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Bonus Biogroup Announces U.S. Food and Drug Administration (FDA) Clearance of an Investigational New Drug (IND) Application for MesenCure™ Phase III Clinical Study in Respiratory Distress
The Company is working to expand its indication to include patients who have respiratory distress from any cause, including acute respiratory distress syndrome (ARDS)
MesenCure's market potential in all-cause ARDS in the United States alone could reach approximately $9.6 billion by 2030, according to Company estimates
TEL AVIV, Israel, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Bonus Biogroup (TASE: BONS), a late-stage biotechnology company priming immunomodulatory and regenerative mesenchymal stromal cells (MSC) to develop novel tissue engineering and cell therapy solutions, today announced that it has received U.S. Food and Drug Administration (FDA) clearance to proceed with a Phase III clinical study in the United States to evaluate the efficacy and safety of MesenCure™ (allogeneic cell therapy consisting of enhanced adipose tissue-derived MSC) to treat respiratory distress in hospitalized, severely ill patients resulting from pneumonia related to COVID-19. MesenCure is an enhanced cell therapy developed by Bonus Biogroup for treating inflammation and tissue damage.
The Company is working to expand the Phase III clinical study indication to include the treatment of respiratory distress that manifests from any cause, including acute respiratory distress syndrome (ARDS), based on clinical and preclinical findings indicating MesenCure's potential in treating this indication, regardless of its underlying etiology. The IND application is supported, among other factors, by results from a Phase II clinical study of MesenCure completed in 2022. This study demonstrated approximately 68% reduction in the 30-day all-cause mortality rate among hospitalized, severely ill patients with respiratory distress related to COVID-19 pneumonia treated with MesenCure, as well as about 57% decrease in their need for invasive ventilation. Patients treated with MesenCure who had a hospital length of stay exceeding seven days experienced a reduction of approximately 9.4 days, on average, in hospitalization duration compared to the control group.
Dr. Shai Meretzki, Chief Executive Officer of Bonus Biogroup, commented, "Receiving FDA clearance to proceed with a Phase III clinical study of MesenCure in the United States marks a significant milestone in cell therapy and an important achievement for the Company. This is our first approval of its kind for an advanced clinical study in the United States, which we believe underscores the depth of our research, the scientific innovation behind MesenCure, and the substantial investment and extensive efforts that have brought us to this stage. Based on the findings of our Phase II clinical study and additional preclinical studies, we believe that MesenCure has the potential to provide a breakthrough solution for ARDS patients, which, until now, have been addressed through mainly supportive treatments without having a curative option."
Dr. Meretzki continued, "The findings of our Phase II clinical study reinforced our confidence in MesenCure's potential to not only save lives but also significantly alleviate the burden on hospitals and intensive care units, resulting in substantial cost savings. The broad effects observed in our clinical and additional preclinical studies suggest that MesenCure may be effective in treating ARDS, regardless of its underlying cause. We remain committed to advancing the Phase III clinical study with full dedication and making MesenCure accessible as a pioneering medical solution for patients suffering from acute respiratory distress."
About Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome (ARDS) may develop from pneumonia, sepsis, or trauma and can lead to respiratory failure and death. In some cases, pulmonary manifestation or respiratory distress in severely ill patients related to COVID-19 pneumonia is a form of ARDS or may deteriorate to ARDS. Despite advancements in supportive treatments—currently the primary approach to managing ARDS—the syndrome remains associated with high mortality rates, ranging from 27% to 45%. In 2023, approximately 591,000 patients in the United States alone suffered from ARDS, accounting for 10% to 15% of all ICU admissions, imposing a significant economic burden on U.S. healthcare systems. The immediate direct hospitalization costs in ARDS range from $108,000 to $158,000 per patient, with an average hospital stay of 17 to 47 days, including 10 to 39 days in intensive care, where mechanical ventilation is typically required for 8 to 23 days. Additionally, more than 75% of ARDS survivors suffer from long-term complications that severely impact their quality of life, leading to a substantial increase in the longer-term healthcare costs, estimated at $43,000 to $62,000 per patient in the first few years following the illness.
