Many ocular diseases are characterized by chronic inflammation. Current therapies
generally target the symptoms but not the underlying cause. We believe that
melanocortin receptor 1 (MC1r) peptides we are developing have broad anti-
inflammatory effects and appear to utilize mechanisms engaged by the
endogenous melanocortin system in regulation of the immune system and
resolution of inflammatory responses. We are also developing peptides that are
active at more than one melanocortin receptor.
PL9643 for Dry Eye Disease
PL9643, a peptide melanocortin receptor agonist which is active at multiple
receptors, is our lead clinical development candidate for anti-inflammatory ocular
indications, including dry eye disease, which is also known as keratoconjunctivitis
sicca. Dry eye disease is a syndrome with symptoms including irritation, redness,
discharge and blurred vision. It may result from an autoimmune disease such
Sjögren’s syndrome, an ocular lipid or mucin deficiency, blink disorders, abnormal
corneal sensitivity or environmental factors.
We filed an Investigational New Drug (IND) application with the Food and Drug
Administration (FDA) in December 2019, and initiated Phase 2 human clinical trials
in February 2020.
The Phase 2 study is a multi-center, randomized double-masked and placebo-
controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution
(topical eye drops) compared to placebo for the treatment of the signs and
symptoms of dry eye. The study is designed to enroll up to 150 participants at three
sites in the US. Patients will be randomized in a 1:1 ratio into two arms, PL9643 or
placebo, and will undergo 12-weeks of treatment. The two primary endpoints are
inferior corneal fluorescein staining and ocular discomfort. We expect to report
data from this study as early as the fourth quarter of 2020.
Systemic PL8177 for Non-Infectious Uveitis
PL8177, a selective MC1r agonist peptide, has been granted orphan drug
designation by the FDA for the treatment of non-infectious intermediate, posterior,
pan and chronic anterior uveitis. Non-infectious uveitis is a group of inflammatory
diseases that produces swelling and destroys eye tissue and can result in vision loss.
A Phase 2 study in non-infectious uveitis using a systemic delivery formulation
of PL8177 is scheduled to start in the second half of calendar year 2020, with data
anticipated in late calendar year 2021.