Ironwood Presents New Data on Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old at Digestive Disease Week 2023 - Seite 2

The DDW presentation further showed that efficacy in prespecified age subgroups (6-11 years old and 12-17 years old) was similar, which further supported the primary efficacy findings. Additionally, the presentation at DDW provided more insights on baseline characteristics and safety data:

• Of the 328 patients, 55% were ages 6-11 years-old and 45% were 12-17 years-old at the time of enrollment.
• Demographics and baseline characteristics were similar across linaclotide and placebo-treated groups. At baseline, mean (SD) SBM frequency was similar between study groups (LIN 1.156 (0.828), PBO 1.278 (0.865).
• Both study arms had similar proportions of patients with AEs: TEAEs (LIN, 17%; PBO, 21%), serious AEs (1.2% for both), and TEAEs leading to study treatment discontinuation (LIN, 1.2%, PBO, 1.8%). Treatment-emergent AEs (TEAEs) reported in greater than 2% of patients were diarrhea (LIN, 4.3%; PBO, 1.8%) and COVID-19 (LIN, 2.4%; PBO, 3.0%). One AE of special interest of diarrhea was reported in a 17 year-old.

Linaclotide is marketed as LINZESS by Ironwood and AbbVie in the United States and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). It is not approved for use in patients less than 18 years of age. Ironwood announced earlier this year that the U.S. Food and Drug Administration (FDA) granted priority review to the supplemental New Drug Application (sNDA), which seeks approval of a new indication of linaclotide for functional constipation in pediatric patients aged 6-17 years and assigned a Prescription Drug User Fee Act (PDUFA) date of June 14^th, 2023.

In addition to the primary and secondary efficacy data from the pivotal Phase III study, Ironwood and its collaborators will present other data describing the efficacy of linaclotide in addressing bothersome functional constipation symptoms in pediatric patients ages 6-17 years-old, as well as aggregate data from three studies on the safety profile of linaclotide in this patient population.

“Our data paint a comprehensive picture of the efficacy and safety profile of linaclotide for pediatric patients ages 6-17 with functional constipation,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “We are excited to be sharing our robust pediatric data with the DDW community. Ironwood’s focus on understanding the efficacy and safety of linaclotide in additional patient groups illustrates how we continue to advance our pipeline with the goal to address the significant unmet needs of patients living with GI disorders.”