First anti-stricture therapy and fast track designation by the FDA

[Soryan]

https://www.biospace.com/article/re...e-and-starts-stenova-phase-2a-clinical-trial/

Fibrotic strictures develop in nearly 50% of patients living with Crohn’s disease and remain a major therapeutic challenge as strictures are the main cause for bowel surgery, an outcome which occurs in approximately 75% of Crohn’s disease patients. The TGF-β pathway is a key driver of fibrosis in the GI tract, and inhibition through its receptor ALK5 is considered the most effective therapeutic approach to block it.

AGMB-129 is the first drug candidate to receive FDA Fast Track Designation for the treatment of Fibrostenosing Crohn’s Disease.

Sounds like exciting news. What are your thoughts on this?

 

[Pilgrim]

I've never seen the 75% stricture outcome stat. That's discouraging. Glad there is a proposed treatment.

 

[my little penguin]

@Pilgrim it’s 50% stricture and 75% surgery.
But those numbers were before biologics were used or only used as a last resort .

Abstract
Background and Aims
Inflammatory bowel disease (IBD) can lead to long-term complications that significantly impact patients’ quality of life and healthcare resource utilization. Prior studies have demonstrated improved short-term outcomes to early exposure of biologics in patients with Crohn’s disease (CD) but not in patients with ulcerative colitis (UC). However, there are conflicting data on impact of early intervention on longer-term adverse events. Therefore, we conducted a systematic review and meta-analysis assessing the impact of early biologic treatment on rates of IBD-related surgery.
Methods
A systematic search was conducted in April 2022. Studies were included if biologic initiation was compared between patients starting early (<3 years of diagnosis or top-down treatment) vs later (>3 years of diagnosis or step-up treatment). Studies with <1 year of follow-up were excluded. The outcomes were colectomy and CD-related surgery for patients with UC and CD, respectively. Random-effects analyses were conducted to compare rates of IBD surgery between early and late biologic treatment.
Results
Eighteen studies were included in the meta-analysis. Three studies included patients with UC and 15 studies included patients with CD. In patients with CD, early biologic therapy was associated with lower odds of surgery (odds ratio, 0.63; 95% confidence interval, 0.48-0.84) compared with late treatment. Conversely, in patients with UC, the odds of colectomy were increased (odds ratio, 2.86; 95% confidence interval, 1.30-6.30).
Conclusions
Early biologic treatment is associated with lower rates of surgery in patients with CD. In contrast, early biologic therapy appears to be associated with higher rates of colectomy in patients with UC, which may be confounded by disease severity.

from

https://academic.oup.com/ibdjournal.../ibd/izad149/7233305?redirectedFrom=fulltext#

 

[Pilgrim]

@my little penguin Thanks for the clarification! That makes more sense to me.