VBL Therapeutics Treats First Patient in Phase 2 Randomized Controlled Study of VB-201 in COVID-19 Patients

Rhea-AI Summary

VBL Therapeutics (Nasdaq: VBLT) has commenced a Phase 2 study of its investigational oral immune-modulator VB-201 to treat severe COVID-19. The trial aims to evaluate VB-201's efficacy in preventing clinical deterioration and reducing complications in affected patients. VB-201 previously demonstrated promise in over 600 subjects during a Phase 2 trial targeting vascular inflammation. The study addresses the urgent global need for effective COVID-19 treatments, particularly in light of vaccine accessibility issues and evolving viral mutations.

Positive

• Initiation of Phase 2 study for VB-201 in COVID-19 treatment.
• VB-201 has previously shown proof of concept in over 600 subjects.
• Potential to address unmet medical needs in severe COVID-19 patients.

Negative

• None.

TEL AVIV, Israel, Jan. 27, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today 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."

About VB-201
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.

About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications. For additional information visit: www.vblrx.com.

Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding our programs, including VB-201, including their clinical development, such as the timing of clinical trials and expected announcement of data, therapeutic potential and clinical results, and our financial position and cash runway. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical clinical trial results may not be predictive of future trial results, that our financial resources do not last for as long as anticipated, and that we may not realize the expected benefits of our intellectual property protection. A further list and description of these risks, uncertainties and other risks can be found in our regulatory filings with the U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2019, and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACT:
Burns McClellan for VBL Therapeutics
Lee Roth (investors) / Ryo Imai (media)
lroth@burnsmc.com / rimai@burnsmc.com
+1-212-213-0006

FAQ

What is the purpose of VBLT's VB-201 trial?

The VB-201 trial aims to evaluate the drug's effectiveness in preventing clinical deterioration in severe COVID-19 patients.

When did VBL Therapeutics announce the Phase 2 study for VB-201?

VBL Therapeutics announced the Phase 2 study on January 27, 2021.

How many subjects were studied in previous VB-201 trials?

VB-201 has been studied in over 600 subjects across multiple clinical trials.

What are the expected outcomes of the VB-201 study?

The study is expected to demonstrate VB-201's ability to prevent severe COVID-19 complications and reduce morbidity and mortality.

What differentiates VB-201 from other COVID-19 treatments?

VB-201 is designed as an oral therapy with anti-inflammatory properties that may benefit patients with COVID-related inflammatory conditions.