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Wednesday, 07 July 2021 14:07

Bonus BioGroup demonstrated significant improvement in parameters indicating reduced tissue damage, including muscle tissue, in addition to alleviating pneumonia in severe Covid-19 patients treated with the advanced cell therapy product MesenCure

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In view of the spread of new variants of coronavirus, reduced vaccine effectiveness, and the imminent rise in Covid-19 incidence;
Bonus BioGroup demonstrated significant improvement in parameters indicating reduced tissue damage, including muscle tissue, in addition to alleviating pneumonia in severe Covid-19 patients treated with the advanced cell therapy product MesenCure


Bonus BioGroup (TASE: BONS) is a clinical-stage Israeli biotechnology company, engaged in research and development of biomedical tissue-engineered and cell therapy products.

Following the Company's report, dated May 27, 2021[1], regarding complete success in the treatment of severe Covid-19 patients and the demonstration of significant improvement in their condition following treatment with Bonus BioGroup's advanced cell therapy product, MesenCure;

Bonus BioGroup is pleased to announce it has obtained results demonstrating improvement in patients' parameters associated with improved prognosis and increased recovery and survival chances, already from the first MesenCure dose, as well as the reduced risk of multiorgan dysfunction, heart and kidney injuries, and venous thromboembolism (VTE) with a cumulative effect following multiple doses.

These results were obtained after the Company completed an additional analysis of the results obtained thus far in the clinical trial evaluating the safety and efficacy of the cell therapy MesenCure in the treatment of severe Covid-19 patients suffering from life-threatening pneumonia and respiratory distress (hereinafter: "the clinical trial for the treatment of respiratory distress") that is held at Rambam Health Care Campus, Haifa, Israel.

All patients treated with MesenCure were in a severe condition before treatment. In addition, except for one patient, all of them suffered from comorbidities known as risk factors for poor prognosis, complications, and mortality of over 35%[2].

Inflammation and tissue damages are detected in severe Covid-19 patients not only in the lungs but also in the heart and the kidneys at a rate more than ten times higher compared to milder patients[3], as well as VTE, which can collectively lead to multiorgan dysfunction and death, regardless of respiratory distress.

The additional analysis of the results[4] demonstrated a cumulative improvement following each of the three MesenCure doses, starting from the first dose, in clinical parameters indicating reduced tissue damage and less inflammation.

It was found that following each MesenCure dose, the level of the inflammatory protein CRP in patients' blood was decreased by an average of 29%-34%, and up to 92% in total, relative to the maximum level of this protein as measured for each patient, at a statistical confidence level of above 99% (p<0.0001, R2=0.8041). High blood CRP levels in Covid-19 patients are associated with more severe disease, at a rate 2.8 times higher than patients with CRP levels below than median, and 2.6 times higher mortality rate and an increased risk of renal damage and VTE by 2.1- and 2.3-fold, respectively[5].

Similarly, MesenCure doses reduced creatine kinase (CK) levels in the patients' blood by an average of 20%-22%, each dose, for a total reduction of up to 62% relative to the maximum level of this protein as measured for each patient, and at a statistical confidence level of above 99% (p<0.01, R2=0.6720). High blood CK levels indicate muscle tissue damage, including of the heart muscle, and in Covid-19 patients, it is associated with more severe disease with up to three times higher mortality rates.[6]

Similar results were obtained for other markers whose level in the blood, outside the norm, indicates a more severe disease, such as a high level of the enzyme lactate dehydrogenase (LDH)[7], which also indicates extensive tissue damage.

The healed lungs of the treated patients highlighted the superior efficacy of MesenCure, compared to other treatments, and was reflected in a significant (p<0.0001) and rapid reduction in the area of ​​diffuse lung inflammation. This reduction was demonstrated by chest radiographs, from a median of approximately 55% of the lung area before treatment to a median of approximately 15% of the lung area, only five days after starting the treatment, and up to a negligible 1% of the lung area, about a month after treatment began.

The improvement in respiratory function of the Covid-19 patients treated with MesenCure was demonstrated in the significant increase (p=0.0086) in the blood oxygen saturation levels (SpO2) of patients starting with acute respiratory distress before MesenCure treatment and ending with SpO2 levels of about 95% after the treatment.

In addition to improvements in the objective parameters of the patients treated with MesenCure, improvements were also noted in all subjective parameters indicative of the patients' well-being, including their mobility, ability for self-care and performing routine activities, degree of pain and anxiety (p=0.02), and the patients' assessment regarding their overall well-being, which improved by more than 11 points on average (p=0.02), as evident from questionnaires answered by the trial participants before the treatment and about two weeks after treatment with MesenCure.

Dr. Shadi Hamoud, the principal investigator of the clinical trial for the treatment of respiratory distress, is the deputy director of the department of internal medicine E, at Rambam Health Care Campus, stated that: "the treatment results with MesenCure, thus far, are very impressive and are significantly better compared to the results achieved with other therapies. All patients treated with MesenCure were in a severe condition, suffering from acute respiratory distress, diffuse pneumonia as per chest radiographs, and blood parameters indicative of a cytokine storm. Moreover, about 90% of the trial participants suffered from comorbidities known as risk factors for increased disease severity, complications, and mortality. These patients' prognosis was poor, with low chances of recovery and survival, hasn't it been for MesenCure. However, thanks to the treatment with Bonus BioGroup's MesenCure, the patients have shown significant improvements in tested parameters and were released from the hospital only one day (median calculation) following treatment end. Thus, the treatment with MesenCure showed good and surprising results and created great interest among other hospital departments. We hope to treat a large number of patients with this cell therapy, and we will strive to extend its use to other indications as well".

