miRagen Therapeutics has reported positive outcomes from its Phase l clinical trial of MRG-106 to treat patients with mycosis fungoides (MF) form of cutaneous T-cell lymphoma (CTCL).
During the trial, cohorts were dosed using various routes of administration such as subcutaneous injection (SQ), intravenous infusion (IV infusion) and intravenous bolus injection (IV bolus).
Efficacy and tolerability of the drug were evaluated at 300mg, 600mg and 900mg doses for SQ and IV infusion and at 300mg for IV bolus.
Results have shown that 26 of 29 of the trial’s evaluable patients demonstrate improvement in modified severity weighted assessment tool (mSWAT) score, a measurement of the severity of skin disease over a patient’s entire body.
Four out of five patients treated with 300mg IV infusion have reportedly achieved a mSWAT reduction of 50% or more.
Furthermore, all eight patients who achieved a 50% or greater reduction in mSWAT and received long-term dosing were found to be capable of maintaining a durable response for longer than four months.
miRagen Therapeutics president and CEO William Marshall said: “We believe that the clinical activity observed with MRG-106 in CTCL continues to demonstrate that patients are experiencing meaningful improvement in total skin disease and that MRG-106 is generally well-tolerated at all doses tested.
“We have identified what we anticipate to be the appropriate therapeutic dose for the Phase ll clinical trial of MRG-106, and recently discussed the Phase l interim results and Phase ll clinical trial design with the US Food and Drug Administration (FDA).”
The company aims to begin the Phase ll clinical trial of MRG-106 in patients with CTCL in the second half of this year.