1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Ironwood Hits Phase III Endpoint In SBS-IF, But Shareholders Show Wariness

 
• By Joseph Haas

Looking to compete with Takeda’s Gattex in short bowel syndrome with intestinal failure, Ironwood succeeds in a Phase III trial, but investors may be concerned with misses on secondary endpoints.

Ironwood's Phase III trial will lead to an FDA filing in SBS-IF

Ironwood Pharmaceuticals, Inc. appears to have a clear difference of opinion with shareholders after reporting Phase III data for short bowel syndrome with intestinal failure (SBS-IF) candidate apraglutide on 29 February that were positive, but nevertheless resulted in the Boston-based firm’s stock price cratering by 38% to $9.43 per share.

In an interview, Ironwood chief medical officer Michael Shetzline said he thinks there is a basic misunderstanding about the results from the trial, which hit its primary endpoint and two key secondary endpoints, while missing a pair of secondary endpoints in a patient subset, those with colon-in-continuity (CIC)

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

More from R&D

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 
• By Sushmita Panda

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.