Soligenix’s SGX945 Granted UK Promising Innovative Medicine Designation for Behcet’s Disease

Soligenix announced that its investigational therapy SGX945 (dusquetide) has received Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of Behçet’s Disease. The designation is based on Phase 2 clinical data and represents the first step toward potential inclusion in the UK Early Access to Medicines Scheme (EAMS), which enables patients with serious or life-threatening conditions to access promising therapies before full regulatory approval.

Step Toward Early Patient Access

The PIM designation is granted to medicines that address significant unmet medical needs and demonstrate the potential to provide major advantages over existing treatments. It also requires evidence suggesting a favorable benefit-risk profile. For SGX945, the designation positions the therapy for possible entry into the UK’s Early Access to Medicines Scheme, potentially allowing patients with severe Behçet’s Disease to receive treatment sooner than under standard approval timelines.

Advancing Dusquetide in Rare Disease Treatment

SGX945 contains dusquetide, an innate defense regulator designed to modulate the body’s immune response and promote anti-inflammatory and tissue-healing effects. The drug candidate is being developed to treat aphthous ulcers associated with Behçet’s Disease, a chronic inflammatory disorder affecting blood vessels and causing painful lesions and systemic complications. The therapy builds on Soligenix’s broader pipeline targeting rare diseases and conditions with limited treatment options.