Proof-of-Concept & Clinical Studies

This innovation area focuses on the development and implementation of innovative diagnostic and therapeutic studies, especially in the field of immuno-mediated inflammatory and pain diseases. In addition to the development, implementation, organisation and project management, the core expertise consists in the evaluation and interpretation of clinical research projects as an interface with the institute's own expertise in the field of medicine, data management and statistics. The established project management structure enables quality-controlled clinical studies to be carried out as an independent research organisation within the framework of investigator-initiated studies with the takeover of sponsorship by the Fraunhofer-Gesellschaft and/or to realize quality-assured and legally compliant study projects together with academic and industrial partners.

Core competencies:

Design of clinical trials with use of medical expertise and by use of innovative endpoints according to “quality by design”
Definition of and access to suitable study populations with a focus on immune diseases and pain through close networking with the Frankfurt University Hospital and associated study centers
Conduct of clinical studies according to German drug medical device laws and other clinical studies
Conduct Proof-of-Concept studies
Project management established for conduct of Investigator Initiated Trials (IIT) under sponsorship of Fraunhofer-Gesellschaft or support of external Sponsors in the indication of immunmediated diseases
Study coordination and monitoring fo mono- and multicentric, national and international clinical trials
Interface to preclinical department, data management, statistics and medical writing
Infrastructure for performance of “First in Man” clinical trials

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The innovation area "Proof of concept I Clinical Studies" offers the optimal infrastructure for the conception and implementation of clinical studies in all clinical phases as well as the proof of concept in the main indication fields of immune mediated diseases and pain for industrial and academic partners. A qualified interdisciplinary team consisting of doctors, scientists, data managers and statisticians accompanies a project from the project idea to the full implementation according to the current regulations, such as local and European laws and guidelines, to the final evaluation. Due to an established quality management system and the direct interfaces to the preclinical and analytical departments, all necessary resources are available to bring substance development from the preclinical to the clinical proof-of-concept. In particular, through the establishment of a process for the assumption of sponsorship (according to AMG / GCP) by the Fraunhofer-Gesellschaft, there is a great deal of expertise in the implementation of investigator-initiated trials (IIT) in cooperation with academies and industrial partners from pharmaceuticals and smaller biotech companies. In addition, the infrastructure for conducting clinical studies of early drug development is provided by the own phase 1 units.

Design and preparation of clinical trials at the interface of medicine by use of innovative endpoints
Access to suitable patient populations in the indication fields immune diseases and pain
Project management according to regulatory requirements and laws based on an established quality management system
Investigator Initiated Trials (IIT) with takeover of sponsorship by Fraunhofer-Gesellschaft
Study coordination, including contract management, submission to ethical committee and competent authority, site coordination, budget administration
Monitoring to ensure patient safety, compliance with laws and regulations and data validity
Coordination of preclinic, analytics, data management, statistic and medical writing, preclinic, preclincal, data management, statistics and medical writing for external partners
Phase 1 Unit for the implementation of clinical studies of early medical drug development including trained medical staff and optimal infrastructure

Selected Projects

AcceleRAte

Controlled, open, parallel group, multinational, multicentric phase IV study in the indication of active rheumatoid arthritis to demonstrate the superiority of therapy using a JAK inhibitor (compared to a TNF alpha-inhibiting therapy) in the proportion of patients who experience early pain reduction (as measured by the proportion of patients who can stop controlled celecoxib treatment at week 12 and who experience clinically relevant pain relief).

PrevTel

Proof-of-Concept study to evaluate the efficacy and safety of the drug candidate TMP002 for the prevention of chemotherapy-induced neuropathic pain in the high-risk population.

Partners: Helmholtz and university medicine Frankfurt within the framework of the Proof-of-Concept Initiative

This study is part of the Proof-of-Concept Initiative

PANORA

Clinical study project in cooperation with the Institute for General Practice to improve the early rheumatological work-up of patients with positive detection of antiCCP antibodies in the rapid test and newly emerged unspecific musculoskeletal complaints via the general practitioner.

Partner: Institute for General Practice, Goethe University Frankfurt

Selected Publications

Behrens F, Tak PP, Østergaard M, Stoilov R, Wiland P, Huizinga TW, Berenfus VY, Vladeva S, Rech J, Rubbert-Roth A, Korkosz M, Rekalov D, Zupanets IA, Ejbjerg BJ, Geiseler J, Fresenius J, Korolkiewicz RP, Schottelius AJ, Burkhardt H.
MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial.
Ann Rheum Dis. 2015 Jun;74(6):1058-64
doi: 10.1136/annrheumdis-2013-204816

Schmiedl S, Peters D, Schmalz O, Mielke A, Rossmanith T, Diop S, Piefke M, Thürmann P, Schmidtko A.
Loxapine for Treatment of Patients With Refractory, Chemotherapy-Induced Neuropathic Pain: A Prematurely Terminated Pilot Study Showing Efficacy But Limited Tolerability.
Front Pharmacol. 2019 Jul 25;10:83
doi: 10.3389/fphar.2019.00838

Kaltwasser JP, Nash P, Gladman D, Rosen CF, Behrens F, Jones P, Wollenhaupt J, Falk FG, Mease P.
Treatment of Psoriatic Arthritis Study Group. Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and psoriasis: a multinational, double-blind, randomized, placebo-controlled clinical trial.
Arthritis Rheum. 2004 Jun;50(6):1939-50

doi: 10.1002/art.20253

Behrens F, Koehm M, Arndt U, Wittig BM, Greger G, Thaçi D, Scharbatke E, Tony HP, Burkhardt H.
Does Concomitant Methotrexate with Adalimumab Influence Treatment Outcomes in Patients with Psoriatic Arthritis? Data from a Large Observational Study.
J Rheumatol. 2016 Mar;43(3):632-9
doi 10.3899/jrheum.141596

Nothnagel L, Jung F, Rossmanith T, Thurn M, Ashtikar M, Geisslinger G, Parnham MJ, Wacker MG.
Predictive PBPK modeling as a tool in the formulation of the drug candidate TMP-001.
Eur J Pharm Biopharm. 2019 Jan;134:144-152
doi: 10.1016/j.ejpb.2018.11.012