Solid Biosciences announced that SGT-003, the Company’s investigational gene therapy for Duchenne muscular dystrophy (Duchenne), has been granted an Innovation Passport under the new ILAP. The Innovation Passport is the entry point for the ILAP, which aims to accelerate time to market and facilitate patient access to new medicines in the UK. The Innovation Passport activates the MHRA and the ILAP partner agencies to develop a product-specific roadmap for regulatory and development milestones.
SGT-003 is one of the first three investigational medicinal products joining the new ILAP, which focuses more selectively on transformative products that address unmet clinical needs. Read More: Frequently Asked Questions About Solid Biosciences SGT-003 Gene Therapy
What does innovation passport mean?
- Innovation Passport award facilitates accelerated time to market and helps expedite patient access to transformative new medicines.
- New Innovative Licensing and Access Pathway (ILAP) designation provides unique, end-to-end regulatory access pathway for Solid to work directly with the UK’s National Health System (NHS), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and health technology assessment (HTA) bodies: the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the All Wales Therapeutics and Toxicology Centre (AWTTC).
- Innovation Passport supports the potential for SGT-003 to become the first-to-market gene therapy in the UK for Duchenne muscular dystrophy.
SGT-003 is currently being evaluated in the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trial, which is enrolling participants at 15 active clinical trial sites across the US, UK, Italy and Canada. Additionally, Solid has activated the first clinical trial site and is screening participants for IMPACT DUCHENNE, an ex-US, Phase 3, randomized, double-blind, placebo-controlled clinical trial of SGT-003.
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