Wolfgang Brysch, President of Managing Board, MetrioPharm AG:
Dear shareholders and friends of MetrioPharm
These are exciting times for our company. In the spring of 2015, we have finally been able to commence clinical trials with our lead drug MP1032. This was a decisive milestone towards which the team has worked unswervingly since the founding of MetrioPharm. We all are thrilled by the excellent interim results from our Phase I study and the momentum this gives our entire development program. This momentum is picking up speed as we are getting ready for our Phase II with MP1032. All our development programs are running on schedule and we are looking forward to more good news in the coming months.
With best regards
President of Managing Board
Second part of Phase I Safety Study cleared by authorities
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 singledose 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. Copyright © 2015 MetrioPharm AG, All rights reserved.