We are conducting preclinical studies with our melanocortin receptor-1 (MC1r) peptide drug candidates for a number of indications, primarily inflammatory disease-related and autoimmune indications. The MC1r is upregulated in a number of diseases, including inflammatory bowel disease, nephritis (inflammation of the kidneys), rheumatoid arthritis, ocular indications such as uveitis and dry eye, and dermatologic indications. We believe that MC1r peptides have an anti-inflammatory effect and can work to regulate the immune system and resolve pro-inflammatory responses.
Our MC1r peptide drug candidates are highly specific, with substantially greater binding and efficacy at MC1r than at other melanocortin receptors. In vitro safety studies have shown that our MC1r peptide drug candidates have no activity in a wide range of various receptors, ion channels and kinases. Our MC1r peptide drug candidates typically have a half-life in animal models of greater than two hours.
Animal studies that we have conducted with our MC1r peptides have shown positive results in experimental models of inflammatory bowel disease, uveitis and nephritis. We are continuing to conduct studies on a number of different indications.
Our Lead Inflammatory Disease Product Candidate
Our lead inflammatory disease product candidate is a synthetic peptide we developed with the code name PL-8177.
We have completed preclinical toxicology testing on PL-8177 and chemistry, controls and manufacturing activities to support Phase 1 studies. We anticipate filing an IND application on PL-8177 as early as the second half of calendar 2017, followed by a first-in-man Phase 1 clinical trial for inflammatory bowel diseases.
PL-8177 has demonstrated efficacy in preclinical models for autoimmune uveitis, inflammatory bowel disease and nephritis. Preclinical animal studies show PL-8177 suppresses the physiologic activity of inflammatory challenges, resulting in the reduction of a number of inflammatory cytokines.
We have another synthetic peptide we developed, with the code name PL-8331, which is selective for both the melanocortin receptor-1 and melanocortin receptor-2. This peptide is under preclinical evaluation in ocular inflammatory models, and if results are acceptable, we will initiate preclinical activities to support Phase 1 studies in the second half of calendar 2017.