Therapy Areas: Autoimmune
The European Commission Designates JJP-1212 as an Orphan Medicinal Product
20 October 2022 - - The European Commission has approved Poland-based biotechnology company JJP Biologics' application for designation of its product candidate JJP-1212 as an orphan medicinal product for treatment of Linear IgA Bullous Dermatosis, the company said.

JJP Biologics is a company that specializes in the development of proprietary biologic agents for personalized medicine approaches.

Following the European Medicines Agency's recommendation, the European Commission has confirmed that the intention to treat this condition with JJP-1212 justified orphan drug status based on in vitro and in vivo non-clinical data showing the reduction in the influx of granulocytes into the basement membrane zone of the skin and reduction of inflammatory biomarkers, addressing the key elements of LABD skin blistering pathogenesis.

LABD is a chronically debilitating disease and may lead to blindness and blister formation. Moreover, currently no approved treatments are available for LABD in the European Union.

The European Commission has confirmed that, as of the day of submitting the application, LABD could affect approximately 0.3 in 10,000 persons in the European Union.

Having this drug classified into the group of orphan medicinal products provides scientific advice and protocol assistance of the agency.

JJP Biologics sp. z o.o. is a biotechnology company that specializes in the development of proprietary biologic agents accompanied by companion diagnostics to allow therapy personalization.

JJP Biologics is a privately funded biotech which pursues the development of its own product candidates as well as projects executed in cooperation with scientific partners.

The company's programs target general immune pathways that have application in autoimmune diseases and cancer. JJP Biologics currently has a range of programs including the most advanced JJP-1212 program and an anti-CD270 program for immune oncology.