Benzinga | Aug 30, 2021 08:19AM EDT

Biomerica Says Expects Completion Of Patient Enrollment For InFoods Diagnostic-Guided Therapy Irritable Bowel Syndrome Clinical Trial this week

Biomerica Inc. (NASDAQ:BMRA) today announced it expects final patient enrollment in its endpoint clinical trial for its InFoods(r) 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(r) 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(r) 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(r) 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(r) 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(r) 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(r) 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(r) IBS products. Research, conducted by a leading independent pharmaceutical marketing research firm, determined that up to 95% of physicians surveyed would utilize the InFoods(r) DGT depending on the IBS subclass.

Importantly, the InFoods(r) DGT can be used without or in conjunction with current pharmaceuticals to potentially improve patient outcomes. Since the InFoods(r) 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(r) IBS therapy."