PepGen Inc. announced that the first patient has been dosed in its CONNECT1-EDO51 Phase 2, open-label multiple ascending dose (MAD) clinical trial evaluating PGN-EDO51 for the treatment of Duchenne muscular dystrophy (DMD) patients amendable to an exon 51 skipping therapy. PepGen previously reported data from a Phase 1 trial evaluating P GN-EDO51 in 32 healthy adult volunteers. PGN-EDO51 also produced the highest levels of exon 51 skipping in healthy volunteers following a single dose when compared to publicly available clinical data for other exon 51 skipping approaches.

The CONNECT1-EDO 51 Phase 2 clinical trial is an open-label, MAD study, enrolling approximately 10 male patients of at least 8 years of age with DMD amenable to an exon 51 skipping approach to evaluate the safety and tolerability of PGN-EDO51. PGN-EDO 51, PepGen's lead clinical candidate for the treatment of DMD, utilizes the Company's proprietary Enhanced Delivery Oligonucleotide (EDO) technology to deliver a therapeutic oligonucleotide that is designed to target the root cause of this devastating disease. PepGen's Enhanced Delivery Oligonucleucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics.

These forward-looking statements include, without limitation, statements regarding the therapeutic potential and safety profile of product candidates including PGN-EDO51, technology, including EDO platform, the design, initiation and conduct of clinical trials, including the CONNECT1-EDO50 clinical trial, including expected timelines, dose levels, regulatory interactions, including development pathway for product candidates, and financial resources and cash runway. These risks and uncertainties include, but are not limited to risks related to: delays or failure to successfully initiate or complete ongoing and planned development activities for product candidates, including PGN-EDO 51; ability to enroll patients in and complete clinical trials, including the CON Connect1-EDO51 clinical trials, including the CON connectivity1-EDO51 clinical trial, including the CONNECT1 -EDO51 clinical trials; interpretation of clinical and preclinical study results may be incorrect, or that may not observe the levels of therapeutic activity in clinical testing that they anticipate based on prior clinical or preclinical results; product candidates may not be safe and effective or otherwise demonstrate safety and efficacy in clinical trials; adverse outcomes from regulatory interactions, including delays in regulatory review, clearance to proceed or approval by regulatory authorities with respect to the programs, including clearance to commence planned clinical studies of product candidates, including P GN-EDO51, or other regulatory feedback requiring modifications to development programs; changes in regulatory framework that are out of control; unexpected increases in the expenses associated with the company's control; unexpected increases in the costs associated with the company's financial resources and cash flow.