FDA Grants Orphan Drug Designation to Biompharma’s Bi104, a microbiome-modifying biologic, for the treatment of Angelman Syndrome
Sarasota, FL – BIOM Pharmaceutical Corporation is thrilled to announce that Bi104, its innovative drug product, has been granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of Angelman syndrome (AS).
Angelman Syndrome (AS) is a rare neurodevelopmental disorder characterized by developmental delay, intellectual disability, speech impairment, and motor abnormalities. It affects approximately 1 in 20,000 individuals worldwide.
Currently, there is no specific treatment approved for preventing or controlling AS. The only options consist of managing the symptoms and supportive care.
Recent research has highlighted the correlation between the imbalance of the microbiome and neurodegenerative diseases. Gut microbiota and brain cells can communicate bidirectionally to influence central nervous system physiology. Intestinal dysbiosis has been associated with various neurological disorders, including autism spectrum disorders, multiple sclerosis, Parkinson’s, and Alzheimer’s disease.
BIOM Pharma formulated Bi104 as a microbiome-modifying biologic to diversity and modulate the microflora and metabolite profile to reduce neuroinflammation in AS patients. Preclinical studies have shown significant benefits in improving seizures and behavioral aspects in a proven AS mouse model.
“There is no doubt that we need innovative new approaches for these difficult-to-treat epilepsies; traditionally, these indications were overlooked and were underfunded, but a new wave of innovative drug development is in progress with gene therapy and siRNA-based technologies. I think modulating the gut microbiome is another novel treatment approach. In this regard, we are excited to get the orphan designation for Bi104, which will be a key catalyst for our effort to develop the clinical pathway for Bi104,” said Dr. Bobban Subhadra, Co-Founder & President of BIOM Pharmaceutical Corporation.
“Procuring orphan designation for Bi104 is a major milestone for us and validates our technology and formulation to initiate a clinical program. This will also help us procure funding and strategic collaborations,” added Tom Gardner, Chairman of BIOM Pharmaceutical Corporation.
BIOM is committed to advancing Bi104 through clinical development and regulatory approval processes to bring hope and relief to patients and families affected by Angelman Syndrome.
For more information about BIOM Pharmaceutical Corporation and its groundbreaking work in rare disease therapeutics, please visit https://www.biompharma.com/.
About BIOM Pharmaceutical Corporation:
Biom Pharmaceutical is committed to the lofty goal of adding healthy years to the human lifespan by regulating the human microbiome through probiotics. This mission is at the heart of everything at Biom, from early research to product development. Biom Pharmaceutical is a pioneer in microbiome technology with five issued US Patents and has developed LiveBiom® Fermentation Technology to create humanized designer microbiome that has wide applications in human health and disease including immune regulation, cardiometabolic health, and neurodegeneration. Biom has developed True-To-Label nutritional supplements and has four consumer brands with twenty-three products in the market; Biom Probiotics® Total Gut Health products, VagiBiom® Feminine Care Products; Longiva® Antiaging and Longevity products, and LeanBiom® metabolic weight maintenance products.
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