Shares of Unity Biotechnology, Inc. UBX plunged about 66.6% after itannounced that a phase II study onUBX0101, in patients with moderate-to-severe painful osteoarthritis (OA) of the knee, failed to meet the primary endpoint. The 12-week results from the studyshowed that there was no statistically significant difference between any arm of UBX0101 and placebo for the primary endpoint. The primary endpoint is an assessment of pain at 12 weeks using the WOMAC-A instrument, which is an established measurement of pain in OA.
UBX0101 is a senolytic small molecule inhibitor of the MDM2/p53 protein-protein interaction.
Shares of the company have slumped 42.4% year to date against the industry’s growth of 4.6%.
In the phase II study, 183 patients with moderate to severe painful OA of the knee were randomized to receive placebo, or 0.5 mg, 2.0 mg or 4.0 mg doses of UBX0101 via a single intra-articular injection.
UBX0101was well-tolerated at all doses and the adverse events were consistent with previous reports, with no treatment-related serious AEs.Only one patient discontinued the program because of an AE, which was an unrelated cardiovascular event. The most common treatment-emergent AE was procedural pain in the study knee.
The company does not plan to advance UBX0101 into pivotal studies.
Unity plans to complete the 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 2020.
Unity’s will focus on its ongoing ophthalmologic and neurologic disease candidate, UBX1325, which is being developed for age-related macular degeneration (AMD), diabetic macular edema and diabetic retinopathy. The investigational new drug (IND)-enabling studies for UBX1325 were completed in July 2020 and the company plans to initiate a phase I study in the second half of theyear with initial results expected in 2021.
Based on current operating plans, Unity believes that current cash, cash equivalents and investments are sufficient to fund operations well into 2022. At the end of the second quarter, however, the company stated that cash, cash equivalents and investments were sufficient to fund operations into the second half of 2021. The company announced that it entered into an $80-million debt facility with Hercules Capital in August 2020. This further strengthened its balance sheet and it has additional financial flexibility concerningthe development of its pipeline candidates.
Zacks Rank & Stocks to Consider
Unity currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Horizon Therapeutics Public Limited Company HZNP and Alimera Sciences Inc. ALIM. While Emergent and Horizon Therapeutics sport a Zacks Rank #1 (Strong Buy), Alimera carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $3.45 to $5.60 for 2020 and from $3.73 to $6.67 for 2021 over the past 60 days.
Horizon Therapeutics’ earnings estimates have increased from $1.77 to $2.87 for 2020 and from $2.72 to $4.30 for 2021 over the past 60 days.
Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days.
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