Regeneron halts one phase III COVID-19 trial7 Jul 2020 07:34
Regeneron halts one phase III COVID-19 trial while starting two others
July 6, 2020
By Lee Landenberger
Missing the primary endpoint along with key secondary endpoints in a phase III trial of Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for treating COVID-19 patients who need mechanical ventilation caused Regeneron Pharmaceuticals Inc. and Sanofi SA to halt the study.
Tarrytown, N.Y.-based Regeneron then followed the closing by initiating two late-stage studies, a phase III and a phase II/III, to evaluate REGN-CoV2, a double antibody ****tail for treating and preventing COVID-19.
The stumble produced a good day for Tiziana Life Sciences plc (NASDAQ:TLSA), whose stock rose 9.6% July 6, closing at $7.19 a share. London-based Tiziana is developing its own anti-IL-6 receptor monoclonal antibody, TZLS-501, to be delivered directly into the lungs of a COVID-19 patient using an inhaler or nebulizer. In April, the company filed a patent application to support the treatment.
H.C. Wainwright and Co. analyst Raghuram Selvaraju wrote Monday morning that he believes “TZLS-501 may prove successful where Kevzara failed.” He also noted that TZLS-501 may also demonstrate superior efficacy to Actemra (tocilizumab) from Roche Holding AG, which is in late-stage development for treating coronavirus patients and is also being tested in combination with Gilead Sciences Inc.’s remdesivir.
“TZLS-501, a unique and best-in-class anti-IL-6R mAb, follows a dual mechanism by not only blocking downstream signaling pathways from membrane-bound and soluble IL-6 receptors but also rapidly depleting bloodstream (i.e., systemic) levels” of IL-6, Selvaraju added.
The study of Kevzara, a drug usually prescribed for treating rheumatoid arthritis, had problems before this halt. The study was amended in late April after an independent data monitoring committee reviewed all the available phase II and phase III data and found that, compared to placebo, the treatment “had no notable benefit on clinical outcomes” in patients with severe or critical respiratory illness caused by COVID-19. The study was tweaked immediately afterward so that only critically ill COVID-19 patients would be enrolled to receive Kevzara or placebo.
In the amended study results, there were some minor positive trends noted in the primary prespecified analysis group, which were critical patients receiving Kevzara 400 mg and were mechanically ventilated at baseline, that failed to reach statistical significance. However, negative trends in the subgroup of critical patients not mechanically ventilated at baseline countered the positive ones.
The trial’s primary analysis group included 194 patients who were critically ill with COVID-19 and receiving mechanical ventilation at the time they were enrolled. The primary endpoint was an assessment of patients achieving at least a one-point change, on a seven-point scale, from baseline. The scale included death; those hospitalized requ
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