EXE-346 Live Biotherapeutic – A “Food To Drug” Conversion
Time: 1:30 pm
day: Day One Track A (PM)
Details:
- EXE-346 is a high dose probiotic blend intended for the treatment of excessive stool frequency in patients with an ileal pouch anal anastomosis
- The same formulation in a lower potency has been commercialized as a non-drug product for over 20 years under several consumer brand names
- The presentation will summarize the evolution of this product from “food to drug” and explore the benefits and pitfalls of pursing a drug approval strategy with historically nondrug probiotics
