A Live Biotherapeutic product is a biologic drug that contains live organisms, such as bacteria, and also is applicable to the prevention, treatment or cure of a disease or condition of human beings. Live Biotherapeutics are intended for FDA review and approval as biologic drugs.
Live Biotherapeautic Research Pipeline
Pre-Clinical
Phase 1
Phase 2
Phase 3
FDA Submission
PROF Study – Live Biotherapeutic to Reduce High Bowel Movement Frequency Patients with Ileal Pouch Anal Anastomosis (IPAA)
Check
Check
Check
PROTECT Study – Treatment of Anal High-Grade Squamous Intraepithelial Lesions (HSIL) in Persons with HIV (PWH)
Check
Check
Check