SPARC’s Baclofen GRS fails to meet primary end point in placebo controlled studies

The study consisted of a total of 293 subjects in the intent to treat population

Sun Pharma Advanced Research Company (SPARC) announced the top-line results of the Phase III efficacy study and duration of action study for Baclofen GRS. The Phase III efficacy study (CLR_09_21) was a placebo controlled randomised discontinuation study that investigated the efficacy and safety of Baclofen GRS in patients with spasticity due to multiple sclerosis.

The primary efficacy outcome was the proportion of subjects who experienced loss of efficacy following discontinuation of Baclofen GRS. Loss of efficacy was defined as becoming ‘minimally worse’, ‘much worse’ or ‘very much worse’, and experiencing a ≥1 unit increase in the modified Ashworth score, following discontinuation of drug. The study consisted of a total of 293 subjects in the intent to treat population.

Although there was a trend towards a difference in treatment failure rates between placebo and Baclofen GRS following drug discontinuation, the results did not reach statistical significance (p~0.20).

The subject global impression of severity score (SGIS) was assessed as a secondary endpoint.

Results for this endpoint were statistically significant, and favoured Baclofen GRS (p<0.05). Several other endpoints, such as spasm frequency and nighttime awakenings, also favoured Baclofen GRS (both p<0.001).

The Phase III duration of action study (CLR_11_03) was a double-blind, randomised, placebo-controlled, parallel group trial to evaluate the duration of action of baclofen GRS 30 mg and 60 mg compared to placebo in subjects with spasticity due to multiple sclerosis.

Duration of effect was assessed using the total modified Ashworth score over time following administration of Baclofen GRS or placebo.

The intent to treat population consisted of 135 subjects. Baclofen GRS did not show a statistically significant improvement in total modified Ashworth score over 24 hours compared to placebo in this study.

An Open Label Extension study (CLR_11_04), consisting of subjects from the efficacy and duration of action studies is ongoing.

"We are disappointed with the outcomes of these studies and will evaluate the data in greater detail to decide on our next steps. We thank all the patients, investigators and caregivers whose hard work has contributed important information to the Baclofen GRS programme", stated Anil Raghavan, CEO, SPARC.