{"id":742710,"date":"2023-03-27T07:33:26","date_gmt":"2023-03-27T11:33:26","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/unity-biotechnology-announces-results-from-phase-2-envision-study-of-ubx1325-in-patients-with-wet-age-related-macular-degeneration\/"},"modified":"2023-03-27T07:33:26","modified_gmt":"2023-03-27T11:33:26","slug":"unity-biotechnology-announces-results-from-phase-2-envision-study-of-ubx1325-in-patients-with-wet-age-related-macular-degeneration","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/unity-biotechnology-announces-results-from-phase-2-envision-study-of-ubx1325-in-patients-with-wet-age-related-macular-degeneration\/","title":{"rendered":"UNITY Biotechnology Announces Results from Phase 2 ENVISION Study of UBX1325 in Patients with Wet Age-Related Macular Degeneration"},"content":{"rendered":"
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\n UBX1325 monotherapy did not achieve non-inferiority through 24 weeks due, in part, to an unexpected 3.5 letter gain in the anti-VEGF control arm<\/em>\n <\/p>\n

\n UBX1325 maintained visual acuity in patients with ongoing active disease through 24 weeks with less than one letter mean decrease from baseline<\/em>\n <\/p>\n

\n 52% of UBX1325-treated patients did not require anti-VEGF treatment through 24 weeks<\/em>\n <\/p>\n

\n Company to share 48-week BEHOLD DME data in April and intends to initiate Phase 2b study in DME in second half of 2023<\/em>\n <\/p>\n

\n UNITY to host investor call today, March 27, at 8:00 a.m. ET<\/em>\n <\/p>\n

SOUTH SAN FRANCISCO, Calif., March 27, 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 results from Part A of the Phase 2 ENVISION study of UBX1325 in patients with wet age-related macular degeneration (AMD) who were not achieving optimum benefit with their ongoing anti-VEGF therapy. UBX1325 treatment generally maintained visual acuity for 6 months (change of -0.8 ETDRS letters from baseline), with a majority of patients not requiring any anti-VEGF rescue. Patients in the every 8-week aflibercept arm had an early and unexpected gain of 3.5 letters at week 2 which was mostly maintained for the duration of the study. As a result of the strength on the control arm, the study did not meet the non-inferiority threshold compared to aflibercept through 24 weeks.<\/p>\n

\u201cMaintenance of visual acuity in hard-to-treat patients with active disease after withdrawal of their anti-VEGF therapy suggests that UBX1325 had an active treatment effect in wet AMD. We continue to be impressed with the durability of effect of UBX1325 in this patient population,\u201d said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. \u201cFollowing a full analysis of ENVISION results, we will assess and optimize our resource allocation for future development of UBX1325. In the weeks ahead we will provide an update on Part B of the ENVISION study, and importantly, share 48-week data from the Phase 2 BEHOLD DME study. In DME, UBX1325 showed strong evidence of biologic activity and improvement in visual acuity \u2013 and, as a result, we plan to initiate a Phase 2b study in the second half of this year.\u201d<\/p>\n

The ENVISION study enrolled 51 patients with an average baseline visual acuity of 60.2 ETDRS letters who had ongoing active disease with a baseline CST of approximately 370 \u00b5m and had been on anti-VEGF treatment for at least 6 months. On average, patients received approximately 4 anti-VEGF injections in the 6 months prior to enrollment. At enrollment, all patients received a single run-in injection of aflibercept. Within 4-8 weeks following the run-in injection, patients were randomized to receive either (a) an injection of UBX1325 at week 0 and at week 4, or (b) an injection of aflibercept at week 0 and every 8 weeks thereafter, and followed for 24 weeks.<\/p>\n

\n Phase 2 ENVISION data through 24 weeks:<\/strong>\n <\/p>\n