As a result of the excellent outcomes in the phase I clinical trial for the treatment of respiratory distress, demonstrating the safety of MesenCure in all treated patients and tested parameters, the Israel Ministry of Health (IMOH) approved the continuation of the trial to phase II. This phase will include up to 50 additional severe Covid-19 patients. Phase II will be conducted at Rambam Health Care Campus, a leading medical facility in Israel and specifically in the treatment of Covid-19 patients with the help of Prof. Tony Hayek, director of the department of internal medicine E, and under the supervision of his deputy Dr. Shadi Hamoud, the primary investigator in this clinical trial.

In phase II clinical trial, the safety and efficacy of MesenCure will be evaluated for the treatment of Covid-19 patients with life-threatening respiratory distress compared to a control group.

During the clinical trial for the treatment of respiratory distress, the experiment group will receive intravenously three doses of MesenCure. The parameters that will be evaluated include, among others: respiratory functions, inflammatory parameters that indicate the attenuation of the cytokine storm characteristic of the disease, general parameters that indicate the course of the disease, the shortening in the hospitalization period, and the increase in patient survival.

The effectiveness of the cell therapy MesenCure stems from enhancing the mesenchymal cells in MesenCure by an innovative and unique combination of biological and physical growth conditions while reducing the growth period of the cells and improving their safety.

The cell therapy MesenCure is intended to treat life-threatening respiratory distress, whether caused by the original coronavirus strain or any other strain, by another virus, or whether a bacterial or other infection causes it. Therefore, Bonus BioGroup estimates that in the immediate term, vaccines will have no significant effect on the market positioning of MesenCure. This premise is underlined by the growing risk for further Covid-19 waves due to the emergence of more aggressive coronavirus strains[8] and due to a global shortage of vaccines that is expected to last several years, until about 70% of the world's population is vaccinated, which is, according to experts, the minimal requirement for herd immunity.[9]

The Company estimates that even after herd immunity is established, millions of severe coronavirus patients are expected worldwide every year, all of which may be a potential target for MesenCure therapy. This assessment is based on experts' opinions published last January in the prestigious scientific journal Nature. These experts estimate that despite the vaccines, Covid-19 will not disappear but will become endemic with a stable incidence[10] similar to influenza, affecting more than 10% of the population every year.[11]

In addition, the cell therapy MesenCure may be used to treat a wide range of indications, including lower respiratory tract inflammations as well as asthma and chronic obstructive pulmonary disease, which together represent a global market expected by 2026 to exceed US$ 43 billion per year,[12],[13],[14] even before the expected impact of the novel coronavirus.

Since its establishment, Bonus BioGroup is developing 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, isolated from the adipose tissue of healthy donors, and their priming to enhance their potential to attenuate the inflammatory responses, and foremostly, respiratory inflammations and the hyper-inflammatory response (i.e., cytokine storm) seen in Covid-19 and other diseases.

Bonus BioGroup applied in the development of MesenCure a variety of unique technologies and knowledge, some of which are currently in development by the Company, and some of which are part of the Company's wealthy intellectual property estate, which includes fourteen approved patents and eighteen patent applications, in many countries around the world.

Company estimations regarding the 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.

Sincerely,

Bonus BioGroup

By: Yossi Rauch (Chairman of the Board) and Dr. Shai Meretzki (CEO and Director)

 

[1] Reference 2021-01-091323

[2] According to a meta-analysis of 52 observational studies on more than 43,000 severe corona patients, with similar medical condition to the clinical trial participants. https://associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15425

[3] http://www.aginganddisease.org/EN/10.14336/AD.2020.0520

[4] By multivariate linear regression, taking into account the time from the first administration, as a continuous variable, and separating its effect from the number of doses administered (0 to 3) as categorical regression variables (dummy variables).

[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928982/

[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877870/

[7] https://pmj.bmj.com/content/early/2021/01/14/postgradmedj-2020-13954 2

[8] https://www.usatoday.com/story/news/health/2021/02/16/covid-19-us-fourth-wave-variants-coronavirus/4460958001/

[9] https://www.washingtonpost.com/business/2020/05/11/coronavirus-vaccine-global-supply/

[10] Phillips, N., The coronavirus is here to stay - here's what that means. Nature, 2021. 590(7846): p. 382-384.

[11] https://www.cdc.gov/flu/about/burden/2018-2019.html

[12] https://www.coherentmarketinsights.com/press-release/global-chronic-obstructive-pulmonary-disease-copd-treatment-market-to-surpass-us-218-billion-threshold-by-2026-1411

[13] https://www.bloomberg.com/press-releases/2019-06-13/global-asthma-therapeutics-market-to-surpass-us-20-4-billion-by-2026-coherent-market-insights

[14] https://www.reportsanddata.com/report-detail/acute-respiratory-distress-syndrome-ards-market

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