Bonus BioGroup
Press Room

Wednesday, 24 November 2021 04:40

MesenCure treatment resulted in a survival rate of 94% of the severe patients treated and reduced their hospitalization period by about half

Rate this item
(0 votes)

Analysis of results obtained from a phase II, multi-center clinical trial in severe Covid-19 patients treated with Bonus BioGroup's drug product MesenCure, showed that;

MesenCure treatment resulted in a survival rate of 94% of the severe patients treated and reduced their hospitalization period by about half


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 an immediate report from October 11, 2021[1], regarding the treatment completion in the phase II multi-center clinical trial for the treatment of severe Covid-19 patients suffering from life-threatening pneumonia and respiratory distress, using Bonus BioGroup's drug product MesenCure, (hereinafter: "The clinical trial for respiratory distress"), the company is pleased to announce that the survival rate of the 50 hospitalized, severe Covid-19 patients who participated in the clinical trial and received MesenCure, at the end of the thirty days follow-up period, was 94% (47 of 50).

For each of the first 30 participants in the clinical trial for the treatment of respiratory distress, two severe patients with similar characteristics of sex, age, and comorbidities who met the inclusion criteria of the clinical trial, were algorithmically selected to the control group. The control group patients did not receive MesenCure, but the best standard of care according to their condition. From a final analysis of the data, the following main findings emerge:

  • MesenCure treatment reduced about 70% of severe Covid-19 patients' mortality compared with the mortality in the control group. This efficacy was demonstrated by the fact that only 6.7% of the first thirty severe Covid-19 patients treated with MesenCure (two of them) died due to Covid-19 or its complications. In comparison, 23.3% of the control group consisting of 60 similar patients (14 of them) died of Covid-19 or its complications.
  • MesenCure shortened the hospitalization period of severe Covid-19 patients by eight days on average, a reduction of 45% relative to the control group. This reduction in hospitalization days was highly statistically significant (p=0.0022)[2]. It was demonstrated by an average hospitalization period of the severely ill patients treated with MesenCure of 9.4 days only, compared with 17.2 days, on average, for severe Covid-19 patients in the control group.
  • About half of the severe Covid-19 patients treated with MesenCure were discharged from the hospital up to just one day after the end 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.

The success of MesenCure indicates a value proposition reflected in its effectiveness in treating severe Covid-19 patients at risk of death and relieving hospitals' burden and savings insurers (HMOs) costs.

Reducing the number of hospitalization days of severely ill patients treated with MesenCure will free up hospital and ICU beds, among others. Furthermore, it will allow hospitals to better care for other patients, which may help health systems cope with the burden of severely ill patients. In addition, reducing the number of hospitalization days may save about 40%, on average, of the immediate hospitalization and treatment costs of hospitalized, severe Covid-19 patients. The company estimates that these immediate savings could amount to about US$ 30,000 to 40,000 per patient (in the US)[3].

Moshe Bar Siman Tov, former General Manager of the Israeli Ministry of Health, stated, “Returning from Covid-19 epidemic to a daily routine is contingent on a strategy that combines three protection layers. First of all, vaccines, designed to protect the healthy population from infection with the virus and illness, alongside at-home medications for mild Covid-19 patients designed to reduce the risk of severe illness and hospitalization, and no less important are medications for hospitalized, severe Covid-19 patients, such as MesenCure, intended to treat pneumonia and cytokine storm that leads to acute respiratory distress and death. A strategy combining these three layers could also reduce health care burden and importantly, save lives”. 

Vaccines reduce but do not entirely prevent Covid-19 infection and severe illness, which is also the case with medications designed for at-home treatment of mild Covid-19 that may reduce but not prevent hospitalization and severe illness. Therefore, in the absence of complete protection, it remains necessary to provide a therapeutic option for hospitalized, severe Covid-19 patients.

The effectiveness of at-home medications for mild Covid-19 patients is conditional on taking them within a few days of symptoms onset, which may prove particularly challenging in real-world conditions when not as part of a controlled clinical trial. Consequently, hundreds of thousands of severe Covid-19 patients may be left, every year, without an effective treatment option, apart from MesenCure.

