Preparations for New Studies

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A report on the current projects of the MetrioPharm team

Photo: © Sandra Meissner

Timetables on the office walls, e-mails with long to-do lists and meetings of all project groups: The new year has started off busy. In order to move the MetrioPharm pipeline ahead as planned, the team is coordinating several major projects simultaneously.

One of the most important is the completion of the Phase II trial in the indication psoriasis. The last patients are currently being included in the trial centers so that recruitment can be completed by the end of February. While the treatment phase of the patients is still ongoing, we are preparing the review and evaluation of the data so that we can publish the results of the study – as planned – in the course of 2019.

At the same time, we are working on a clinical trial in a second indication. The design of the study has already been finalized. We are now using this design (or study synopsis) to find the right partner to conduct the study. In this second study we will test MP1032 in the field of musculoskeletal diseases, so we want to work with a CRO (Clinical Research Organization) that has many years of experience in this field.

We will analyze the offers of these contract research institutes according to a well-established multi-stage system. Once the ideal partner has been found, we will jointly work out all the necessary study materials, from the study plan to the patient information.

Simultaneously, practical preparations must be made. MetrioPharm will need a total of 150,000 capsules of MP1032 for the patients in this study. Not a small quantity, but still not enough to order a fully automated production. The drugs will be handmade by specialized manufacturers. This complex process must be approved by the authorities at an early stage and planned in advance.

And another project is on the way, strictly speaking even two. In order to be able to test MP1032 in a clinical phase III in the future – that is, over a treatment period of several months – so-called preclinical long-term toxicology studies must first be carried out. Our team has developed two such preclinical studies, and they will begin at the end of February or beginning of March respectively. Thus, we are already paving the way for the next stage of clinical development.

So what will the coming months look like for MetrioPharm? There will certainly be more meetings and more e-mails with to-do lists. If all goes well, we will also be able to set many checkmarks on the timetables on our office walls. The first ones we made already.