Business
PepGen Reports Second Quarter 2023 Financial Results and Recent Corporate Developments
– Phase 2 open-label CONNECT1-EDO51 study open in Canada – – Potentially registrational, randomized, double-blind, placebo-controlled Phase 2 CONNECT2-EDO51
About this update from Pepgen Inc.
[{"type":"text","content":"– Phase 2 open-label CONNECT1-EDO51 study open in Canada – – Potentially registrational, randomized, double-blind, placebo-controlled Phase 2 CONNECT2-EDO51 multinational study expected to be initiated in the second half of 2023 – – Continue to pursue global strategy of initiating FREEDOM-EDODM1 clinical study in geographies outside the U.S. – – Continue to work closely with FDA to lift the clinical hold and initiate the Phase 1 FREEDOM-EDODM1 study in the U.S. as quickly as feasible – – Ended second quarter 2023 with cash and cash equivalents of $147.0 million; cash runway expected into 2025 – BOSTON, Aug. 08, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the second quarter ended June 30, 2023 and highlighted recent corporate developments. “PepGen continues to make strong progress across our pipeline of clinical and pre-clinical stage conjugated oligonucleotide therapies for neuromuscular and neurological diseases,\" said James McArthur, Ph.D., President and CEO of PepGen. “We continue to expect to report, from the CONNECT1 study, initial dystrophin production, exon skipping and safety data following 4 monthly doses of PGN-EDO51 in mid-2024. Learnings from this study will inform a planned global randomized clinical trial, designated CONNECT2, designed to support a potential accelerated or conditional approval pathway, subject to alignment with regulatory authorities.” Dr. McArthur added, “In parallel we continue to pursue our global strategy of opening our Phase 1 FREEDOM-EDODM1 study as well, and we continue to work closely with the FDA to address their questions regarding our IND for PGN-EDODM1 and lift the clinical hold in the U.S. as quickly as feasible.” Recent Corporate Highlights The Company is pursuing a global strategy of initiating its Phase 1 FREEDOM-EDODM1 study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1) in multiple geographies, pending alignment with regulatory authorities.In May 2023, PepGen announced that it received a clinical hold notice from FDA regarding its Investigational New Drug Application (IND) to initiate a Phase 1 study of PGN-EDODM1 in patients wit...