Solid Biosciences stock rises after gene therapy receives UK innovation designation

Investing.com -- Solid Biosciences Inc. (NASDAQ:SLDB) stock rose 4.6% on Thursday after the company announced that its investigational gene therapy for Duchenne muscular dystrophy, SGT-003, has received an Innovation Passport designation under the UK’s new Innovative Licensing and Access Pathway (ILAP).

The Innovation Passport serves as the entry point to ILAP, which aims to accelerate time to market and facilitate patient access to new medicines in the UK. This designation will enable Solid Biosciences to have enhanced interactions with regulators and access to development tools designed to expedite regulatory timelines.

SGT-003 is among the first three investigational medicinal products to join the new ILAP program, which selectively focuses on transformative products addressing unmet clinical needs. The designation activates the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and ILAP partner agencies to develop a product-specific roadmap for regulatory and development milestones.

"Receiving the Innovation Passport designation is further recognition of SGT-003’s potential to transform the treatment paradigm for those living with Duchenne," said Jessie Hanrahan, Chief Regulatory & Preclinical Operations Officer of Solid Biosciences.

The company is currently evaluating SGT-003 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 clinical trial of SGT-003.

Duchenne muscular dystrophy is a rare genetic disorder characterized by progressive muscle degeneration and weakness due to alterations in a protein called dystrophin that helps keep muscle cells intact.

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