Boehringer Ingelheim Reports Positive Phase II Results for Apecotrep in Primary FSGS
Boehringer Ingelheim has reported positive results from a 12-week Phase II clinical trial evaluating apecotrep (BI 764198), an oral, potential first-in-class, non-immunosuppressive TRPC6 inhibitor for people with primary focal segmental glomerulosclerosis (FSGS).
The study showed that apecotrep reduced proteinuria by 40% versus placebo in the 20 mg dose group, a key marker linked to kidney damage.
The findings were published in The Lancet and presented at ASN Kidney Week 2025.
Why this matters for primary FSGS?
Primary FSGS is a rare and progressive kidney disease that can lead to kidney failure.
There are no approved targeted or disease-modifying therapies today.
Key challenges include:
- High risk of progression to end-stage kidney disease
- Limited treatment options beyond supportive care
- Significant impact on children and adults
Apecotrep aims to address the underlying disease mechanism, not just symptoms.
How apecotrep works?
In primary FSGS, the TRPC6 protein channel is thought to be overactivated on podocytes.
This overactivation:
- Allows excessive calcium into podocytes
- Leads to podocyte injury and loss
- Drives proteinuria and disease progression
Apecotrep is designed to inhibit TRPC6, protect podocytes, and slow kidney damage.
Key Phase II trial results
After 12 weeks of treatment:
- 35% of patients on apecotrep achieved ≥25% reduction in UPCR
- 7.1% of patients in the placebo group achieved this response
- Highest response rate seen with the 20 mg dose (44.4%)
- 40% reduction in UPCR versus placebo with 20 mg (p=0.0024)
- Apecotrep was generally well tolerated
Next steps in development
- Phase III trial (NCT07220083) is recruiting adults and adolescents with primary FSGS
- Additional Phase II trial (NCT07355296) will start in Q1 to study apecotrep in other proteinuric kidney diseases
Regulatory recognition
Apecotrep has received:
- Breakthrough Therapy Designation from China’s CDE
- Orphan Drug Designation from the EMA
- Orphan Drug Designation from Japan’s MHLW
What Boehringer is saying?
Paola Casarosa, Head of Innovation Unit, Boehringer Ingelheim:
With the Phase III trial now underway, we are advancing apecotrep driven by the potential to deliver the first disease-modifying treatment for primary FSGS and redefine the standard of care.
Howard Trachtman, University of Michigan:
These findings reinforce the importance of further investigation of apecotrep as a first-in-class targeted treatment for primary FSGS, where unmet need remains high.
About primary FSGS
- A podocyte-driven kidney disease causing proteinuria
- Around 50% progress to ESKD within 5–10 years
- Leading cause of nephrotic syndrome in adults
- Global prevalence up to 0.8 per 100,000 people
About apecotrep (BI 764198)
- Oral, once-daily, non-immunosuppressive TRPC6 inhibitor
- Part of Boehringer Ingelheim’s Cardiovascular-Renal-Metabolic portfolio
- Discovered and developed in-house
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