PL8177 for COVID-19
Agonism of the melanocortin-1 receptor (MC1r) has been demonstrated in animal models to protect against lung fibrosis under profibrotic conditions, provide organ protection in response to pro-inflammatory cytokine levels and other challenges, and reduce levels of pro-inflammatory cytokines (interleukin [IL]-1, IL-2, IL-4, IL-6, IL-13, tumor necrosis factor alpha [TNF-α], type II interferon [IFN-γ]). While agonism of other melanocortin receptors, principally melanocortin-3 receptor (MC3r) and melanocortin-5 receptor (MC5r), may provide some beneficial effects in inflammation resolution, benefit appears to result primarily from MC1r agonism. It is hypothesized that an MC1r agonist may be of utility in treating COVID-19 patients with cytokine storm, acute respiratory distress syndrome (ARDS) and lung fibrosis.
PL8177 is a selective MC1r agonist that has been evaluated in multiple preclinical inflammatory disease models. In an established preclinical disease model of lung fibrosis (bleomycin model) PL8177 was able to block initiation of lung fibrosis and protect against lung damage. PL8177’s effects on resolving inflammation and lung fibrosis indicate that PL8177 may have potential as a treatment for COVID-19 patients.
Palatin has had discussions with BARDA and has received feedback from the FDA on a submitted pre-IND briefing package. We are currently preparing to initiate a phase 2 study in COVID-19 patients. The phase 2 study will use an adaptive design to limit risk and is targeted to enroll up to 176 hospitalized subjects. The environment for conducting COVID-19 studies is rapidly evolving and the initiation of the PL8177 phase 2 study is potentially dependent on access to third party funding and clinical trial resources, and the status of COVID-19 vaccine and therapeutic developments.