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Palatin Technologies begins patient dosing in phase 1 study of PL-8177 for ulcerative colitis treatment

Cranbury, New Jersey
Wednesday, February 7, 2018, 13:00 Hrs  [IST]

Palatin Technologies, a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, announced that the first healthy subjects have been dosed in a phase 1 clinical study of PL-8177. The phase 1 study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study intended to evaluate the safety and tolerability of PL-8177 administered via subcutaneous injection. The study is designed to enroll up to 52 healthy volunteers.  Top line data is currently expected in the third quarter of 2018.

PL-8177, a selective melanocortin receptor 1 (MC1r) agonist peptide, is Palatin's lead clinical development candidate for ulcerative colitis and other inflammatory bowel diseases. Evolving research suggests that the MC1r system plays an important role in immunoregulation, including resolution of innate pro-inflammatory immune responses.

"This is a significant milestone for Palatin, as this is our second melanocortin peptide to enter clinical development," said Stephen T. Wills, chief financial officer and chief operating officer of Palatin Technologies.  "Beyond bremelanotide, for which we expect to file an NDA with the FDA for female sexual dysfunction later this quarter, we continue to expand our pipeline of novel peptide therapeutics targeting the melanocortin system. We are excited about the potential of our MC1r peptides, which have the potential to treat a wide variety of inflammatory diseases.  We currently anticipate additional compounds entering clinical development later this year."

PL-8177 is a synthetic cyclic heptapeptide with demonstrated efficacy in animal inflammatory bowel disease models.  Palatin has developed an oral formulation of PL-8177 that has been validated in animal studies, which is scheduled to be explored in future clinical investigations.  PL-8177 is a potent agonist at human MC1r, with sub-nanomolar affinity binding and EC50 functional values.


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