FDA Grants Orphan Drug Designation to Biompharma’s Bi104, a microbiome-modifying biologic, for the treatment of Angelman Syndrome
2024年5月8日 - 10:25PM
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, vaginal 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.
- Biom Pharmaceutical Corporation
Mark Kaley
Biom Pharmaceutical Corporation
(407) 394-5881
mark.kaley@otterpr.com