- 4D pharma plc LBPS has announced additional positive data from its completed Phase 2 trial of LBP Blautix in subjects with irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D).
- The data has been presented at Digestive Disease Week (DDW).
- The company previously announced topline efficacy and safety results from the trial in October 2020.
- Further analysis of the data has revealed strong and statistically significant activity on the key symptom of bowel habit, a potential approvable primary endpoint per regulatory guidelines.
- Additional efficacy data comes from the post-hoc subgroup analysis in evaluable patients (IBS-C, N=147; IBS-D N=169).
- Blautix demonstrated statistically significant improvements in bowel habit in IBS-D (Blautix 62.0% vs placebo 47.4%, p=0.042), and a strong effect nearing significance in IBS-C (Blautix 53.8% vs placebo 39.3%, p=0.054).
- Patients receiving Blautix reported progressive decreases in abdominal pain intensity over the treatment period.
- After eight weeks of treatment, evaluable IBS-C and IBS-D patients receiving Blautix reported an average decrease from baseline in weekly abdominal pain scores of 29.7% and 34.4%, respectively.
- In evaluable U.S. patients, Blautix demonstrated a more than two-fold greater ORR than placebo in IBS-D (Blautix 29.3% vs. placebo 14.3%, p=0.07), and a clinically meaningful 73% improvement in ORR over placebo in IBS-C (Blautix 28.3% vs. placebo 16.4%, p=0.096).
- As previously reported, Blautix demonstrated a safety profile comparable to placebo, with no treatment-related severe adverse events or serious adverse events.
- The company continues to evaluate the Blautix Phase 2 data and plans to engage in regulatory discussions in the second half of 2021.
- The company will host a virtual event to review the additional data tomorrow at 12 P.M E.T.
- Price Action: LBPS shares are up 6.97% at 11.81 during the premarket session on the last check Monday.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
