The staff of Dr. Falk Pharma's own Development Department have many years of experience in galenic, pre-clinical and clinical development. Almost all of our development projects are carried out in co-operation with other research enterprises. In galenics, Dr. Falk Pharma has special competence in the development of topical medicines for the intestinal tract, which has resulted in a large range of patents and approvals.
The project management team in clinical research is highly experienced in the organization of multi-center studies required for approval, especially for inflammatory bowel diseases and certain liver diseases. An international network of doctors has been established over many years, which allows even large multicenter studies to be carried out rapidly and successfully.
Close co-operation between the Development and Regulatory Affairs Departments forms the basis of the high quality of documentation needed to meet the requirements of the regulatory authorities today. Our own experience with the various European regulatory and approval procedures contribute to the success of our approval team.
The company co-operates with international partners for the majority of projects in new medicines and further developments. New project partners in gastroenterology and hepatology are always welcome.
At the forefront of current development activities are not only new substances for the treatment of inflammatory bowel diseases and other intestinal diseases or diseases of the liver, bile duct and the esophagus, but also further development of already approved preparations, for example in the form of new galenic preparations. New areas of application are also being sought for medications used today.
The medications are produced in co-operation with contract organizations. Pharmaceutical controls are then carried out within our company in accordance with national and international regulations.
Klinische Studie zur Beurteilung eines neuen, sich in der Erprobung befindlichen biologischen Medikaments. Der Name der Studie ist TRUST-2, was für „TRichUris Suis ova Trial“ steht.
Mehr als 200 Patienten mit MORBUS CROHN haben das sich in der Erprobung befindende Studienmedikament bisher in klinischen Studien eingenommen.
Die Studien zeigen eine Abnahme der Krankheitsaktivität und in der Mehrzahl der Fälle wurde Remission (beschwerdefreie Phase) erzielt. Die bisher beobachteten Nebenwirkungen betrafen zumeist den Verdauungstrakt.