{"id":764986,"date":"2023-06-21T07:03:16","date_gmt":"2023-06-21T11:03:16","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/unity-announces-design-of-phase-2b-aspire-study-evaluating-ubx1325-in-diabetic-macular-edema-dme\/"},"modified":"2023-06-21T07:03:16","modified_gmt":"2023-06-21T11:03:16","slug":"unity-announces-design-of-phase-2b-aspire-study-evaluating-ubx1325-in-diabetic-macular-edema-dme","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/unity-announces-design-of-phase-2b-aspire-study-evaluating-ubx1325-in-diabetic-macular-edema-dme\/","title":{"rendered":"UNITY Announces Design of Phase 2b ASPIRE Study Evaluating UBX1325 in Diabetic Macular Edema (DME)"},"content":{"rendered":"
\n

\n Phase 2b trial is a randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 (foselutoclax)<\/em>
\n compared to aflibercept over 24 weeks<\/em>
\n \n <\/p>\n

\n First novel senolytic therapeutic candidate to be evaluated head-to-head against standard of care anti-VEGF in DME<\/em>\n <\/p>\n

SOUTH SAN FRANCISCO, Calif., June 21, 2023 (GLOBE NEWSWIRE) — UNITY Biotechnology, Inc. (\u201cUNITY\u201d) [Nasdaq: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced the design of its Phase 2b ASPIRE clinical trial, which will evaluate UBX1325 (foselutoclax) head-to-head against aflibercept in previously treated patients with active diabetic macular edema (DME) who are not achieving optimal benefit from standard of care. UNITY expects to begin activating clinical trial sites in the third quarter and dose the first patient in the fourth quarter of 2023.<\/p>\n

\u201cThe Phase 2b ASPIRE Study is designed to provide a clear and robust comparison between UBX1325 and the standard of care aflibercept in a head-to head trial in patients with DME,\u201d said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. \u201cParticipants in the study drug arm will receive three doses of UBX1325 over the duration of the study, in a frequency that mirrors the real-world dosing schedule in the aflibercept arm. Based on the significant improvement in vision and durable effect observed with UBX1325 in our Phase 2 BEHOLD study, we are excited to explore the potential benefit of UBX1325 as a monotherapy in patients with DME who are no longer benefiting from standard anti-VEGF therapy.\u201d<\/p>\n

\n ASPIRE Trial Design<\/strong>\n <\/p>\n

The Phase 2b ASPIRE study is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept. Patients will be randomized 1:1 to receive either 10 \u03bcg UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months.<\/p>\n