VBL Therapeutics announced the dosing of the first patient in a randomized controlled Phase 2 study of the Company’s proprietary investigational oral immune-modulator molecule, VB-201 for the treatment of COVID-19. The study will assess the ability of VB-201 to prevent clinical deterioration and reduce morbidity and mortality in patients with severe COVID-19.

"While vaccines offer a major development in this pandemic, there is still a crucial unmet global need for new treatments for severe COVID patients," said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. "Manufacturing and cold-chain logistics limit access to vaccines in many regions in the world and at the same time, new and aggressive viral mutations are being identified. There is an understanding that the therapeutic arsenal against COVID must be enriched, both to combat the current pandemic as well as for future viral outbreaks. We believe that, as a safe and affordable oral therapy, VB-201 has the potential to bridge this gap by limiting the life-threatening hyper-inflammation in this deadly disease.”

VB-201 is designed to offer differentiation from other immune modulators evaluated as treatments for COVID, and its anti-inflammatory activity in the cardiovascular system may benefit patients with COVID-related Kawasaki-like multisystem inflammatory syndrome. Studied in over 600 subjects, VB-201 previously demonstrated proof of concept in a Phase 2 study in vascular inflammation, meeting the primary endpoint of the trial.

"Treating the immune system of COVID-19 patients requires a delicate balance between preventing cytokine storm and suppressing the body's ability to fight the virus," said Tami Rachmilewitz, M.D., Vice President Clinical Development of VBL Therapeutics. "As macrophages play a key role in the cytokine storm seen with COVID-19, targeting their accumulation in the lungs represents an encouraging strategy for curbing hyper-inflammation and tissue damage. That is exactly what we are aiming to achieve with VB-201 in this study."

VBL Therapeutics has developed the Lecinoxoids, a novel class of investigational orally-available anti-inflammatory small molecules. Lecinoxoids mimic the structure of native phospholipid molecules that regulate the inflammatory process. By modulating innate immunity, the controller of the immune system, Lecinoxoids can potentially target a spectrum of immune-inflammatory diseases including cardiovascular diseases, NASH/liver fibrosis, renal fibrosis and others. Lead candidate VB-201 is an oral small molecule that has been administered to more than 600 patients, across eight clinical trials. VB-201 works via inhibition of monocyte migration as well as inhibition of the pro-inflammatory CD14/TLR4 and TLR2 pathways.