Unity, on rebound from disaster, shows promising results in early eye disease trial

Almost a year after abandoning its flagship program and declining shares, Unity Biotechnology appears to be back on track with positive data in its Phase 1 study in patients with advanced vascular eye disease.

The anti-aging biotech said on Tuesday that its small molecule inhibitor of Bcl-xL, a senolytic treatment, was well tolerated in patients with diabetic macular edema (DME) and age-related wet macular degeneration (AMD) wet).

Unity shares rose about 9% as they started trading on Tuesday morning.

The UBX1325 study was conducted in patients for whom anti-vascular endothelial growth factor (anti-VEGF) therapy was no longer considered to be beneficial. Anti-VEGF treatments include Lucentis from Roche, Eylea from Regeneron, Beovu from Novartis and Avastin from Roche.

UBX1325 showed improvements in retinal structure and vision in patients with DME and wet AMD in the Phase 1 study, although this only involved 12 patients.

“We believe that since we are seeing these effects in very advanced patients who have not been on anti-VEGF for several months, this drug has the potential for treatment as monotherapy, but also which could be combined with an anti-VEGF. VEGF, or might be suitable for people who discontinue anti-VEGFs because they are suboptimal responders, ”said CEO Anirvan Ghosh, Ph.D., in an interview with Fierce Biotech.

“Imaging data demonstrating structural improvements in the retina are compelling at this stage of clinical development and represent defined endpoints for improvement in disease,” said Jeffrey Heier, MD, director of the Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston, in a declaration.

Unity targets the cell biology of senescence, which involves cells that become dysfunctional in the context of disease. “Many of them are found in the retinal vasculature and can secrete inflammatory factors that will continue to damage the retina and lead to disease progression,” Ghosh said.

The first patient has already received a dose in a phase 2a study investigating the safety and efficacy of UBX1325 in a larger population of patients with DME. Data from this trial is expected in the first half of next year. Unity is also enrolling more patients with advanced wet AMD in the Phase 1 study to obtain more data to support a Phase 2a study in this patient population.

“We think that by going to a larger patient population who are less advanced, we could see even greater efficiency,” Ghosh said. Unity wanted to tackle a new mechanism since anti-VEGF treatments don’t work for all patients, Ghosh said, noting that the senoletic mechanism “offered an excellent intersection between a new biology that we wanted to explore and a disease where it was. there was a great need for new medical classes.

Over the next 18-20 months, Unity will begin exploring other systems with strong evidence for the biology of senescence.

“In neurology, these are very similar mechanisms for neurodegenerative diseases, and there is good evidence that there is an accumulation of senescence cells in the context of aging in the brain, and age is one of the factors. major risk factors for neurological diseases like Alzheimer’s disease, ”Ghosh said. mentionned.

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Ghosh became CEO of Unity in the months leading up to the pandemic, having served as the first head of R&D at Biogen, which recently gained approval for the Alzheimer’s drug Aduhelm.

Months after starting his new role, Ghosh had to lead Unity through an overhaul after the company decided to ditch its core knee pain program. The elimination of the program resulted in an approximately 30% reduction in Unity’s workforce last fall.

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Ghosh said Unity trusts UBX1325 and others in the works because they are based on completely different indications and mechanisms than the Knee program which was scrapped last year and left lingering questions about its entire platform as well as its future.

“We have a small, but super-concentrated workforce. The atmosphere is very positive. When you have these big pivots or changes, it may take a while for an organization to find its true north, but we were very clear on what we were going to do at this point, and we have been true to that commitment ” , said Ghosh.

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