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A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This Year
A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This ...
About this update from Cybin, Inc.
A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This Year A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This Year /* Style Definitions */ span.prnews_span { font-size:8pt; font-family:"Arial"; color:black; } a.prnews_a { color:blue; } li.prnews_li { font-size:8pt; font-family:"Arial"; color:black; } p.prnews_p { font-size:0.62em; font-family:"Arial"; color:black; margin:0in; } PR Newswire Issued on behalf of Helus Pharma™Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., says its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% enrollment, keeping the FDA Breakthrough-designated program on track for a topline data readout in Q4 2026.NEW YORK and TORONTO, June 26, 2026 /PRNewswire/ -- USA News Group News Commentary, In drug development, enrollment is the quiet variable that decides whether a promising therapy ever reaches a data readout on schedule. Late-stage psychiatric trials are notoriously hard to fill, which is why a clean enrollment update is meaningful. On June 24, 2026, Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., reported that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder has surpassed 86% enrollment and is progressing as planned, keeping the program on course for a topline data readout in the fourth quarter of 2026. Key TakeawaysHelus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP) reported that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder (MDD) has surpassed 86% enrollment and is progressing as planned.HLP003 has previously been granted Breakthrough Therapy Designation by the U.S. FDA, and the Company says it remains on track for a topline data readout in Q4 2026.Company-reported Phase 2 results showed a ~23-point MADRS reduction from baseline at 12 months (after two 16 mg doses three weeks apart), with response/remission rates of 75% at week 18 improving to 100% response and 71% remission at 12 months — figures that have not been evaluated by the FDA.An Enrollment Milestone That Matters"We are pleased with the continued progress of the APPROACH study as we surpass 86% enrollment," said Eric So...