Newly refocused Unity's ophthalmology asset improves vision in phase 2

Unity Biotechnology seems to have gotten its crew together behind a common goal in ophthalmology, with the biotech announcing today that its treatment for diabetic macular edema improved vision in a mid-stage trial.

It’s good news for a biotech that has struggled through several waves of layoffs and other setbacks, including in February when half of its workforce was sent packing. The remaining staff will now have plenty to work on, as the phase 2 hit tees up the initiation of a pivotal trial in the second half of 2023.

UBX1325 met key safety and efficacy goals of the phase 2 Behold study, Unity said in a Tuesday release. The main goal of the trial was ocular and systemic safety and tolerability after a single injection as measured by the incidence of treatment-emergent adverse events. Key secondary endpoints included corrected vision, retinal stability and a measure of the number of patients who required rescue with another treatment.

At 24 weeks, a single dose of UBX1325 improved Best Corrected Visual Acuity, a common measure of vision impairment conducted via letter chart—which you read over during your yearly optometrist visit—compared to a sham treatment. Patients also maintained central subfield thickness, suggesting stabilization of the retinal structure, compared to the sham patients who experienced worsening. About 40% of patients receiving UBX1325 required a rescue, standard-of-care treatment, compared to just over 60% in the sham group who needed additional therapy.

The therapy demonstrated a favorable safety and tolerability profile, according to Unity. No cases of intraocular inflammation, retinal artery occlusion, endophthalmitis or vasculitis were observed.

Unity CEO Anirvan Ghosh, Ph.D., said that UBX1325 could reduce the treatment burden for patients while providing significant vision improvement.

“The durable effect we’ve now observed through six months following just a single injection of UBX1325 suggests it could represent a longer-lasting, disease-modifying treatment option for patients,” Ghosh added.

Patients in the trial had been on an anti-VEGF treatment for at least six months before enrolling. Drugs in this class include Genentech’s Avastin and Lucentis and Regeneron’s Eylea.

Unity Chief Medical Officer Jamie Dananberg, M.D., said that the Behold study will continue in a long-term extension to assess results at 48 weeks. This will show the durability of the treatment after today’s results suggested the therapy leads to disease modification. Results of the long-term extension are due in the third quarter of 2023. Unity is also expecting phase 2 data for UBX1325 from a study called Envision in wet age-related macular degeneration in the first quarter of 2023.

In addition, UBX1325 is being examined in diabetic retinopathy. The therapy is a small molecule inhibitor of Bcl-xL, a protein that controls whether a cell lives or dies, meaning it could help the retina repair itself from damage.

Unity reorganized its pipeline to focus on ophthalmology, specifically UBX1325, in February. Half its staff was dismissed in the process and a new plan was set out in an attempt to extend the company's cash runway into the first quarter of 2023. The workforce reduction followed a September 2020 cut of 30% of employees. Unity was previously focused on anti-aging. 

In an August earnings report, the company reported cash and cash equivalents of $64.5 million—with the end of the Q1 runway looming—as of the end of June. A public offering followed in August, raising $45 million in gross proceeds to fund the Behold and Envision studies and other general corporate purposes. 

Unity's shares were up about 8% Tuesday morning to $3.08, compared to a prior close of $2.86.