Membership Directory - Corporate
Fzata, Inc.
About
Fzata’s vision is to be the world leader in oral biologics. We have captured the “holy grail” of oral biologics with our first-in-class live Bioengineered Probiotic Yeast Medicines (BioPYMTM) Platform. Our mission is to expand patient safety, efficacy & access to biologics with BioPYM. NIH has vetted and validated BioPYM; designating Fzata as an NIH Seed Company.
The proprietary oral BioPYM platform acts as a micro-factory in the gut making therapeutic locally at the disease site. BioPYM naturally exits the body with waste in about 3 days. BioPYM’s genomic cassette allows easy insertion of any gene to make any protein therapeutic including monoclonal antibodies, enzymes, cytokines, and hormones. The BioPYM international patent portfolio is owned by Fzata.
BioPYM competitive advantages compared to conventional parenteral injectables include 1) Improved Patient QoL: better outcomes, no needles, no clinic infusions 2) Clinical benefits: no trough/peaks in drug level, no side-effects from systemic distribution, OK to use with antibiotics, no anti-drug antibody response, no concomitant immunosuppressant, microbiota support, 3) Manufacturing: low cost of goods, no cold-chain, cross-over manufacturing efficiencies, scalable, plug and play platform.
Fzata has a deep GI pipeline. The drug candidates all show high safety, superiority to standard of care, and efficacy in respective animal models for gastrointestinal-related infectious diseases including, inflammatory bowel disease (IBD), C. diff infection, diabetes and abdominal pain.
Our lead product, FZ002 for C. diff infection, is on schedule for an NIH supported first-in-human trial in 2024. Successful readout will prove the safety of BioPYM and derisk CMC for other BioPYM candidates.
FZ006 for IBD has demonstrated efficacy in 2 humanized mouse models. Pig PK is completed. FZ006 will be the first oral anti-TNF for ulcerative colitis and Crohn’s Disease in moderate to severe populations. In addition, it will be the first to market anti-TNF for mild populations. US TAM for FZ006 >$6B.
We are raising a $10M seed round to support FZ006 for IBD manufacturing and IND filing as well as additional pipeline activities and G&A. For inquiries please contact Elizabeth_Smith@fzata.com
The proprietary oral BioPYM platform acts as a micro-factory in the gut making therapeutic locally at the disease site. BioPYM naturally exits the body with waste in about 3 days. BioPYM’s genomic cassette allows easy insertion of any gene to make any protein therapeutic including monoclonal antibodies, enzymes, cytokines, and hormones. The BioPYM international patent portfolio is owned by Fzata.
BioPYM competitive advantages compared to conventional parenteral injectables include 1) Improved Patient QoL: better outcomes, no needles, no clinic infusions 2) Clinical benefits: no trough/peaks in drug level, no side-effects from systemic distribution, OK to use with antibiotics, no anti-drug antibody response, no concomitant immunosuppressant, microbiota support, 3) Manufacturing: low cost of goods, no cold-chain, cross-over manufacturing efficiencies, scalable, plug and play platform.
Fzata has a deep GI pipeline. The drug candidates all show high safety, superiority to standard of care, and efficacy in respective animal models for gastrointestinal-related infectious diseases including, inflammatory bowel disease (IBD), C. diff infection, diabetes and abdominal pain.
Our lead product, FZ002 for C. diff infection, is on schedule for an NIH supported first-in-human trial in 2024. Successful readout will prove the safety of BioPYM and derisk CMC for other BioPYM candidates.
FZ006 for IBD has demonstrated efficacy in 2 humanized mouse models. Pig PK is completed. FZ006 will be the first oral anti-TNF for ulcerative colitis and Crohn’s Disease in moderate to severe populations. In addition, it will be the first to market anti-TNF for mild populations. US TAM for FZ006 >$6B.
We are raising a $10M seed round to support FZ006 for IBD manufacturing and IND filing as well as additional pipeline activities and G&A. For inquiries please contact Elizabeth_Smith@fzata.com
