Novartis has announced it is acquiring Gyroscope Therapeutics, the UK-based company behind an investigational dry ADM gene therapy that is the focus of key clinical trials in Australia.
The deal, which centres on the GT005 gene therapy, will see Novartis make an upfront payment of US$800 million (AU$1.1 billion) and potential additional milestone payments of up to US$700 million (AU$970 m). Closing of the transaction is subject to customary closing conditions including regulatory approvals.
With there being no approved treatments for geographic atrophy (GA) – also known as dry age-related macular degeneration (AMD) – it remains one of the most significant unmet needs in all retinal disease categories.
GT005 is designed as an AAV2-based, one-time investigational gene therapy for GA secondary to AMD that is delivered with a subretinal injection.
Its safety and efficacy is currently being evaluated in a Phase 1/2 clinical trial and two Phase 2 clinical trials.
These include the HORIZON and EXPLORE trials. Around 20 Australians with dry AMD are expected to take part in both Phase 2 studies, with Dr Tom Edwards the first to deliver the therapy locally at The Royal Victorian Eye and Ear Hospital in Melbourne last year.
According to Novartis, GT005 aims to restore balance to an overactive complement system, a part of the immune system, by increasing production of the CFI protein. Complement overactivation can lead to inflammation that damages healthy tissues, and it has been strongly correlated with the development and progression of AMD.
The CFI protein regulates the activity of the complement system. It is believed that increasing CFI production could reduce inflammation, with the goal of preserving eyesight.
GT005 has received Fast Track designation from the US Food and Drug Administration for GA. Gyroscope also has several additional assets in its pipeline in early discovery for retinal diseases.
“With our own pioneering research in ocular gene therapies and our experience gained from bringing Luxturna to inherited retinal dystrophy patients outside of the US, Novartis has a well-established expertise in ocular gene therapies that will position us well to continue developing this promising one-time treatment,” Novartis president Ms Marie-France Tschudin said.
“This acquisition is one more step forward in our commitment to delivering innovation in ophthalmology to treat and prevent blindness worldwide.”
Until closing, Novartis and Gyroscope Therapeutics will continue to operate as separate and independent companies.