We are advancing multiple monoclonal microbial product candidates into clinical studies across oncology and inflammatory diseases. We dosed the first subject in our clinical trial of our first candidate in our inflammatory diseases, EDP1066. First-in-human studies of our additional lead product candidates are expected to begin in 2018 and to deliver 10 clinical readouts across inflammatory diseases and cancer throughout 2019 and 2020.
|Indication||Product candidate||Preclinical development||Phase 1||Phase 2||Phase 3||First subject first dose (expected)||Initial clinical readout (expected)|
|Inflammatory Diseases||Psoriasis||EDP1066*||Initiated||1H 2019|
|EDP1815*||Q4 2018||2H 2019|
|Atopic Dermatitis||EDP1066*||Initiated||1H 2019|
|EDP1815*||Q4 2018||2H 2019|
|Rheumatoid Arthritis||EDP1815||1H 2019||1H 2020|
|Ulcerative Colitis / Crohn's Colitis||EDP1066||1H 2019||1H 2020|
|Oncology||Colorectal Cancer||EDP1503||1H 2019||1H 2020|
|Renal Cell Carcinoma||EDP1503||1H 2019||1H 2020|
|PD-1 Relapsed||EDP1503||1H 2019||1H 2020|
|Melanoma#||EDP1503||2H 2018||2H 2020|
|* UK Study
# US Investigator-sponsored study
Inflammatory Disease Portfolio
We are advancing two monoclonal microbials, EDP1066 and EDP1815, into the clinic for the treatment of inflammatory diseases. Several other potential product candidates have been identified in our discovery program.
EDP1066 is a monoclonal microbial product candidate being developed to treat inflammatory diseases. We dosed the first subject in our clinical trial of EDP1066 in clinical trial EDP1066-001.
About Clinical Trial EDP1066-001
EDP1066-001 is a dose-escalating safety and tolerability clinical study of EDP1066 in 36 healthy volunteers and in 60 patients with psoriasis or atopic dermatitis. It will test a range of daily doses in healthy volunteers over 14 days and in patients over 28 days. We will evaluate safety as a primary endpoint, as well as a variety of pharmacodynamic markers, including biomarker signals from paired biopsies of affected skin in patients, as secondary endpoints. We dosed the first subject in April 2018.
EDP1815 is our second monoclonal microbial product candidate that is being developed to treat inflammatory diseases. In preclinical testing, EDP1815 has exhibited a different set of biological activities than EDP1066. In preclinical studies, EDP1815 showed immunomodulatory activity on human immune cells and anti-inflammatory activity in many discrete tissues, including skin, joints, gut and the central nervous system. We expect to initiate a clinical trial for EDP1815 in the fourth quarter of 2018. We expect initial biomarker and clinical data from this trial in the second half of 2019.
We are developing monoclonal microbials intended for the treatment of cancer. We are actively evaluating and expect to select additional oncology clinical candidates through our discovery program.
EDP1503 is our first monoclonal microbial product candidate that is being developed to treat cancer. We selected EDP1503 based on its observed in vitro profile in human immune cell assays, as well as its anti-tumor activity in a range of preclinical mouse tumor models. We expect to initiate clinical testing for EDP1503 in the second half of 2018. We expect to obtain clinical response data in the second half of 2020.
Potential Next Wave
Beyond our first set of clinical product candidates, we have identified several other potential candidates from our discovery program, and we are continuing to invest in the discovery of additional potential candidates. We believe monoclonal microbials and our platform have broad potential utility beyond our initial therapeutic focus areas of inflammatory diseases and oncology, and we plan to pursue many opportunities in which our platform has the potential to transform medicine.
Our goal is to create and develop a new class of therapies that have the potential to transform the treatment of a broad range of diseases by focusing on the gut-body network. Key elements of our strategy to achieve this goal are to:
- Realize the full potential of the gut-body network to create an expansive and diversified product portfolio;
- Develop best-in-class therapies to improve outcomes across various stages of disease;
- Generate early clinical readouts with biomarker driven validation to efficiently advance our product candidates;
- Industrialize monoclonal microbials to advance and scale our platform;
- Strengthen and expand our intellectual property to protect our platform; and
- Collaborate to realize the potential of the gut-body network and monoclonal microbials.