Biomerica expects Completion of Patient Enrollment for its InFoods® Diagnostic-Guided Therapy Irritable Bowel Syndrome Clinical Trial this week
August 30 2021 - 8:19AM
Biomerica Inc. (NASDAQ: BMRA) today announced it expects final
patient enrollment in its endpoint clinical trial for its InFoods®
diagnostic-guided therapy (DGT), designed to alleviate Irritable
Bowel Syndrome (IBS) symptoms. The clinical trial is being
conducted by Mayo Clinic, Beth Israel Deaconess Medical Center
Inc., a Harvard Medical School Teaching Hospital, Houston Methodist
hospital and the University of Michigan as primary enrollment
centers for this study.
Biomerica expects the final patients enrolled in the endpoint
trial to complete treatment by the end of October, after which the
study data locked and final statistical analysis will be performed.
Top-line trial results showing the efficacy of the InFoods® IBS
product are expected by year end.
It is estimated that over 40 million Americans suffer from IBS
and the symptoms are often triggered by consumption of specific
foods (which are unique in each sufferer). The total cost (direct +
indirect) of IBS has been estimated at $30 billion annually in just
the United States. IBS is a common condition that can substantially
impair a patients physical and mental well-being, and their ability
to function both at home and in the workplace.
This endpoint trial is a double-blinded, randomized, controlled
clinical trial using the InFoods® IBS test to manage the
debilitating pain and suffering of patients diagnosed with IBS. The
trial evaluates improvements in nine different endpoints (IBS
symptoms) in patients using of the InFoods® diagnostic guided
therapy. It also stratifies enrollment by the three main IBS
subclasses (IBS-Constipation, IBS-Diarrhea and IBS-Mixed). There is
currently no FDA cleared therapy for IBS-Mixed. InFoods® IBS
utilizes an antibody guided blood test to identify patient-specific
foods that may alleviate IBS symptoms when eliminated from the
diet.
Pending a positive outcome from this endpoint trial, Biomerica
will meet with FDA prior to initiating a final pivotal trial
focused on the endpoint(s) that show the greatest improvement in
the current trial. This pivotal trial would form the basis apply
for FDA clearance for the product. The InFoods® IBS study design
has already received a non-significant risk determination from FDA,
which should expedite the final approval process.
A clinical lab version of the product is being used in the
endpoint clinical trial. However, the Company is also developing
InFoods® IBS DGT as a point-of-care product that allows physicians
to perform the test in-office using a finger stick blood sample. A
billable CPT code that can be used by both clinical labs and
physicians' offices is already available for the InFoods® IBS
products. Research, conducted by a leading independent
pharmaceutical marketing research firm, determined that up to 95%
of physicians surveyed would utilize the InFoods® DGT depending on
the IBS subclass.
Importantly, the InFoods® DGT can be used without or in
conjunction with current pharmaceuticals to potentially improve
patient outcomes. Since the InFoods® product is a diagnostic-guided
therapy and not a drug, it has no drug-type side effects. Zackary
Irani, Chief Executive Officer of Biomerica, commented: “This
ground-breaking new therapy that combines science, technology and
diet could revolutionize how IBS patients are treated. By focusing
on eliminating the cause of patient’s suffering rather than simply
treating their symptoms I believe we can improve the lives of tens
of millions of IBS sufferers around the world. Further, we are
excited to expand our patented InFoods Technology Platform into
treating patients suffering from other diseases, whose symptoms
appear to be caused or exacerbated by specific foods in their
diets.”
Mr. Irani concluded, “With this pending trial completion, we are
now beginning the licensing/partnering discussions process with
global health sciences, pharmaceutical and medical device
companies, that can expedite the final pivotal trial, FDA clearance
and global commercialization of the InFoods® IBS therapy.”
About Biomerica (NASDAQ: BMRA) Biomerica, Inc.
(www.biomerica.com) is a global biomedical technology company that
develops, patents, manufactures and markets advanced diagnostic and
therapeutic products used at the point-of-care (in home and in
physicians' offices) and in hospital/clinical laboratories, for
detection and/or treatment of medical conditions and diseases. The
Company's products are designed to enhance the health and
well-being of people, while reducing total healthcare costs.
Biomerica primarily focus is on Gastrointestinal and inflammatory
Diseases where the Company has multiple diagnostic and therapeutic
products in development.
The Private Securities Litigation Reform Act of 1995 provides a
"safe harbor" for forward-looking statements. Certain information
included in this press release (as well as information included in
oral statements or other written statements made or to be made by
Biomerica) contains statements that are forward-looking, such as
statements relating to the efficacy of the Company’s Covid product,
hp-detect Product and other tests, FDA clearance of the Company’s
products including the InFoods and hp-detect product, expected
completion of clinical trials, first of a kind therapy, FDA and CE
Mark clearance of these products, the rapidity of testing results,
uniqueness of the Company’s products, test result accuracy of
products, pricing of the Company’s test kits, demand for domestic
or international orders, potential revenues from the sale of
current or future products, availability of the Company’s test
kits, patent protection and freedom to operate on any of the
Company’s products or technologies, future production costs and
overhead, sales and administrative costs, R&D expenditures,
materials costs, needed inventory reserves, collectability of
receivables, legal costs and other extraordinary costs. Such
forward-looking information involves important risks and
uncertainties that could significantly affect anticipated results,
in the future, including, without limitation: impacts on earnings
and other financial results; results of studies testing the
efficacy of the Company’s InFoods tests and other products;
regulatory approvals necessary prior to commercialization of the
Company’s products; the Company’s ability to license its products
or partner with others for the commercialization of its products;
availability of the Company’s test kits and other products;
capacity, resource and other constraints on our suppliers;
dependence on our third party manufacturers; dependence on
international shipping carriers; governmental import/export
regulations; demand for our various tests and other products;
competition from other similar products and from competitors that
have significantly more financial and other resources available to
them; governmental virus control regulations that make it difficult
or impossible for the company to maintain current operations;
regulations and the Company’s ability to obtain patent protection
on any aspects of its rapid test technologies. Accordingly, such
results may differ materially from those expressed in any
forward-looking statements made by or on behalf of Biomerica.
Additionally, potential risks and uncertainties include, among
others, fluctuations in the Company's operating results due to its
business model and expansion plans, downturns in international and
or national economies, the Company's ability to raise additional
capital, the competitive environment in which the Company will be
competing, and the Company's dependence on strategic relationships.
The Company is under no obligation to update any forward-looking
statements after the date of this release.
CONTACT INFORMATION
Corporate Contact:
John Nesbett /Jennifer BelodeauIMS Investor
Relations203.972.9200jnesbett@institutionalms.com
Source: Biomerica
1 Canavan et al. The epidemiology of irritable bowel syndrome
Clin Epidemiol. 2014; 6: 71–80. doi: 10.2147/CLEP.S40245
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