Friday, January 28, 2022 4:48:38 PM
From the press release:
Study design:
Study NLC-V-01 was a double blinded randomized placebo-controlled study designed to evaluate the safety and efficacy of NLC-V (Tollovir™) in adult patients with a confirmed diagnosis of SARS-CoV-2 infection, who are hospitalized due to the infection. Approximately 78 patients were set to be randomized using a 1:1 ratio (approximately 39 per arm) and stratified by weight group (<70 kg, 70-100kg, and >100kg) to receive Tollovir or placebo, in addition to standard of care. Patients who need mechanical ventilation received the randomized treatment using Liquid Syrup. The Company paused enrollment of the NLC-V-01 clinical trial after enrollment of 31 patients to perform an interim-analysis to evaluate the safety and efficacy profile of Tollovir.
(a) Part 1: Tollovir Clinical Trial Part 1 (TCTP1) (N=11): Tollovir formulation 1 (TLVR1) + SOC (N=6) vs. Placebo + SOC (N=5). This part of the study enrolled patients from December 2020 through February 2021 primarily during the Third COVID Wave (Alpha and Beta variants).
(b) Part 2: Tollovir Clinical Trial Part 2 (TCTP2) (N=20): Tollovir formulation 2 (TLVR2) + SOC (N=11) vs. Placebo + SOC (N=9). This part of the study enrolled patients from May 2021 through November 2021 primarily during the Fourth COVID Wave (Delta variant).
Part 2 Conclusion:
The data from part 2 indicates that patients exposed to Tollovir (TLVR2) + SOC showed better overall clinical improvement (as measured by the endpoints described in Table 1 above) as compared to patients who were treated with placebo + SOC.
