Tel Aviv, Israel--(Newsfile Corp. - December 2, 2021) - Bonus BioGroup or (TASE: BONS) "the Company", a clinical-stage Israeli biotechnology company engaged in the research and development of biomedical tissue-engineered and cell therapy products, has announced results of phase II clinical trial for MesenCure, the Company's treatment for severe COVID-19. The positive results reported by the Company coincide with the emergence of the highly-mutated Omicron variant that has regalvanized the international community's commitment to developing long-term solutions for the ongoing pandemic.
On October 11, 2021, Bonus BioGroup reported the conclusion of its phase II, multi-center, controlled clinical trial for treating severe COVID-19 patients suffering from life-threatening pneumonia and respiratory distress. On November 25, 2021, the Company announced a 94% survival rate at the end of a 30-day follow-up period for the 50 hospitalized patients who participated in the clinical trial and were treated with MesenCure. The phase II clinical trial data indicate that MesenCure is at least four times more effective than the treatment options for severe COVID-19 patients currently available on the market.
Initial analysis of the phase II clinical trials results has yielded the following highlights:
MesenCure treatment reduced severe COVID-19 patients' mortality by approximately 70% in comparison to the control group.
MesenCure shortened the hospitalization period of severe COVID-19 patients by eight days on average, a reduction of 45% relative to the control group. Alternately, the average hospitalization period for severely ill patients treated with MesenCure measured 9.4 days compared to 17.2 days for the control group.
About half of the severe COVID-19 patients treated with MesenCure were discharged from the hospital within a day after the conclusion of treatment. Over a third (36%) of patients treated with MesenCure were discharged from the hospital on the day their treatment ended, and over 60% of them were discharged up to two days after treatment.
MesenCure is designed to treat life-threatening respiratory distress caused not only by the original strain of the COVID-19 virus but also other variants thereof and non-COVID bacterial and viral infections. The efficacy of MesenCure, as evidenced by the clinical trial results, stems from the activation of the mesenchymal cells comprising the product. This activation enhances the cells' natural ability to treat pneumonia and alleviate the cytokine storm that leads to acute respiratory distress affecting severe COVID-19 patients.
A key element of Bonus BioGroup's value proposition is that dramatically reducing the hospitalization period for severely ill COVID-19 patients via treatment with MesenCure will free up hospital/ICU beds, equipment, and medical personnel, thereby reducing the strain on overburdened health systems and enabling better care for other patients. In addition, shorter periods of hospitalization will reduce the economic cost incurred by national health systems, insurance providers, and employers worldwide.
The Company estimates that the net benefit of MesenCure for severe COVID-19 patients relative to the standard of care could be even more profound than reflected in current results for two reasons. First, many of the patients in the trial were clinically eligible to be released from the hospital after the first or second out of the three MesenCure doses administered. Rather than immediate discharge, they remained hospitalized for a longer duration in order to adhere to the clinical trial's protocol. This suggests that under real-world conditions, MesenCure's role in reducing hospitalization days for severe patients could be even more significant than initially observed.
Second, in the clinical trial MesenCure's efficacy was compared to the standard of care available in Israel, which is relatively higher than the world average. This implies that the reduction in mortality and hospitalization days of patients treated with MesenCure on a global scale could be even more significant relative to metrics that were recorded in Israel.
Dr. Shai Meretzki, CEO of Bonus BioGroup, said: "We are proud of our success in leading the world to be a safer place by developing a medication for severe COVID-19 patients, thereby dramatically reducing the threat to their lives. In less than two years from the pandemic's outbreak, we are the first in the world to report an effective and significant treatment for severely ill patients. The clinical trial results are controlled and statistically significant and have far-reaching clinical and economic implications for patients and health systems. Based on these results, the Company shall continue to expand the manufacturing and availability of MesenCure in Israel and around the world, despite the availability of vaccines and the welcomed introduction of medication for mild 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 to study 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.