About MesenCure
MesenCure is an allogeneic cell therapy investigational drug comprising enhanced adipose tissue-derived MSC designed to treat inflammation and tissue damage, including pneumonia and respiratory distress. Bonus Biogroup believes MesenCure's therapeutic effect stems from leveraging multiple mechanisms of action, enhanced through a proprietary cell priming process, to mitigate inflammation and promote tissue regeneration. The Company believes that MesenCure's fresh formulation with a seven-day shelf-life may further enhance its utility by simplifying storage and application while addressing the potency loss often associated with cell cryopreservation. A potential advantage of MesenCure in treating respiratory distress, including ARDS, lies in its focus on treating inflammation and restoring lung tissue rather than targeting the underlying causes of inflammation, such as viral or bacterial infections or other insults that may lead to acute lung injury. As a result, MesenCure is expected to maintain its therapeutic activity regardless of the disease trigger and may offer a more effective treatment approach across diverse patient populations.
The Company estimates that the market potential of MesenCure for treating all-cause ARDS in the United States alone could reach approximately $9.6 billion by 2030. This estimate is based on the projected savings in immediate direct hospitalization costs for patients treated with MesenCure, which is estimated at $41,000 per patient on average—a 38% reduction compared to the current minimum direct hospitalization cost of $108,000 per patient. Additionally, the estimate considers a minimum ARDS incidence rate of 66 cases per 100,000 people per year.1
About Bonus Biogroup
Bonus Biogroup Ltd. is a biotechnology company conducting advanced clinical studies focused on developing next-generation therapies in regenerative medicine for cell and tissue regeneration. The company is dedicated to creating effective and safe tissue engineering and cell therapy products to treat common and severe conditions with limited treatment options while ensuring broad accessibility through cost-effective solutions. Bonus Biogroup develops cutting-edge priming technologies to enhance the regenerative capabilities of mesenchymal cells—promoting tissue regeneration and reducing inflammation, as well as advanced methods for cell production.
Based on these technologies, the company has two products in clinical development: the above-mentioned MesenCure, and BonoFill™, a tissue-engineered, live-human-bone graft designed for bone repair, regeneration, and reconstruction. The BonoFill bone graft is based on autologous (patient-derived) cells to minimize the risk of rejection. These cells are cultured in a bioreactor on a 3D scaffold for 2-3 weeks, resulting in a large volume of bone tissue suitable for transplantation. The Company has completed a Phase II clinical study to treat bone deficiencies in the face, demonstrating a 90% success rate and a significant reduction in healing time. Additionally, a Phase II clinical study is underway to treat large bone defects in the limbs. Unlike traditional autologous bone grafting, which is the current standard treatment for critical bone loss, BonoFill eliminates the need for bone harvesting, offering a safer, patient-friendly alternative produced entirely in the lab. Furthermore, the reduced complexity of the surgical procedure using BonoFill may accelerate the healing process.
The development of Bonus Biogroup's clinical-stage products and additional products and applications in the preclinical stage leverages the Company's proprietary technologies and expertise. The Company's strong intellectual property portfolio comprises six patent families, encompassing thirty-nine granted patents and ten pending patent applications, covering multiple countries worldwide.
Forward-Looking Statements
Bonus Biogroup's assessments regarding the medical effect and/or commercial potential of its products and/or the resulting economic opportunities, and the Company's ability to continue the process of their development, including conducting studies and arriving at a product that can be medically applied in humans, for the duration and expected dates to perform any stage in any experiment and publish its results and obtain regulatory approvals for marketing the product, are forward-looking statements, as defined by the Securities Law of 1968, which are based on the Company's estimates and on the information in its possession at the time of reporting. There is no certainty that these estimates will materialize, in whole or in part, among others, due to dependence on the actions of third parties, which are not under the Company's control, on the development of future therapies, on future studies' results, if any, due to the possibility of delay in obtaining approval from relevant authorities and/or change in the relevant conditions and/or feasibility tests that the Company may conduct and/or delay in performing studies and/or need to perform further experiments and/or failure of experiments and/or technological changes and/or the development and/or marketing of similar and/or more efficient competing products and/or the lack of resources and/or the realization of any of the risk factors associated with the research and/or studies and/or its results.
Bonus Biogroup
Investor Relations
Tomer Bronshtein, Ph.D.
Jeremy Feffer
Vice President, Innovation and Corporate Development
An original Hebrew version of the Company's Immediate Report to the Tel Aviv Stock Exchange (TASE) related to the reported matter is available on the TASE website.
_______________ 1 According to the Continuing Education Activity on ARDS by Matthew Diamond et al. (https://www.ncbi.nlm.nih.gov/books/NBK436002/), last updated in January 2024, the estimated incidence of ARDS in the United States ranges from 64.2 to 78.9 cases per 100,000 person-years. Based on the Company’s analysis of additional sources, this estimate has been further refined to 66 cases per 100,000 person-years.