Effectively, the benefits of treating severe patients with MesenCure, relative to the currently available best standard of care for severe Covid-19 patients, could be even more profound than reflected in the results of the clinical trial for treating respiratory distress, for two reasons:

  • First, about one-third of the severe Covid-19 patients treated with MesenCure were discharged from the hospital on the day the treatment ended and were eligible to be discharged even before receiving the third and last drug dose. Instead, they remained in the hospital to complete the clinical trial treatment plan. It follows that in real-world conditions, the reduction in the hospitalization days of severe Covid-19 patients treated with MesenCure could be even more significant than in the clinical trial.
  • In addition, the efficacy of MesenCure was measured compared to patients who received the best standard of care available today in the state of Israel. However, the mortality rate from Covid-19 in Israel is lower than in the United States or worldwide due to Israel's high-quality standard of care. Therefore, the reduction in the mortality and hospitalization days of patients treated with MesenCure could be even more significant in most countries worldwide than in the clinical trial conducted in Israel.

To emphasize the success of MesenCure in reducing severe Covid-19 mortality rates compared to the control group, we should note the following: Anti-inflammatory drugs, such as Actemra[4], which in combination with steroids, are currently the best standard of care option for severe Covid-19, have managed, in combination, only to slightly reduce the mortality of hospitalized Covid-19 patients, from 25.8% to 21.8%, in a follow-up period of 28 days[5].

This data indicates that MesenCure is at least 4 (!) times more effective than the best currently available standard of care for severe Covid-19 patients[6].

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 epidemic 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."

MesenCure treatment was found safe in all severe patients who received the medication in the clinical trial for the treatment of respiratory distress with no adverse events assessed to be related to the treatment with MesenCure.

The experimental group included women and men, at a similar ratio, aged 41.4 to 77.4 years. About 77% of the severe Covid-19 patients treated in the hospital with MesenCure suffered from one or more of four diseases known as risk factors for poor prognosis and/or excess mortality, including hypertension, hyperlipidemia, obesity (BMI>30), and type 2 diabetes. Moreover, most of the severe Covid-19 patients who received MesenCure were treated during the fourth Covid-19 wave in Israel that was dominated by the delta strain of the virus, known to be more violent than its predecessors.

Prior to treatment with MesenCure, all patients enrolled in the clinical trial for respiratory distress were diagnosed with severe Covid-19, suffering from diffuse pneumonia and a blood oxygen saturation of 93% or less. The patients in the test group received up to three doses of MesenCure, intravenously, in addition to the best standard of care according to their condition.

The success of the clinical trial for respiratory distress, despite the high prevalence of additional risk factors on top of Covid-19 among the severely ill hospitalized Covid-19 patients treated with MesenCure, highlights MesenCure potential efficacy in diverse patient populations. Even in populations of patients facing a particularly dismal prognosis, regardless of the coronavirus strain that started their disease.

The control group included women and men, at a similar ratio as the test group, aged 41.0 to 77.9 years, with average age and distribution similar to those in the test group. In addition, the rate of comorbidities among the patients in the control group was similar to or lower than their rate in the test group, ensuring no bias in the results in favor of the test group.

The reliability of the control group is further evidenced by a mortality rate of 23.3% recorded among the patients in this group, which corresponds to the mortality rate of severe Covid-19 patients reported in the literature[7].

The data emerging from the clinical trial for the treatment of respiratory distress were presented to members of an independent expert committee, advising Bonus BioGroup on the analysis of the clinical trial results. After confirming the findings from the second phase of the clinical trial, the committee recognized their importance and recommended continuing towards the third phase of the trial.

The parameters examined in the clinical trial include, among others: respiratory functions, inflammatory parameters indicating the attenuation of the cytokine storm characteristic of the disease, general parameters indicating the course of the disease, shortening of the hospitalization period, and the increase in patients' survival. The company will continue to analyze the data collected from all 50 patients who participated in the second phase of the clinical trial for the treatment of respiratory distress.

