X4 Pharmaceuticals, Inc. (XFOR) Q2 2024 Earnings Call

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WEBVTT 00:00:00.031 -- 00:00:02.195 meaningful levels. 00:00:02.195 -- 00:00:06.822 Finally, we'll be also looking for continued tolerability and safety of Mavericks IV 00:00:06.822 -- 00:00:11.607 as seen in all of our other clinical programs to date. 00:00:11.951 -- 00:00:17.460 In June, we also announced the initiation of our Global Pivotal Phase III clinical trial, 00:00:17.460 -- 00:00:22.828 branded the FORWARD Study, evaluating the efficacy, safety, and tolerability 00:00:22.828 -- 00:00:28.050 of oral once daily Mavericks IV with and without stable doses of GCSF 00:00:28.050 -- 00:00:33.339 in people with congenital acquired primary autoimmune or idiopathic 00:00:33.339 -- 00:00:37.987 CN who are experiencing recurrent and or serious infections. 00:00:37.987 -- 00:00:43.396 The 52-week forward trial is a randomized, double-blinded, placebo-controlled, 00:00:43.396 -- 00:00:48.395 multicenter study aiming to enroll 150 participants. 00:00:48.395 -- 00:00:52.760 The clinical operations team is in full swing, opening up sites, and we are on track 00:00:52.760 -- 00:00:56.362 to fully enroll the trial in mid-2025. 00:00:57.126 -- 00:01:02.332 We believe that the interim Phase II CN data presented to date strongly support our decision 00:01:02.332 -- 00:01:06.337 to initiate the Phase III trial as well as its design. 00:01:06.337 -- 00:01:10.923 Importantly, we believe that the interim results de-risk the Phase III trial, given that 00:01:10.923 -- 00:01:16.209 the ANC increases seen in CN patients to date mirror those in our successfully completed 00:01:16.209 -- 00:01:21.351 IV-WIM Phase III trial. where similar levels of ANC increases led 00:01:21.351 -- 00:01:27.837 to clinical benefit by reducing the frequency, duration, and severity of infections. 00:01:28.2...