 - CytoDyn’s Phase 2 Study of Leronlimab for Mild-to-Moderate COVID-19 Selected for Oral Presentation at the Special isirv-AVG Virtual Conference on ‘Therapeutics for COVID-19.’
July 21, 2020 - CytoDyn Inc. announced the results of the patient safety data from the Company’s over-enrolled COVID-19 disease Phase 2 trial for treating mild-to-moderate indications. Just 5 patients out of 56 (about 9%) reported serious adverse events; none were related to leronlimab.
May 19, 2020 - CytoDyn Inc. announced it would be coordinating with the NIH of Mexico and providing leronlimab for a trial for the severe - critical COVID-19 disease population in Mexico with the potential to collaborate on further CytoDyn COVID-19 trials. “The NIH of Mexico is committed to helping alleviate human suffering and mortality of Mexican citizens. The Metropolitan Area of the Valley of Mexico has a population of approximately 21.5 million people, and the contagious nature of COVID-19 is relentless," said Nader Pourhassan, Ph.D., President, and Chief Executive Officer of CytoDyn.
May 05, 2020 - CytoDyn Inc. announced a pre-print version of the manuscript had been made publicly available on posting with Research Square and MedRxiv describing the immunological mechanism by which leronlimab restores immune function and impacts disease in COVID-19 patients. As described in the pre-print, in a cohort of ten critically ill patients, after treatment with leronlimab, these critically ill patients experienced reversed hyperimmune activation and inflammation. They reversed immunosuppression, thereby facilitating a more effective immune response correlated with decreases in SARS-CoV-2 level in blood.
May 4, 2020 - CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible for Participation in Two Ongoing Clinical Trials in the U.S. – CytoDyn Targets Enrollment Completion for its 75 Patient, Phase 2 Trial by the end of May.
April 7, 2020 - Novant Health is initiating patient enrollment in CytoDyn’s Phase 2 randomized clinical trial for COVID-19 patients with mild-to-moderate infections. Novant Health is the first site in the southeastern United States to initiate this Phase 2 trial. And a Phase 2b/3 trial will for severe and critically ill COVID-19 patients.
March 19, 2020 - CytoDyn Inc. announced today that two coronavirus patients were treated with the Company’s investigational new drug, leronlimab. The treatment was administered at a leading medical center in the New York City area under an emergency Investigational New Drug (IND) recently granted by the U.S. Food and Drug Administration (FDA).
Vyrologix Leronlimab (Pro 140) Clinical Trials
Clinical Trial NCT04343651: Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19. Last Update Posted: August 20, 2020.
- This is a Phase 2, two-arm, randomized, double-blind, placebo-controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
- Estimated Study Completion Date: August 31, 2020.
Clinical Trial NCT04347239: Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19). Last Update Posted: November 16, 2020.
- This is a Phase 2b/3, two-arm, randomized, double-blind, placebo-controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140) or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
- Estimated Study Completion Date: April 1, 2021