secwatch.observer — SEC 8-K summary
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Issuer:     PepGen Inc. (PEPG)
CIK:        0001835597
Form:       8-K
Filed at:   2024-03-04T23:59:59+00:00
Accession:  0000950170-24-024350
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PepGen gets UK MHRA clearance to start Phase 2 trial of PGN-EDO51 for DMD
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- MHRA authorized CTA for CONNECT2-EDO51 Phase 2 trial of PGN-EDO51 in DMD patients amenable to exon 51 skipping.
- Trial is randomized, placebo-controlled, multiple ascending dose, enrolling ~20 boys/young men aged ≥6 years.
- PGN-EDO51 is an oligonucleotide therapy; data from CONNECT1 (ongoing Phase 1) plus CONNECT2 could support accelerated approval.
- Starting dose 5 mg/kg escalating to 10 mg/kg and potentially higher; muscle biopsies at baseline and week 25 to assess exon skipping and dystrophin production.
- Participants have option for open-label extension after 24-week treatment period.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835597/000095017024024350/0000950170-24-024350-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835597/000095017024024350/pepg-20240304.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-024350

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer