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Clinical Development and Trials  

Asengeprast is a novel, orally administered small‑molecule designed to modulate key pathways involved in fibrosis.

Certa has completed Phase 1 and Phase 2a clinical studies supporting the safety, tolerability, and pharmacokinetic profile of asengeprast in healthy participants and patients with diabetic nephropathy and diffuse systemic sclerosis (dSSc).

Lead Clinical Program Phase 1 Clinical Studies

Lead Clinical Program 

Diffuse Systemic Sclerosis (Scleroderma) 

study design

In a Phase 2a, randomised, double-blind, placebo‑controlled clinical trial, patients with dSSc received once‑daily oral dosing of 0, 200 mg or 400 mg for an initial period of three months (NCT04647890). Following completion of the primary study phase, three patients continued to receive asengeprast (200 or 400mg) in an open‑label extension for up to an additional 21 months. 

key findings

Safety & Tolerability

The compound was safe and well tolerated across all dose levels. 

  • No treatment‑related serious adverse events were reported 
  • No deaths, study withdrawals, interruptions, or discontinuations due to treatment 
  • Safety findings supported continuous once‑daily oral dosing 

Clinical Effect

While exploratory in nature, data from this study suggests that asengeprast treatment may have some clinical benefit in dSSc patients:

  • Patients receiving the 400 mg dose showed the highest responder rate (60%) using ACR‑CRISS criteria compared to 10% in the placebo group 
  • Post‑hoc analysis applying CRISS‑25 criteria identified an 80% responder rate in the 400 mg group, compared with 10% in the placebo group 
  • Symptom worsening was observed in 30% of placebo‑treated patients versus 0% in the 400 mg group 
  • Transcriptomic analysis of patient skin biopsies demonstrated a reversal in the activation of fibrosis‑associated genetic markers following treatment with Asengeprast. 

Taken together, these results support further investigation of asengeprast in fibrotic diseases.

Phase 1 Clinical Studies 

Healthy Participants and Diabetic Nephropathy 

Certa has completed Phase 1 single‑ascending dose (SAD) and multiple‑ascending dose (MAD) studies evaluating safety, tolerability, and pharmacokinetics of asengeprast in both healthy volunteers and patients with diabetic nephropathy (DN) (ACTRN12613000386730).

study design

  • Healthy Volunteers
    • Single‑ascending doses up to 100 mg
    • Multiple‑ascending doses up to 500 mg 

  • Diabetic Nephropathy
    • Multiple‑dose administration in patients with DN, selected to assess safety in a population relevant to fibrotic pathology (100 or 250 mg daily dose) 

key findings

Asengeprast was safe and well tolerated across all cohorts 

No dose‑limiting toxicities were observed 

The safety profile supported repeat dosing and the feasibility of chronic administration 

The plasma and urinary pharmacokinetic profile of asengeprast was defined to support dose selection for future clinical studies 

Program Overview

  • Modality: Oral small molecule 
  • Dosing: Once daily 
  • Therapeutic Focus: Fibrosis‑associated pathways 
  • Clinical Stage: Completed Phase 1 and Phase 2a studies 
  • Differentiation: Oral administration, long‑term dosing data, and early clinical signals in fibrotic diseases 


The existing package supports further clinical development of asengeprast, and provides a strong basis for collaboration across clinical, scientific, and strategic partners. 

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