Bonus BioGroup Submits Outstanding Phase-II Trial Results for MesenCure, a Treatment for Severe COVID-19, to the Israeli Ministry of Health

Tel Aviv, Israel–(Newsfile Corp. – January 18, 2022) – Bonus BioGroup (TASE: BONS) or “the Company”, a clinical-stage Israeli biotechnology company engaged in the research and development of biomedical tissue-engineered and cell therapy products, submitted results for its multicenter, Phase-II clinical trial to the Israeli Ministry of Health on January 9^th. Following on the heels of the Company’s initial release of encouraging preliminary results in November 2021, the trial data submitted last week further demonstrate the high levels of efficacy and safety previously observed for MesenCure’s treatment of severe COVID-19 patients.

The 50 participants of the controlled clinical trial treated by MesenCure (on top of the best standard of care) suffered from severe COVID-19 characterized by diffuse pneumonia, acute inflammation, blood oxygen desaturation, and life-threatening respiratory distress. The trial outcomes were measured against a control group of 150 similar severe COVID-19 patients treated with the best standard of care.

Given baseline mortality of approximately 20% for such severe COVID-19 patients, MesenCure was found to dramatically reduce trial participants’ mortality rates and duration of hospitalization.

Key findings observed in the Phase-II trial results for severe COVID-19 patients treated with MesenCure include:

• A 68% decrease in the mortality rate and a 57% drop in the number of patients requiring invasive ventilation measured for the severe COVID-19 patients treated with MesenCure compared to control patients.
• A significant reduction in the duration of hospitalization; more than 50% of the patients treated with MesenCure were released from the hospital within two days following treatment. In addition, nearly a quarter (24%) of the patients treated with MesenCure were released from the hospital on the day their treatment ended, and 40% were released up to one day after.
• MesenCure is a safe course of treatment for severe COVID-19; no adverse safety events were observed in the test patients assessed to be related to MesenCure.

Unlike antiviral drugs, recently granted emergency use authorization for treating mild-to-moderate patients, mostly at home, MesenCure is used to treat severe, hospitalized COVID-19 patients. Such severe patients often suffer from comorbidities and complications that increase their risk of hospitalization and death. Moreover, MesenCure’s effectiveness is not likely to be diminished by the emergence of mutated variants of the original COVID strain, as it targets acute inflammation and pneumonia provoked by a cytokine storm rather than the virus directly.

Bonus submits its Phase-II trial results against the backdrop of the ongoing Omicron wave, which has driven a global surge in infections that has outpaced prior waves and threatens to inundate national health systems worldwide. From this position, MesenCure can play a critical role in unburdening strained hospitals and medical staff by reducing the number of patients requiring invasive ventilation, ICU beds, and prolonged hospitalization. In addition, by shortening the period of hospitalization for the most severe patients, the Company projects that the hospital cost of treatment can be decreased by an average of 40%, with immediate savings for the healthcare system expected to fall within the range of $30,000-$40,000/patient.

The Phase-II trials results for MesenCure indicate that it is as much as four-times more effective than alternative treatment options currently on the market for severe COVID-19 cases. The Company is currently working on supplemental analyses of trial data. Moving forward, the Company intends to promote the commercialization of MesenCure by pursuing Phase-III clinical trials in Israel and other countries worldwide.

About MesenCure

MesenCure is designed to treat life-threatening respiratory distress, whether caused by the original strain of the coronavirus or any other variant or virus, and whether it is due to a bacterial infection or another insult. The efficacy of MesenCure, demonstrated in the clinical trial results, stems from the professionalization of the mesenchymal cells comprising the drug product. This professionalization enhances the cells’ natural ability to treat pneumonia and alleviate the cytokine storm leading to acute respiratory distress and death in severe COVID-19 patients.

According to the Company’s estimations, it is likely that MesenCure’s efficacy will not be affected by the emergence of new coronavirus variants. This is in contrast to heightened resistance against treatments targeting the virus itself (as opposed to attenuating hyper-inflammation caused by a cytokine storm) such as vaccines and at-home medication for mild patients. Moreover, the cells that constitute MesenCure affect the inflammation via multiple mechanisms and therefore may have a broader and better effect on diverse patient populations than medications that work via a single mechanism.

According to the Company’s estimations, the growing involvement of pharmaceutical giants in the at-home treatments market for mild-to-moderate COVID-19 highlights MesenCure’s market opportunity, addressing the treatment of severe, hospitalized COVID-19 patients.

About Bonus BioGroup

Since its establishment, Bonus BioGroup has worked to develop cell therapies and tissue-engineered products for bone regeneration. The main component of the viable bone graft developed by the Company are mesenchymal stromal cells isolated from the patient’s adipose tissue. During the outbreak of the COVID-19 pandemic, the Company started studying these mesenchymal cells and their potential applications to attenuate the hyper-inflammatory response (i.e., cytokine storm) provoked by COVID-19 and other diseases. In the development of MesenCure, Bonus BioGroup applied a variety of unique technologies and proprietary knowledge, some of which are currently in development by the Company, and some of which are part of the Company’s broad intellectual property portfolio, which includes fourteen approved patents and eighteen patent applications in many countries around the globe.

Forward-Looking Statement

Bonus BioGroup’s assessments regarding the therapeutic effect of MesenCure and/or its marketing potential, the Company’s ability to continue the development of the drug product, including the conduction of clinical trials, and the attaining of a drug product that can be medically applied in humans, for the time periods expected to conduct any stages in any trial, are a forward-looking statement, as defined by the in the securities law 1968, which is based on the Company’s estimates and on the information in its possession at the time of reporting.

There is no certainty that this information will be realized, in whole or in part, among others, due to dependence on third parties actions that are not under the control of the Company, the possibility of delay in obtaining relevant regulatory approvals, and/or a change in the relevant conditions and/or feasibility studies that the Company may conduct, and/or delay in conducting of studies and/or the need for further studies and/or failure of studies and/or technological changes and/or development and marketing of similar and/or more effective competing products and/or lack of availability of resources and/or realization of any of the risk factors related to research and/or trials and/or its results.

Media Contact

Dr. Shai Meretzki
ShaiMe@bonus-bio.com
+972 50-527-7781
https://www.bonusbiogroup.com

SOURCE: Bonus BioGroup

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