Pipeline

PTH

Topical PTH (1-34) for Psoriasis

PTH (1-34) is an agonist that mimics a natural protein responsible for regulating the growth of skin cells. This natural protein, PTHrp, is significantly reduced in the skin of psoriasis patients, leading to skin cell hyperproliferation, poor differentiation of skin cells, and ultimately, the accumulation of dry thick patches of skin (plaques). Acting in place of the absent PTHrp, it is believed that PTH (1-34) is able to restore skin cells’ normal rate of development, migration and turnover, reducing cell accumulation and the formation of plaques. While the product’s active ingredient is incorporated into currently approved therapeutics, Manhattan Pharmaceuticals has developed and is advancing a new, proprietary topical gel formulation of PTH (1-34) for the treatment of psoriasis.

A corporate investigational new drug (IND) application for the improved formulation of topical PTH (1-34) was accepted by the U.S. Food and Drug Administration in September 2007. In October 2007, the company initiated and began dosing in a Phase 2a multi-center, randomized, double-blind, vehicle-controlled, parallel group clinical study. This study will enroll and treat approximately 54 subjects in a 1:1:1 randomization of two doses of topical PTH (1-34) compared to vehicle for an eight week treatment period. The vehicle is the topical PTH (1-34) product without the active ingredient, PTH (1-34).

In a previously completed Phase 1/2, double-blind, placebo-controlled study, conducted under a physician IND at Boston University Medical Center, topical PTH (1-34) demonstrated a greater than 67% global improvement in the trial’s psoriasis patients. Approximately 60% of the patients experienced a complete clearing of their lesions, with 85% experiencing at least partial clearing. Additionally, topical PTH (1-34) treatment was well tolerated with no adverse effects reported.