“We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing."
Leronlimab (PRO 140) demonstrated promising results in 49 patients with coronavirus disease 2019 (COVID-19) who received the CCR5 antagonist as treatment under the FDA’s emergency Investigational New Drug (eIND) program, according to a press release from CytoDyn, developer of the drug.
“We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system,” Nadar Pourhassan, PhD, president and chief executive officer of CytoDyn, states in a press release. “With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.”
While data are pending for 10 patients and 5 additional patients have been cleared to receive leronlimab under the eIND, 54 patients have been approved by the FDA for treatment under the eIND.
Eleven of the 49 patients were treated in Intensive Care Units (ICU) in New York and were treated with leronlimab due to acute respiratory failure, and 8 of these patients were placed on mechanical ventilation. One patient had poor baseline pulmonary status and was therefore not intubated.
Seven of the 11 patients had previously undergone an organ transplant, of which 6 were renal-transplant recipients and 1 had a heart transplant. All of the 7 patients were on an immunosuppressive treatment regimen. Ten patients were on dialysis, and 9 patients were on vasopressors during their time in the hospital. Investigators believe that leronlimab was able to save the lives of 4 patients with preexisting and severe conditions.
Blood samples from all patients treated in the New York hospital were evaluated and demonstrated powerful data supporting the effectiveness of leronlimab. These data have been submitted to a journal for expected publication in early May.
One patient treated in a different hospital in New York has been taken off oxygen and discharged after receiving therapy with leronlimab.
Of 23 patients treated in a Southern California hospital, 6 were in critical condition and intubated, and 17 patients were severely ill and in need of oxygen support. No deaths were reported among these patients. Of the 6 intubated patients, 3 were extubated, 2 were relatively stable and still breathing with assistance of a ventilator, and 1 patient had deterioration in respiratory parameters.
Among the 17 severely ill patients, 11 patients had improvement in respiratory parameters, including 8 who were discharged from the hospital; 2 patients remained relatively stable; 2 patients had deterioration in respiratory parameters, and 2 patients recently treated with leronlimab are pending results.
Three additional patients were treated in a Georgia hospital, where 2 of them had renal failure at the start of treatment, and 2 patients were extubated. One patient remains intubated but has shown improvement.
One patient treated in a Northern California hospital is being weaned off the ventilator for transfer to a rehabilitation hospital.
“We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days,” said Bruce Patterson, MD, chief executive officer and founder of IncellDx, a diagnostics company and advisor to CytoDyn, in a statement.
The randomized phase II clinical trial of leronlimab as treatment of patients with mild-to-moderate COVID-19 and the randomized phase IIb/III trial of leronlimab for severe and critically ill patients with COVID-19 are currently enrolling in the United States. The agent will be administered to patients for 2 weeks, and the primary end point is the mortality rate at 14 days. An interim analysis is expected to be conducted on the first 50 patients treated with leronlimab on the study.
Leronlimab has been explored as a potential therapeutic option for patients with cancer. CCR5 plays a potential role in the tumor invasion, metastases, and control of the tumor microenvironment. Increased CCR5 expression can indicate disease status among several cancers, according to published data supporting the antagonist’s potential in reducing tumor metastases in aggressive forms of breast and prostate cancers.
Leronlimab received a Fast Track designation from the FDA in May 2019 as treatment in combination with carboplatin for patients with CCR5-positive metastatic triple-negative breast cancer. In March 2020, the FDA recommended a preliminary meeting to determine leronlimab for a potential Breakthrough Therapy designation based on findings from a phase Ib/II clinical trial.
CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries [news release] Vancouver, WA: CytoDyn; April 30, 2020. https://bit.ly/2zFL8lS. Accessed April 30, 2020.