Biom Therapeutics is planning for FDA
Phase 3 – Human Clinical trial for Angelman Syndrome using cannabinoid to target multiple pathologies of DEE
DEEs are a heterogeneous group of rare and ultra-rare epilepsy syndromes that manifest with seizures, behavioral disturbances, or EEG abnormalities that can directly worsen cognition and behavior. These disorders are often progressive and are highly resistant to treatment.
Per CDC, in 2015 1.2% of the total US population had active epilepsy. This is about 3.4 million people with epilepsy nationwide: 3 million adults and 470,000 children. 50% are genetic or rare diseases.
No drugs have looked specifically addressed behavioral and development co-morbidities. BIOM Therapeutics have developed BIOM017a as a treatment for Developmental & Epileptic Encephalopathies (DEE). Preclinical and early clinical studies reflects promising results.
DEE has a market share value of $3 Billion by 2030 with a total patient population of 115,000
Biom has completed preclinical studies on the safety and efficacy of BIO017 in Angelman Syndrome mouse model.
We have gathered pharmaceutical industry leaders, clinicians, regulatory and research specialists to work collaboratively with the FDA to run a phase-3 clinical studies for Angelman Syndrome using BIO017
BIOM Therapeutics is one of only a few companies in the world developing products using cannabinoids to target pathologies of rare disease genetic epilepsy. Market Opportunity of $370 million / year in sales.