With another $148M in the bank, Gyroscope Therapeutics looks to hustle its AMD gene therapy through mid-stage tests
A month and a half later, Gyroscope Therapeutics’ Phase I/II win for its dry-AMD gene therapy is already paying off. On Friday, the biotech took the wraps off a $148 million Series C round to advance the candidate through two Phase II trials in patients with a debilitating eye disorder that causes gradual and permanent blindness.
Syncona — which founded Gyroscope with Cambridge Enterprise — contributed $42.3 million to the Series C round, and now maintains a 54% stake in the London-based biotech.
Spark’s costly Luxturna made waves when it became the first gene therapy approved for inherited blindness back in 2017. Since then, other gene therapies for rare eye disorders have advanced in development — but none have been approved for dry, age-related macular degeneration (AMD), a leading cause of blindness in people over 50 years old. About 85% to 90% of people with AMD have the dry type, according to Gyroscope.
Gyroscope’s lead candidate, GT005, is currently in two Phase IIs for patients with geographic atrophy, an irreversible degeneration of retinal cells caused by dry-AMD. The candidate is injected under the retina to increase production of the Complement Factor I protein, which Gyroscope believes could dampen an overactive complement system that’s been tied to worsening atrophy in AMD patients.
“We recently announced encouraging Phase I/II clinical trial data with our lead investigational gene therapy, GT005, that give us confidence in its potential as a treatment for geographic atrophy and are continuing to advance our Phase II clinical programme,” CEO Khurem Farooq said in a statement.
Farooq, a Genentech vet, oversaw commercial activities for the wet-AMD drug Lucentis and pre-launch work for Roche’s lampalizumab, a dry-AMD candidate that was dropped after failing two Phase III trials in 2017.
In a Phase I/II dose-escalation trial, patients who responded to GT005 saw a 146% increase in their vitreous Complement Factor I levels as well as a decrease in downstream biomarkers tied to geographic atrophy for patients with dry AMD, according to data released in mid-February.
At an interim check-in, nine out of 10 patients across four cohort groups saw increased CFI levels after receiving the therapy, and eight of those nine maintained elevated levels of CFI after six months, Gyroscope said.
“Consistently we’re hitting the targets we want to hit in the downstream amplification loop,” CMO Nadia Waheed told Endpoints News last month. “Everything so far looks like it’s pointing in the right direction.”
The Series C funds will also be used to advance Gyroscope’s early-stage pipeline and delivery tech, according to a statement. The round was led by Forbion’s Growth Opportunities Fund, with a hand from Sofinnova Investments, funds and accounts advised by T. Rowe Price Associates, Tetragon Financial Group Limited, an undisclosed healthcare-focused fund, Fosun Pharma and Cambridge Innovation Capital.
Wouter Joustra and Maha Katabi, general partners at Forbion and Sofinnova, respectively, are joining the board. And director Dominic Schmidt is on his way out.
“With the expansion of the Board it is the right time for Dominic (Schmidt) to step down from his position as Director. We thank Dominic for his key role in the launch and growth of Gyroscope and his support of the Company,” chief investment officer Chris Hollowood wrote in a statement.
Last month, Waheed told us the Phase I/II FOCUS trial would finish enrollment by the end of 2021, and that the team was “on track” to fill out enrollment in the two Phase II efficacy trials.
A correction has been made to reflect that Luxturna is the only ocular gene therapy currently approved.