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Monday, 10 January 2022 07:47

Bonus BioGroup applied to the Israeli Ministry of Health for emergency use authorization of the drug MesenCure for severe Covid-19 patients and submitted results of phase II, multicenter, controlled clinical trial, demonstrating outstanding efficacy

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


Bonus BioGroup is pleased to announce that on January 9, 2022, it submitted an application to the Israeli Ministry of Health for an emergency use authorization of MesenCure. This announcement follows an immediate report dated November 24, 2021[1], regarding the completion of phase II multicenter clinical trial for the treatment of hospitalized, severe Covid-19 patients, with diffuse pneumonia, intensive inflammation, blood oxygen desaturation, and life-threatening respiratory distress, with Bonus BioGroup's MesenCure (hereinafter: "the clinical trial for the treatment of respiratory distress").

Upon completion of the results analysis of the controlled clinical trial for the treatment of respiratory distress of 50 severe Covid-19 patients treated with MesenCure in addition to the best standard of care (hereinafter: "the test group"), compared to a group of 150 patients with similar characteristics, including age, gender and known risk factors, which also received the best standard of care treatment for their condition, but were not treated with MesenCure (hereinafter: "the control group"), the following main findings arise:

  • MesenCure was safe in treating severe Covid-19 patients: No adverse safety events assessed to be related to MesenCure were observed in the test patients.
  • MesenCure significantly reduced the mortality of the severe Covid-19 patients by 68%: From 19% mortality in the control group to 6% only in the test group.
  • During a follow-up period of thirty days, starting from the first dose, the survival rate of the severe Covid-19 patients treated with MesenCure was 94%: 47 out of 50 patients.
  • MesenCure significantly reduced the number of severe Covid-19 patients who required invasive ventilation by 57%: From 29.3% ventilated patients in the control group to 12.5% patients that deteriorated to ventilation in the test group.
  • MesenCure considerably shortened the hospitalization of the most severe Covid-19 patients in the test group compared with the control group.
  • More than half of the severe Covid-19 patients treated with MesenCure were released from the hospital within two days following treatment. In addition, about 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.
  • Rapid and significant improvements in pneumonia were observed in severe Covid-19 patients treated with MesenCure, as shown on chest X-rays and reflected in inflammatory and other parameters improvements.

It is estimated that about 20% of severe Covid-19 patients hospitalized in Israel, will die. The clinical trial results show that MesenCure is expected to reduce by 68% the mortality rate of these severe Covid-19 patients, and therefore may save the lives of more than 130 people (68% of about 200 people) of every 1,000 severe Covid-19 patients.

It should be emphasized that antiviral drugs that have received emergency use authorization are intended to treat mild-to-moderate Covid-19 patients, at home, during the first few days after their symptom's onset, while MesenCure is intended for hospitalized, severe patients.

It should also be noted that MesenCure efficacy is not likely to be affected by the different variants of the coronavirus or any other virus. This is because MesenCure does not act directly against the coronavirus but regulates and reduces, by various mechanisms, the acute inflammation and cytokine storm that threaten the lives of severe Covid-19 patients.

To the best of the company's knowledge, MesenCure is the only treatment existing or reported in the literature intended for severe Covid-19 patients, with considerable and significantly proven efficacy.

An independent panel of experts advising the company has determined that MesenCure holds ground-breaking implications for treating severe Covid-19 patients, unique in its effectiveness and devoid of safety risks. Consequently, it was recommended to promote the application of MesenCure as soon as possible for the benefit of future severe Covid-19 patients.

Reducing the number of hospitalization days of the severely-ill patients treated with MesenCure will free up ICU and hospital beds, allowing healthcare providers to better care for other patients and alleviate the burden on healthcare systems.

In addition, reducing the number of hospitalization days can save up to 40%, on average, of the immediate hospitalization and treatment costs of 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)[2].

Returning from the Covid-19 epidemic to a daily routine is contingent on combining three protection layers—first, vaccines, designed to protect the healthy population from infection and illness. Alongside at-home medications to reduce the risk of mild Covid-19 patients deteriorating to severe illness and hospitalization. Finally, and no less important, are medications for hospitalized, severe Covid-19 patients, such as MesenCure, intended to treat pneumonia and cytokine storm, which lead to acute respiratory distress and death. A strategy combining these three layers could reduce the healthcare burden and, importantly, save lives.

Of note, due to a high standard of care, Covid-19 mortality is lower in Israel is than in the United States or most other countries. Therefore, it is likely that MesenCure's relative advantage in reducing the mortality of severely-ill patients and shortening their hospitalization will be more profound, than measured in Israel, in most other countries around the world.

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[3], which in combination with steroids, constitute the best standard of care option for severe Covid-19, have managed 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[4]. 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[5].

In addition to the company's application to the Israeli Ministry of Health for emergency use authorization for MesenCure, the company intends to promote MesenCure commercialization by pursuing emergency use authorization and phase III clinical trials in other countries as well.

The test group included women and men, at a 2:3 ratio, aged 30.1 to 77.4 years. About 82% of the severe Covid-19 patients treated with MesenCure suffered from one or more diseases known as risk factors for poor prognosis and/or excess mortality, including hypertension, hyperlipidemia, smoking, obesity, asthma, heart diseases, 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 variant of the coronavirus, known to be more violent than its predecessors.

The success of the clinical trial in the treatment of respiratory distress, despite the high prevalence of additional risk factors among the severe Covid-19 patients treated with MesenCure, highlights the drug's efficacy in treating diverse patient populations, including patients with particularly poor prognosis, regardless of the variant that caused their disease.

The test group patients received up to three doses of MesenCure, intravenously, in addition to the best standard of care treatment, depending on their condition.

The control group included women and men at a similar ratio as the test group, reflecting age mean and distribution similar to those measured in the test group. In addition, the prevalence of co-morbidities among the control group patients was similar or lower than their prevalence in the test group, guaranteeing no bias in favor of the test group.

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. In addition, the company shall 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

The efficacy of MesenCure, as evidenced by 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.

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

According to the company's estimations, it is also likely that MesenCure's efficacy shall be less affected by new coronavirus variants, which may lead to resistance against treatments directed at 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 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-to-moderate 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 professionalized to enhance their potential to attenuate inflammation and the cytokine storm prevalent in Covid-19 and other infections.

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

Company estimations regarding forward-looking statements

Bonus BioGroup's assessments regarding the mortality rate of severe Covid-19 patients, 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 securities law of 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, future evolvement of the Covid-19 epidemic, 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 their results.

Sincerely,

Bonus BioGroup Ltd.

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

 

[1] Reference 2021-01-170493.

[2] According to average hospitalization periods and costs of severe Covid-19 patients in the US

[3] Actemra is a brand name of tocilizumab manufactured by F. Hoffmann-La Roche AG.

[4] 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

[5] The efficiency of MesenCure was calculated to be 4.4 times greater than the efficiency of Actemra, calculated as a ratio between (1) one less (1a) the mortality rate in the test group (6.0%) divided by (1b) the mortality rate in the control group (18.7%), in MesenCure trial (68.3%); And (2) one less (2a) the mortality rate in the test group (21.8%) divided by (2b) the mortality rate in the control group (25.8%), in the Actemra trial (15.5%).

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