JJP Biologics announces that the European Commission Has Designated JJP-1212 as an Orphan Medicinal Product

JJP-1212, a first-in-class CD89 antagonist is being developed for the treatment of the rare autoimmune skin blistering disease linear IgA bullous dermatosis in addition to other IgA-mediated autoimmune and inflammatory diseases

October 20, 2022

Warszawa, Polska – JJP Biologics, a private company that specializes in the development of proprietary biologic agents for personalized medicine approaches, has announced that the European Commission has approved the company’s application for designation of its product candidate JJP-1212 as an orphan medicinal product for treatment of Linear IgA Bullous Dermatosis (LABD). 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.
“The orphan drug designation of JJP-1212 by the EMA validates the scientific and business choices of JJP Biologics. It was confirmed that JJP-1212 targets the central mechanism in LABD by antagonizing the IgA-CD89 interaction” according to Louis Boon, the Chief Scientific Officer at JJP Biologics. “We are very excited to offer a potential novel therapy for patients suffering from this ultra-rare skin disease with currently unmet needs”.
Having this drug classified into the group of orphan medicinal products provides scientific advice and protocol assistance of the agency. “This decision by the European Commission has also a substantial streamlining effect on the clinical development timeline. We feel the responsibility to translate this decision into prompt availability of the therapy for patients” states Paweł Szczepański, the Chief Oper Operating Officer at JJP Biologics.
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.
Informacja o firmie:
JJP Biologics sp. z o.o. is a pre-clinical-stage biotechnology company that specializes in the development of therapeutic monoclonal antibodies accompanied by companion diagnostics for personalized treatment. 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 for autoimmunity and an JJP-1008 program for immune-oncology. For more information visit www.jjpbiologics.com i dołącz do społeczności #smartgoose, obserwując nas na LinkedIn
W przypadku pytań, prosimy o kontakt:

Pobierz jako plik PDF >>