BioRestorative Therapies Presents Promising Data at Orthopaedic Research Society (ORS) 2024 Annual Meeting
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Insights
The preliminary data from the phase 2 clinical trial of BRTX-100, presented by BioRestorative Therapies, suggests promising outcomes in the treatment of chronic lumbar disc disease (cLDD). The utilization of autologous hypoxic mesenchymal stem cells is particularly innovative, as it aims to replicate the low oxygen environment of the intervertebral disc to increase cell viability. The positive trends observed in patient-reported outcomes, including the VAS, ODI, RMDQ and FRI, are significant because these metrics directly reflect the patient's perception of pain and disability, which are critical endpoints for regulatory approval.
Importantly, the absence of notable safety signals at this stage is a positive indicator for the continuation of the trial. However, the true efficacy and safety profile of BRTX-100 will only be fully understood upon the unblinding of the study and peer-reviewed publication of the results. The potential for BRTX-100 to become the first orthobiologic approved for disc-related pain represents a significant advancement in a market where current treatments are often invasive and not always effective.
For investors, the progress of BioRestorative Therapies' BRTX-100 through phase 2 clinical trials is a critical value inflection point. The therapy's success could tap into a large market segment, as cLDD is a prevalent condition that affects a substantial portion of the population. The indication of a positive trend in clinical outcomes can be a strong catalyst for the company's stock performance, especially if these results translate into a competitive advantage over existing treatments.
As the company approaches the possibility of submitting a Biologics License Application (BLA) to the FDA, investors should monitor the ongoing data readouts and the competitive landscape, including the activities of companies like Mesoblast and Brainstorm Cell Therapeutic. A successful BLA submission and subsequent approval could lead to significant revenue growth for BioRestorative Therapies. However, the inherent risks of clinical development and the regulatory process should be carefully weighed, as any setbacks could adversely affect the company's financial position and stock valuation.
The market for treatments of chronic back pain is both large and underserved, with many patients seeking alternatives to surgery and long-term pain medication. The development of BRTX-100 by BioRestorative Therapies could meet a substantial unmet need if proven effective and safe. The product's personalized treatment approach aligns well with current trends in healthcare towards individualized medicine.
Should BRTX-100 gain FDA approval, it could disrupt the current treatment paradigm and capture significant market share. The long-term impact on the market would depend on factors such as cost, accessibility and adoption by healthcare providers. The potential for a less invasive and quicker therapeutic application could also lead to increased patient preference for BRTX-100 over more traditional therapies, thereby influencing market dynamics in the sector of non-surgical interventions for back pain.
MELVILLE, NY / ACCESSWIRE / February 14, 2024 / BioRestorative Therapies (NASDAQ:BRTX) is a clinical-stage biotech company that is developing cell-based therapies to treat chronic lumbar disc disease and metabolic conditions such as obesity and diabetes. The company is focusing on developing BRTX-100, its lead therapeutic candidate for the treatment of patients with chronic lower back pain caused by degenerative disc disease. According to experts, up to
The company recently presented data at the Orthopaedic Research Society (ORS) 2024 Annual Meeting. The presentation was titled "Autologous Stem Cell Therapy for Chronic Lumbar Disc Disease; Initial Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells," and it discussed the most recent clinical study.
Previous clinical studies have highlighted the potential impact of the disc's harsh microenvironment on cell viability, which may lead to non-efficacious outcomes or adverse reactions. In order to address this harsh microenvironment, BRTX-100 has been formulated using stem cells that are manufactured using low oxygen to mimic the low oxygen environment found in the disc. BRTX-100 is currently being tested in a phase 2, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States.
Although the data presented is still blinded and at an early stage, it is noteworthy that the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMDQ) and Functional Rating Index (FRI) collected at 26 and 52 weeks after injection indicate a positive trend compared to the baseline. These pain and function questionnaires are used to determine if there have been improvements at weeks 2, 12, 26, 52, and 104 after treatment. In addition to safety, improvements as measured by changes in pain and function play a crucial role in the evaluation of BRTX-100 by the U.S. Food and Drug Administration (FDA) for potential approval of a Biologics License Application (BLA).
"We are thrilled with the progress of our ongoing clinical development programs. With regard to the Phase 2 study investigating the use of BRTX-100 in the treatment of cLDD, we are strongly encouraged by the preliminary data presented at ORS 2024. The preliminary clinical data shows meaningful signals in patients enrolled in the study and, importantly, no notable safety signals," shared Lance Alstodt, Chief Executive Officer of BioRestorative.
BRTX-100 involves the use of autologous hypoxic mesenchymal stem cells and autologous platelet lysate, making it a personalized treatment option. If the company is successful with FDA approval, the candidate could be revolutionary for patients struggling with chronic back pain and become the first orthobiologic approved for disc-related pain. BRTX-100 is unique in its potential to offer patients a less invasive and quicker therapeutic application. BRTX-100 involves a minimally invasive bone marrow and blood harvest procedure, with a collection time of only 20 minutes and a recovery time of approximately one day.
Other companies competing in the cell-based biologics or chronic pain treatment space include Mesoblast, Brainstorm Cell Therapeutic and Longeveron.
To learn more about BioRestorative, visit its website.
Featured photo by david Griffiths on Unsplash.
Contact:
Investor Relations
ir@biorestorative.com
SOURCE: BioRestorative Therapies, Inc.
View the original press release on accesswire.com
FAQ
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