GT005

Unassigned

New Medicines

Geographic atrophy in patients with age-related macular degeneration

Information

Advanced therapy medicinal product (ATMP)
Gyroscope Therapeutics
Gyroscope Therapeutics

Development and Regulatory status

Phase II Clinical Trials
None
None
Feb 20 · Gyroscope announces the successful completion of a £50.4 million Series B financing. With this new round of financing, Gyroscope will continue to advance the clinical development of GT005, the manufacturing platform to meet patient need worldwide, and a second-generation Orbit Subretinal Delivery System (SDS) [3].

Category

A retinal gene therapy consisting of a recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor
AMD is characterised by the appearance of drusen in the macula, accompanied by choroidal neovascularisation (wet AMD) or geographic atrophy (dry AMD). The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more. Dry AMD is the most common form of AMD, occurring in 90% of cases. AMD is the most common cause of severe visual impairment in older adults in the developed world [1].
Geographic atrophy in patients with age-related macular degeneration
Intraocular

Trial or other data

Mar 20 · PI/II FOCUS trial is recruiting [2].
Dec 18 · PI/II FOCUS trial to assess the safety and biological activity of a single dose of GT 005 subretinal injection in patients with geographic atrophy due to dry AMD starts (GT005-01; NCT03846193). The non-randomised, open-label, dose-escalation trial is enrolling 35 adults in the UK; sites are Bristol Eye Hospital, Moorfields Eye Hospital, Manchester Eye Hospital, Oxford University Hospital and Sunderland Eye Infirmary. Primary outcome is safety; secondary outcomes include change from baseline in GA size measured in mm2 and change from baseline in retinal drusen volume measured in mm3. The study is due to complete Jun 21 [2].