UK Grants Innovation Passport to Solid Biosciences’ AAV Gene Therapy SGT-003 for Duchenne Muscular Dystrophy

CHARLESTOWN, Mass. and LONDON, UK — Nov. 6, 2025 — Solid Biosciences Inc. (Nasdaq: SLDB) today announced that SGT-003, its investigational AAV gene therapy for Duchenne muscular dystrophy (Duchenne), has been granted an Innovation Passport under the United Kingdom’s new Innovative Licensing and Access Pathway (ILAP).

The Innovation Passport serves as the entry point for the ILAP, a program designed to accelerate time to market and expedite patient access to transformative new medicines in the UK. This designation allows Solid to work directly with the UK Medicines and Healthcare products Regulatory Agency (MHRA), the National Health Service (NHS), and health technology assessment bodies (NICE, SMC, and AWTTC) to develop a product-specific roadmap for accelerated regulatory and development milestones.

SGT-003 is among the first investigational medicinal products to join the relaunched ILAP, which targets transformative products addressing high unmet clinical needs. This designation supports the potential for SGT-003 to become the first-to-market gene therapy in the UK for Duchenne.

Enhanced Collaboration for Accelerated Access

Jessie Hanrahan, Ph.D., Chief Regulatory & Preclinical Operations Officer of Solid Biosciences, emphasized the designation’s impact: “Receiving the Innovation Passport designation is further recognition of SGT-003’s potential to transform the treatment paradigm for those living with Duchenne. We are thrilled to have received this designation, which provides early and enhanced interactions with regulators and access to development tools designed to enable accelerated regulatory timelines.”

SGT-003 is an AAV gene therapy that utilizes a proprietary, next-generation capsid, AAV-SLB101, designed to target integrin receptors for enhanced cardiac and skeletal muscle transduction. It includes a differentiated microdystrophin construct that uniquely contains the R16/17 domain, which can potentially improve muscle health by reducing muscle breakdown and fatigue.

Community Support and Clinical Progress

The news was welcomed by patient advocacy groups. Emily Reuben, Co-founder and CEO of Duchenne UK, stated, “We hope the new ILAP will deliver on its aim of streamlining and speeding up the development and access for SGT-003, and ultimately, if the data support it, deliver access to a promising new treatment for patients in the National Health Service (NHS).”

SGT-003 is currently being evaluated in the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trial, which is enrolling participants across the US, UK, Italy, and Canada. Additionally, Solid has begun screening participants for IMPACT DUCHENNE, a Phase 3, randomized, double-blind, placebo-controlled trial designed to support potential ex-U.S. regulatory authorizations.