GenSight to start clinical testing combination of gene therapy and wearable device

Posted on: Thursday 11 January 2018

GenSight will start a clinical trial in the UK testing a combination of gene therapy and a wearable device to restore sight in patients with retinitis pigmentosa.

The UK Medicines and Healthcare Regulatory Agency (MHRA) has accepted GenSight’s application to run a first clinical trial in the UK testing a new type of therapy with the potential to treat all forms of retinitis pigmentosa.

The Phase I/II trial, called PIONEER, will study the safety and tolerability of GenSight’s therapy, called GS030, in patients with end-stage retinitis pigmentosa with vision not better than “counting fingers.” The company expects to treat the first patient in the first quarter of 2018 and will measure the outcome after a year.

GS030 is a combination of a gene therapy and a wearable “optronic visual stimulation device.” The gene therapy step introduces a gene that encodes for a protein sensitive to light into specific neurons. The wearable device is a pair of goggles that capture images and transform them into light patterns that stimulate the light-sensitive proteins in the neurons, which send the visual signal to the brain.

The need to transform the visual signals stems from the fact that the light-sensitive protein delivered to the neurons has less sensitivity than that of healthy human photoreceptors. This information is processed in a pocket computer the size of a mobile phone.

CEO and co-founder Bernard Gilly stated that the therapy could also be extended to other retinal diseases such as dry age-related macular degeneration (dry-AMD).