About the drug product MesenCure

MesenCure is designed to treat life-threatening respiratory distress, whether caused by the original strain of the Covid-19 virus or any other variant or another virus, and whether it is due to a bacterial or other infection.

The efficacy of MesenCure, as evidenced by the clinical trial results, stems from the activation of the mesenchymal cells comprising the drug product. This activation enhances the cells' natural ability to treat pneumonia and alleviate the cytokine storm leading to acute respiratory distress in severe Covid-19 patients.

MesenCure does not act against the coronavirus itself but treats its negative consequences. Thus, to succeed, the treatment with MesenCure is not required to begin within just a few days after the disease symptoms onset. This is in contrast to the at-home medications for mild Covid-19 patients, which effectiveness depends upon treatment start within the first five days after symptoms onset, before the development of pneumonia and cytokine storm.

According to the company's estimations, it is also likely that the efficacy of MesenCure will be less affected by the emergence of new virus variants, which may lead to resistance to treatments directed against the virus itself, 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 at-home medications that work in a single mechanism.

According to the company's estimations, the growing involvement of pharma giants in the at-home treatments market for mild Covid-19 highlights the position of MesenCure in the treatment of hospitalized, severe Covid-19 patients.

About Bonus BioGroup

Since its establishment, Bonus BioGroup has been engaged in cellular medicine and tissue engineering to achieve bone tissue regeneration and reconstruction. The central building block utilized to produce the viable bone graft is mesenchymal cells isolated from the patient's adipose tissue. With the outbreak of the Covid-19 pandemic, the company began experimenting with the same mesenchymal cells, which are isolated from adipose tissue of healthy donors and activated to intensify their potential to attenuate inflammation and the cytokine storms prevalent in Covid-19 and other infections.

In the development of MesenCure therapy, Bonus BioGroup applies a variety of unique technologies and know-how developed in the company. The company's rich intellectual property includes seven patent families and patent applications, containing twenty-five approved patents and twenty patent applications worldwide.

Company estimations regarding the forward-looking statement

Bonus BioGroup's assessments regarding the therapeutic effect and /or the marketing potential of the drug product MesenCure, the company's ability to continue the development of the drug, including the conduct of clinical trials, and the manufacturing of a high-quality clinical-grade drug product, 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 Ltd.

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

 

[1] Reference 2021-01-086311.

[2] According to T-Test, two-tailed, assuming unequal variances.

[3] According to average hospitalization days and costs for severe Covid-19 patients in the United States.

[4] Actemra is a brand name of a drug (tocilizumab) manufactured by F. Hoffmann-La Roche AG.

[5] Matthay MA, Luetkemeyer AF. IL-6 Receptor Antagonist Therapy for Patients Hospitalized for COVID-19: Who, When, and How? JAMA. 2021;326(6):483–485. doi:10.1001/jama.2021.11121

[6] MesenCure was calculated to be 4.6-times more effective than the drug Actemra in reducing the mortality of severe Covid-19 patients based on the ratio between MesenCure effectives (71.2%), calculated as one minus the ratio between the mortality rate in MesenCure test group (6.7%) and the mortality rate in the control group (23.3%), and the effectives of Actemra (15.5%), similarly calculated based on data from Matthay et al. (2021) on the mortality rates in Actemra test group (21.8%) and control group (25.8%).

[7] Oliveira, Eduardo et al. “ICU outcomes and survival in patients with severe COVID-19 in the largest health care system in central Florida.” PloS one vol. 16,3 e0249038. 25 Mar. 2021, doi:10.1371/journal.pone.0249038.

Read 517 times Last modified on Thursday, 25 November 2021 04:43

FOR MORE INVESTOR RELATION INFORMATION

Press Release, Announcements publication and more

Bonus BioGroup

Image

 

Terms of UsePrivacy Policy | Login        

© 2021 Bonus BioGroup Ltd. All Rights Reserved. Designed By Netron Israel Ltd.