SDE - 124 is a long acting, sub cutaneous injection of the one of the most prescribed GLP-1 receptor agonists. Existing treatment has huge injection burden per year leading to inadequate compliance and adversely affecting patient outcomes. In order to overcome this issue, SPARC has developed a long acting subcutaneous injection for self-administration which reduces needle burden significantly ensuring patient acceptability.
The formulation is in the form of a gel that utilizes intrinsic gelling property of the active ingredient and excipients. Designed with primary focus on patients, SDE-124 has been optimized for ease of injection and desired duration. The drug release occurs by slow erosion from the site of administration. This patented technology allows for tuning of delivery rate and duration of treatment.
SPARC was able to establish preclinical proof of concept in more than one animal models where reduction of HbA1C was comparable or better than the marketed reference formulations and target therapeutic concentration was maintained for the desired duration.
FDA’s response to pre-IND meeting request confirms that SDE-124 would be subject to the 505 (b) 2 approval pathway. The FDA’s response provides SPARC significant optimism for immediately pushing forward IND enabling activities towards Phase I early proof of concept studies in human. We are planning to initiate the study by Q4 FY20.
*Extrapolated to expected human equivalent dose,
Two way ANOVA followed by Bonferroni post test, ***p<0.001 as compared to Placebo, $$p<0.01 as compared to Trulicity SD rats = Sprague Daeley rats SC = Sub-cutaneos