Unity Bio’s Pain Drug Flunks Phase II Arthritis Trial

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South San Francisco-based UNITY Biotechnology reported that the 12-week results from its Phase II study of UBX0101 in moderate-to-severe painful osteoarthritis (OA) of the knee failed to show improvement over placebo. As such, they do not plan to continue to progress the drug into pivotal trials and will shift the company’s focus, in the near-term, to ongoing programs for ophthalmologic and neurologic diseases.

UBX0101 is a p53/MDM2 interaction inhibitor. In the Phase II study, 183 patients with moderate to severe painful OA of the knee were split to receive placebo, 0.5 mg, 2.0 mg or 4.0 mg of UBX0101 by way of a single intra-articular injection. The drug was well-tolerated at all doses and the adverse events were consistent with previous reports, with no treatment-related serious AEs and only a single patient discontinued because of an AE, which was an unrelated cardiovascular event. However, at the 12-week readout, there was no statistically significant difference between those receiving the drug and patients receiving the placebo in change of baseline in WOMAC-A, a measurement of pain in OA.

“Osteoarthritis of the knee is a debilitating disease for many individuals,” said Jamie Dananberg, chief medical officer of UNITY. “While we are disappointed in the outcome of the 12-week results of the Phase II study of UBX0101, I would like to acknowledge our team’s hard work and commitment to executing a robust study that has provided clear results.”

Unity plans to complete collection of the trial’s 24-week data, as well as data from the ongoing Phase Ib high-dose, repeat-dose study in the second half of this year. Full data from the Phase II and Ib trials will be presented at a future medical conference.

 
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The company has had a great deal of success raising money. It initially raised $22 million in venture capital and another $85 million in a May 2018 initial public offering. The company’s focus is on killing senescent cells. They are essentially aging cells that aren’t quite dead but aren’t actually doing anything anymore. They build up in the body and are part of what makes people feel old—related to achy joints, diminished eyesight and some diseases of aging, potentially Alzheimer’s. Unity’s theory is that if you can kill those senescent cells, you can eliminate many of the symptoms of aging.

In March of this year, Biogen veteran Anirvan Ghosh took over the reins of the company from Keith Leonard. Leonard continued as chairman of the board of directors. Ghosh was head of research and development at Biogen, where he was responsible for preclinical development as well as early and mid-stage development of Biogen’s complete therapeutic pipeline. He also participated in expanding Biogen’s portfolio via key partnerships, including buying early-stage assets in Alzheimer’s disease, schizophrenia, ophthalmology, and others.

Unity’s other pipeline assets 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 indicates include idiopathic pulmonary fibrosis and the neurology indications include neurodegeneration and cognition. None are as advanced as UBX0101 was.

The Investigational New Drug (IND)-enabling studies for UBX1325 were completed in July of this year and hopes to initiate a Phase I study in the second half of this year with initial results available in 2021.

At the company’s second-quarter financial report on July 31, Unity indicated it has cash, cash equivalents and marketable securities worth $111.8 million as of June 30. Operating loss for the quarter was $23.3 million with cash used in operations during the six-month period ending June 30 was $44.4 million. Research and development expenses decreased by $2.3 million for the quarter, primarily due to a decrease of $5.3 million in preclinical and manufacturing expenses partially offset by a $1.8 million increase in UBX0101-related clinical trial costs.

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