NCT07601295 Tiprelestat(Proteo Biotech AG) Pulmonary Arterial Hypertension Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07601295 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07601295 is a hot trial to watch
Pulmonary Arterial Hypertension is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07601295 is notable because it evaluates Tiprelestat(Proteo Biotech AG) in a Phase 2 design sponsored by Stanford University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07601295 |
| Official title | Tiprelestat Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) (ATHENA) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Tiprelestat(Proteo Biotech AG) |
| Sponsor | Stanford University |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Change in Pulmonary Vascular Resistance (PVR) |
| Endpoint time frame | Baseline to week 24 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The primary objective of this study is to compare the efficacy, safety, and tolerability of tiprelestat plus Standard of Care (SOC) compared with placebo plus SOC in patients with World Health Organization (WHO) functional class II-IV pulmonary arterial hypertension (PAH).
Allocation is Randomized, masking is Triple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Change in Pulmonary Vascular Resistance (PVR) (Baseline to week 24) — PVR is calculated based on direct measurements during the right heart catheterization (RHC) procedure. PVR = (mPAP - PAWP) / CO, where mPAP is the mean pulmonary artery pressure, PAWP is the pulmonary wedge arterial pressure, and CO is the cardiac output. These cardiac measures are also obtained from right heart catheterization. PVR is measured in Wood units (WU) or dynes (dynes\*sec/cm5), and higher values are assoc
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Tiprelestat(Proteo Biotech AG) is indexed as Recombinant protein, with target ELA2 x PRTN3, mechanism ELA2 inhibitors, Leukocyte proteinase 3 inhibitors, Pancreatic elastase inhibitors, and global highest development status Phase 2.
Company & Deal Intelligence MCP profile: Stanford University is resolved to a normalized organization record in SANTA CLARA COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07601295 provides a focused lens on Pulmonary Arterial Hypertension development. Its value will be determined by whether Tiprelestat(Proteo Biotech AG) can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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