Summit Therapeutics PLC (NASDAQ: SMMT) saw its shares make a handy gain on Monday after the firm announced that it had completed the dosing for the patients in its Duchenne muscular dystrophy (DMD) trial.
Getting into the specifics, the firm announced the completion of the initial 24 weeks of dosing of ezutromid in patients with DMD in its Phase 2 clinical trial called PhaseOut DMD. With the achievement of this milestone, Summit continues to expect to report results from this initial 24-week dosing period in the first quarter of 2018.
For some quick background, PhaseOut DMD is a 48-week open-label Phase 2 clinical trial that has enrolled 40 patients at sites in the UK and the US. The trial aims to establish proof of concept of ezutromid and is evaluating a range of muscle structure, muscle health and functional endpoints.
Following the 48 weeks of treatment, patients have the option to continue onto an extension phase. The extension phase will be used to gather long-term safety and efficacy data and is expected to last until ezutromid either receives marketing approval in the relevant country or its development is discontinued.
Top-line data from the complete 48-week trial is expected in the third quarter of 2018.
Dr David Roblin, COO and Medical Officer of Summit, commented:
With the completion of the 24-week dosing period, we remain on track to conduct the planned biopsy, MRI and functional analyses and deliver the results for the initial dosing period during the first quarter of 2018,” “In the interim data readout, we aim to show a positive change following ezutromid treatment in muscle structure and health through the evaluation of muscle biopsies. This could potentially provide the first evidence of proof of mechanism for utrophin modulators in patients and give hope to those living with DMD.
Shares of Summit were last seen up over 7% at $11.58, with a consensus analyst price target of $31.00 and a 52-week range of $7.95 to $16.86.