Second part of Phase I Safety Study cleared by authorities
Berlin/Zurich, October 19, 2015. Following the completion of the single-dose segment in the MP1032 Phase I first-in-man study, the clinical and safety data from this trial were submitted by MetrioPharm to the German regulatory authority (BfArM) for a safety review.
Safety is the paramount concern during any first-in-man study and thus BfArM performs an interim review between the single-dose and multiple-dose segment of a Phase I study. Such a review allows the authorities to request additional safety precautions for subsequent study segments or even halt the study, should there be any safety concerns arising from the single-dose data.
Based on the fact that in the single-dose part of Phase I MP1032 had not shown any adverse reactions or tolerability issues, BfArM recently gave the go-ahead for the multiple-dose part of Phase I without any additional safety restrictions. The multiple-dose part will thus start in October 2015 and the entire Phase I study is expected to be completed on schedule before the end of the year.
Phase IIa Proof-of-concept trial in preparation
In parallel to the ongoing MP1032 Phase I trial, MetrioPharm has begun the preparation work for the Phase IIa proof-of-concept study in psoriasis. Like Phase I, MetrioPharm plans to conduct this study in Germany, as this allows for streamlined regulatory interaction and subsequent completion of the study. The primary aim of this study is to demonstrate therapeutic activity for MP1032 in a controlled clinical setting.
We picked psoriasis as the initial indication for two major reasons:
1. Psoriasis is considered a model disease for a whole range of other chronic inflammatory/autoimmune diseases. Also the signs and symptoms of the disease are visible on the skin without the need for any diagnostic or invasive intervention for the patients. Thus positive data in psoriasis would signal likely efficacy of MP1032 in a host of other indications.
2. Psoriasis in itself is a very attractive target market for MP1032. There is still a high medical need for an effective and highly safe oral drug to treat mild and moderate forms of psoriasis, which do not warrant the use of very expensive injectable biological drugs (antibodies).
This study will be submitted to the German authorities in January 2016, shortly after final Phase I data are available for inclusion into the application.
The proprietary drug candidate MP1032 is a synthetic small-molecule drug with strong anti-inflammatory properties and an excellent pre-clinical safety profile. MP1032 acts primarily through the modulation of macrophages, the main cells of the innate immune system. Macrophage modulators represent a new class of drugs that modulate inflammation with a very broad spectrum of potential clinical applications