EMA agrees to Soligenix’s Pediatric Investigation Plan for SGX942

Soligenix announced that the Pediatric Committee, or PDCO, of the European Medicines Agency, or EMA, agreed to the Company’s Pediatric Investigation Plan, or PIP, for SGX942, or dusquetide. It was also agreed that the Company may defer conducting the PIP until successful completion of its ongoing pivotal Phase 3 clinical study evaluating SGX942 as a treatment for oral mucositis in patients with head and neck cancer, or HNC. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. Soligenix will be able to file the adult indication MAA prior to completion of the PIP because the PDCO permitted the Company to defer conducting the pediatric program until the benefit/risk of treatment has been established in the adult population. Following a potential approval of the SGX942 MAA for treatment of oral mucositis in adult patients with HNC, Soligenix will work with PDCO and EMA to include appropriate pediatric data in the approved labeling.

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