UNITY Biotechnology (UBX) Provides Pipeline and Business Updates

UNITY Biotechnology, Inc. (UNITY) (NASDAQ: UBX), a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today provided pipeline and business updates.

Recent Highlights and Business Updates

Osteoarthritis – UBX0101In October 2019 UNITY announced that the first patient had been dosed in a Phase 2 study of UBX0101, an inhibitor of the MDM2/p53 protein-protein interaction, in patients with moderate-to-severe osteoarthritis (OA) of the knee. The study is now fully enrolled with 183 patients. The study is randomized, double-blind, and placebo-controlled and will evaluate three doses (0.5 mg, 2.0 mg and 4.0 mg) of UBX0101 administered via a single intra-articular injection. Both 12- and 24-week results are now expected in the second half of 2020.

"We are pleased to announce the completion of enrollment ahead of schedule in our Phase 2 study of UBX0101 in patients with moderate-to-severe osteoarthritis of the knee," said Keith Leonard, chairman and chief executive officer of UNITY. “We believe the rapid enrollment of this study can, in part, be explained by the significant unmet need of patients suffering from this debilitating condition. We now anticipate that both the 12-week and 24-week data will be available in the second half of this year.”

UNITY has also dosed the first patients in a Phase 1b study to explore the safety, tolerability and initial efficacy of a higher dose (8.0 mg) and repeated doses (4.0 mg x 2, separated by 1 month) of UBX0101. The study is expected to enroll approximately 36 patients with 12-week results expected in the second half of 2020.

OphthalmologyUNITY’s lead ophthalmology candidates, UBX1325 and UBX1967, are currently in the final phases of Investigational New Drug (IND) enabling non-clinical toxicology studies. Both senolytic molecules are inhibitors of particular members of the Bcl-2 family of apoptosis regulatory proteins which have shown distinct pharmacokinetic profiles in preclinical studies. UNITY intends to complete IND-enabling studies for both molecules prior to selecting the first molecule to advance to a first-in-human study to explore safety and tolerability of this novel mechanism of action for age-related eye diseases. UNITY expects to initiate a Phase 1 safety study for this program in the second half of 2020. The overall clinical program is directed at multiple age-related diseases of the eye, such as age-related macular degeneration, diabetic retinopathy and diabetic macular edema.

Cash UpdateAs of December 31, 2019 cash, cash equivalents and investments were $125.0 million (unaudited). UNITY expects this is sufficient to fund operations into the second half of 2021.

UNITY expects to release its audited financial results for 2019 on March 11, 2020.

You May Also Be Interested In

• SanDisk stock target lifted by Citi on continued demand strength
• American Outdoor Brands (AOUT) Tops Q4 EPS by 14c
• JPMorgan Downgrades Spire (SR) to Neutral