Earnings release
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UNITY BIOTECHNOLOGY UNITY Biotechnology , Inc. Reports Second Quarter 2021 Financial Results and Business Updates August 10 , 2021 UBX1325 demonstrates favorable tolerability in Phase 1 safety study and improvement in visual acuity and central subfield thickness in majority of patients with diabetic macular edema ( DME ) and wet age - related macular degeneration ( AMD ) Results from Phase 1 study of UBX1325 in additional patients with wet AMD expected by end of year UBX1325 Phase 2a proof - of - concept study enrolling patients with DME ; data expected first half of 2022 SOUTH SAN FRANCISCO , Calif . , Aug. 10 , 2021 ( GLOBE NEWSWIRE ) -- UNITY Biotechnology , Inc. ( UNITY ) [ NASDAQ : UBX ] , a biotechnology company developing therapeutics to slow , halt , or reverse diseases of aging , today reported financial results for the second quarter ended June 30 , 2021 . " This quarter has been exciting and productive , marked by the compelling data from the Phase 1 study of UBX1325 . In addition to the reassuring safety profile , we observed initial signs of efficacy in both vision and corresponding ocular structures in patients suffering from advanced DME and wet AMD for whom anti - VEGF therapy was no longer considered beneficial – and who in fact hadn't received any anti - VEGF therapy for at least three months . This initial data has generated strong enthusiasm and support from the physician community , and we have both completed the enrollment of additional wet AMD patients in our Phase 1 study and are rapidly recruiting in our international Phase 2a study in DME , " said Anirvan Ghosh , Ph.D. , chief executive officer of UNITY . " There's a large unmet need for treatment options beyond anti - VEGF therapy , and UBX1325 may fill that void as a senolytic option working through an entirely novel and potentially disease - modifying mechanism . We look forward to sharing additional data from the Phase 1 study in the coming months , and the results of the Phase 2a study in the first half of 2022. " Key Business Highlights Ophthalmology - UBX1325 Phase 1 Results In July , UNITY announced positive data from its Phase 1 safety study of UBX1325 in patients with advanced disease from DME or wet AMD for whom anti - VEGF therapy was no longer considered effective . In addition to a favorable safety and tolerability profile , UBX1325 , a small molecule inhibitor of Bcl - xL , showed rapid improvements in these advanced patients . Specifically , the majority of patients from this study showed a positive gain in key clinical measures of disease progression , including in best - corrected visual acuity ( BCVA ) , central subfield thickness ( CST ) , and sub- and intra - retinal fluid ( SRF , IRF ) . The following improvements in vision and retinal structure were observed as summarized below : Treatment of patients with UBX1325 resulted in the following clinical changes as of June 30 , 2021 : Gain in ETDRS Letters from Baseline in Best - Corrected Visual Acuity ( BCVA ) • Overall ( across all doses ) : 10 of 12 patients showed a gain in ETDRS letters from baseline in BCVA at 2 weeks ; 9 of 12 patients showed a gain at 4 weeks • In high dose groups ( 5 , 10 mcg ) : 6 of 6 patients showed a gain in ETDRS letters from baseline in BCVA at 2 weeks ; 5 of 6 patients showed a gain at 4 weeks Decrease in Central Subfield Thickness ( CST ) • Overall ( across all doses ) : 6 of 12 patients had a decrease ( improvement ) in CST at 2 weeks ; 5 of 12 patients showed reductions at 4 weeks • In high dose groups ( 5 , 10 mcg ) : 4 of 6 patients showed decrease in CST at 2 weeks ; 3 of 6 patients showed reductions at 4 weeks Reduction in Subretinal / Intraretinal Fluid • 3 of 4 patients with wet AMD had a reduction in subretinal / intraretinal fluid ( SRF / IRF ) , and improvement in disease- relevant pathology Based on these data , the Company has , as of August 5 , 2021 , completed the enrollment of additional patients with advanced wet AMD in the Phase 1 study to inform a potential Phase 2a study in wet AMD to start this fall . A parallel Phase 2a proof - of - concept study in DME is actively recruiting