Soligenix’s SGX945 Gains UK PIM Designation, Shows 40% Improvement Over Apremilast
Soligenix’s SGX945 (dusquetide) earned Promising Innovative Medicine designation in the UK for Behçet’s Disease, unlocking potential entry into the Early Access to Medicines Scheme. In a Phase 2a pilot, SGX945 achieved a 40% AUC reduction in oral ulcers by Week 4 versus placebo, outperforming apremilast’s 37%.
1. PIM Designation in UK
SGX945 (dusquetide) secured Promising Innovative Medicine designation from the UK Medicines and Healthcare Products Regulatory Agency for Behçet’s Disease, qualifying it for the Early Access to Medicines Scheme. This designation recognizes SGX945’s potential to address a life-threatening, high-unmet-need condition and paves the way for earlier patient access.
2. Phase 2a Efficacy Results
In an open-label Phase 2a pilot, SGX945 showed a 40% improvement in the AUC of mean oral ulcer count versus placebo by Week 4, compared with a 37% improvement observed in the Phase 3 apremilast study. Improvement with SGX945 was sustained at 32% at Week 8 despite treatment cessation at Week 4, while apremilast recorded 41% at Week 8 under continuous dosing.
3. Safety and Tolerability Profile
SGX945 displayed a clean safety profile with no treatment-related adverse events reported in the Phase 2a study. This contrasts with apremilast’s common side effects—diarrhea (41%), nausea (19%) and headache (14%)—none of which were observed with SGX945.
4. Next Development Milestones
Soligenix will collaborate with the MHRA to advance SGX945 through the Early Access to Medicines Scheme and prepare for pivotal trials. The company aims to leverage the PIM designation to accelerate patient access and support regulatory submissions in the UK and potentially other regions.