Drug intelligence / Profile preview

FZ002

Development stage
Phase 1
Lead developer
FZata
Modality
Live Biotherapeutic Products → Microbiome Therapeutics, Small Molecules
Administration
Oral
01

Overview

FZ002 refers to two distinct investigational drugs in current development: 1. **FZ002 by Fzata** is a first-in-class live biotherapeutic yeast genetically engineered to express a tetraspecific anti-toxin for *Clostridioides difficile* (C. difficile) infection. It is designed for oral delivery and acts directly in the gastrointestinal tract, neutralizing both C. difficile toxins A and B while providing probiotic activity without promoting antibiotic resistance. The drug leverages Fzata’s Bioengineered Probiotic Yeast Medicines (BioPYM) platform, functioning as a “micro-factory” that produces therapeutic biologics *in situ* within the GI tract[1][4][7]. Its primary indication is prevention and treatment of recurrent C. difficile infection. 2. **FZ 002 / FZ002-037 by Guangzhou Fermion Technology** is an orally administered small-molecule non-opioid analgesic developed for pain management, particularly targeting somatostatin receptor subtype 4 (SSTR4). This highly selective SSTR4 agonist primarily acts on peripheral pain pathways to provide analgesia without central nervous system side effects or addiction potential[3][5]. It has completed Phase I trials in China with plans for Phase II studies targeting diabetic peripheral neuropathic pain and potentially other chronic or acute pain conditions.

02

Targets

TcdA (Clostridioides difficile toxin A)TcdB (Clostridioides difficile large clostridial toxin family)SSTR4 (Somatostatin receptor 4)

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