Dyne Therapeutics reports one-year DM1 trial data showing gains on several measures
Dyne Therapeutics reported additional one-year clinical data from the Phase 1/2 ACHIEVE trial of z-basivarsen in myotonic dystrophy type 1 (DM1), based on a pooled group of 25 to 26 participants from several dose cohorts. The company also disclosed a mean baseline hand-opening time of 8.3 seconds for the 71 participants in the registrational expansion cohort, whose topline data are still expected in the first quarter of 2027. The results are not from a single registrational-dose group, and the filing says only 8 of 26 pooled participants received the registrational dose for the full 12 months.
Key points
- Pooled group's hand myotonia (vHOT) improved 3.2 seconds from baseline at 6 months, versus a 0.4-second increase in the placebo group (N=14).
- At 12 months, the pooled group improved 1.2 seconds on the 5xSTS test and 4.8% on the QMT total score relative to baseline.
- Only 8 of 26 pooled participants received the 6.8 mg/kg registrational dose for the full 12 months analyzed.
- Topline data from the 71-participant registrational expansion cohort are planned for the first quarter of 2027.
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 29, 2026.
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