Novartis Acquires Gyroscope Therapeutics, Maker of Investigational Gene Therapy for Geographic Atrophy
Novartis has bolstered it gene therapy portfolio after entering into a definitive agreement to acquire all of the outstanding share capital of the UK-based ocular gene therapy company Gyroscope Therapeutics.
Novartis will make an upfront payment of $800 million and potential additional milestone payments of up to $700 million. Closing of the transaction is subject to customary closing conditions including regulatory approvals. Until closing, Novartis and Gyroscope Therapeutics will continue to operate as separate and independent companies.
GT005 is designed as an AAV2-based, one-time investigational gene therapy for GA secondary to AMD that is delivered under the retina. 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.3 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 a person’s eyesight.
The safety and efficacy of GT005 for the treatment of GA secondary to AMD is currently being evaluated in a phase 1/2 clinical trial and two phase 2 clinical trials.4,5,6 GT005 has received Fast Track designation from the FDA for the treatment of people with GA.
There are no approved treatments for GA, making it one of the most significant unmet needs remaining in retinal diseases2.
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,” Marie-France Tschudin, President, Novartis Pharmaceuticals, said in a company news release. “This acquisition is one more step forward in our commitment to delivering innovation in ophthalmology to treat and prevent blindness worldwide.”
References
1 Schmitz-Valckenberg S, et al. Natural History of Geographic Atrophy Progression Secondary to Age-Related Macular Degeneration (Geographic Atrophy Progression Study) Ophthalmology 2016;123:361-368.
2 National Institute of Health. “Age-Related Macular Degeneration”. Accessed December 2021. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration.
3 Holz FG, et al. Geographic Atrophy: Clinical Features and Potential Therapeutic Approaches. Ophthalmology 2014;121(5):1079-1091.
4 U.S. National Library of Medicine. “EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (EXPLORE”). Accessed December 2021. https://clinicaltrials.gov/ct2/show/NCT04437368?term=geographic+atrophy%2C+GT005&cond=Macular+Degeneration&draw=2&rank=1#contacts
5 U.S. National Library of Medicine. “HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005”. Accessed December 2021. https://clinicaltrials.gov/ct2/show/NCT04566445?term=GT005&draw=2
6 U.S. National Library of Medicine. “FocuS: First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD”. Accessed December 2021. https://clinicaltrials.gov/ct2/show/NCT03846193?term=FOCUS&cond=Geographic+Atrophy&draw=2&rank=1
7 American Macular Degeneration Foundation. “Macular Degeneration”. Accessed December 2021. https://www.macular.org/what-macular-degeneration.