DSMB backs further dosing in Precision's PBGENE-DMD Duchenne gene-editing trial
An independent safety board found no serious adverse events in the first PBGENE-DMD patient through week eight and endorsed treating more patients in Part 1 of FUNCTION-DMD.
Precision BioSciences said on 5 November 2026 that an independent Data Safety Monitoring Board (DSMB) has reviewed safety data from the first patient dosed with PBGENE-DMD in the Phase 1/2 FUNCTION-DMD study in Duchenne muscular dystrophy.
According to the company, no serious adverse events and no adverse events of special interest were observed through week eight of follow-up. On that basis, the board endorsed dosing additional patients in Part 1 of the study.
Precision said it expects to share safety and efficacy updates throughout 2027. The summary available does not give further details on dose levels, the number of patients planned for Part 1, or the specific efficacy measures to be reported.
As general context, a DSMB is an independent group of experts that periodically reviews accumulating safety data in a clinical trial and can recommend that a study continue, be modified or be paused. In early-phase gene-editing studies, such reviews often shape how quickly a sponsor can move from a first patient to further cohorts.
What it means for your team
- The DSMB's endorsement lets FUNCTION-DMD proceed to additional patients in Part 1, but this rests on a single patient's eight-week safety data, so it is a very early signal.
- Pharmacovigilance teams tracking gene-editing programmes should note that no serious adverse events or adverse events of special interest were reported at this stage.
- Regulatory and market-access observers should expect the next substantive data from 2027, as the company has guided to updates throughout that year.
Company's press release (SEC filing): Precision Biosciences Inc ↗
Article written by VigiEye from the official source (Precision Biosciences Inc). Claims are the company's own. AI-assisted; check the source before acting.