San Francisco-based UNITY Biotechnology launched a restructuring program to focus on cellular senescence in ophthalmology and neurology. As part of the plan, it is decreasing its workforce by about 30% to optimize capital. The company expects to have 75 full-time employees by the end of the year.
On August 17, the company reported 12-week data from its Phase II trial of UBX-101 in moderate-to-severe painful osteoarthritis (OA) of the knee. The drug failed to demonstrate improvement over placebo. They abandoned the program, which is a p53/MDM2 interaction inhibitor.
The company’s other programs include UBX1325 and UBX1967, which is being developed for age-related macular degeneration (AMD), diabetic macular edema, and diabetic retinopathy; and assets for pulmonary, neurology and other areas. The pulmonary indications include idiopathic pulmonary fibrosis and the neurology indications include neurodegeneration and cognition.
The Investigational New Drug (IND)-enabling studies for UBX1325 were completed in July and the company hopes to initiate a Phase I trial in the second half of this year with initial data available in 2021.
The company hopes that the restructuring and job cuts will provide enough cash to run through mid-2022. This is when they expect data for the ophthalmology programs will be available. As of June 30, the company had $111.8 million in cash and cash equivalents.
Unity focuses on diseases of aging, with the theory that these diseases are driven by senescent cells. That is to say, cells that are no longer dividing, but are not dead, either; they still produce large amounts of proteins that are associated with aging. As those senescent cells accumulate, the proteins affect the eyes, heart, brain and joints. The drugs they develop are designed to eliminate senescent cells.
UBX1325 is a small molecule that blocks Bcl-xL. This protein inhibits cell death. Although the pathway involved has been studied in cancer indications, Unity has focused on using Bcl inhibitors to clear senescent cells that are associated with age-related diseases of the eye.
Unity licensed the compound from China-based Ascentage Pharma Group for non-cancer indications. UBX1967 came along as a back-up program in a June 29 amendment to the deal.
“Unity is a pioneer in the development of therapeutics targeting senescent cells at the crux of many age-related diseases, and we will continue to build on this scientific foundation as we advance our pipeline,” said Anirvan Ghosh, chief executive officer of Unity. “At Unity, we have an extraordinary team that has contributed greatly to the advancement of this field, and we are deeply grateful for the contributions that all of our employees have made. Moving forward we will have a leaner and more agile team, which is well-resourced to advance our pipeline programs to key milestones.”
Ghosh added, “We are excited about advancing Unity’s lead ophthalmology program, UBX1325, into clinical studies in patients with diabetic macular edema, an indication with a well-defined development path and objective endpoints. In addition, I see significant opportunities emerging from programs in our preclinical pipeline targeting ophthalmologic and neurologic disease. I look forward to using my experience leading drug discovery and development programs in these areas to advance the development of a new class of high efficacy therapies.”
In summary, the remaining programs include UBX1325, which expects to begin a Phase I trial in diabetic macular edema before the end of the year; UBX1967 is described as a molecularly distinct backup to UBX1325; its neurology programs will focus on neurodegenerative diseases; and its research programs will evaluate therapeutic modalities beyond small molecule approaches for modulating senescent cell biology.