SUN-001 in Idiopathic Pulmonary Fibrosis: ACTRN12625000865415 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Recruiting
Recruitment status
64
Planned enrollment
Timing not reported
Primary-completion proxy
Executive view
ACTRN12625000865415 evaluates SUN-001 in Idiopathic Pulmonary Fibrosis. The disclosed sponsor is Sunterra Bio, Inc., the design is Interventional, and the geographic footprint is Australia. The first listed primary endpoint is not reported, assessed over an unreported time frame.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for ACTRN12625000865415 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Idiopathic Pulmonary Fibrosis landscape. Drug & Asset MCP drug_fetch was queried for SUN-001, while Company & Deal Intelligence MCP organization_fetch was queried for Sunterra Bio, Inc..
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| ACTRN12625000865415 | SUN-001 | Phase 1 / Recruiting | Sunterra Bio, Inc. | Australia | Timing not reported | |
| NCT07201922 | Nerandomilast | Phase 3 / Recruiting | Boehringer Ingelheim GmbH | Canada, South Korea, Netherlands, Argentina, Belgium, United States, Japan, United Kingdom, Italy, France, Australia, Germany, Spain | Time to physiologic or radiologic worsening of ILA/ILD over the whole trial up to 164 weeks | 2029-05-14 |
| NCT07194382 | Nintedanib esylate | Phase 2 / Recruiting | Avalyn Pharma, Inc. | New Zealand, Canada, United Kingdom, Australia, Germany, Spain | Change from baseline in the morning pre-dose forced vital capacity at Week 12 From enrollment to the end of treatment at 12 weeks | 2026-12-01 |
| NCT07192939 | HRS-9813 | Phase 2 / Recruiting | Guangdong Hengrui Pharmaceutical Co., Ltd. | China | FVC as a percentage of the predicted value The baseline period lasted until 26weeks after administration | 2028-06-01 |
| NCT07179380 | Treprostinil palmitil | Phase 3 / Recruiting | Insmed, Inc. | Czechia, United States, Malaysia, Portugal, Greece, South Korea, Austria, Turkey, Brazil, Serbia, France, Argentina, Romania, Philippines, Japan, United Kingdom, Switzerland, Spain, New Zealand, Belgium, Taiwan Province, Denmark, Italy, Israel, Australia, Germany | Change in 6MWD Measured at Peak Exposure From Baseline to Week 24 Baseline, Week 24 | 2028-12-30 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
ACTRN12625000865415 is a Phase 1, recruiting study with 64 planned participants. Allocation is Randomised controlled trial, masking is Blinded (masking used), and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: To assess the safety and tolerability of SUN-001 following inhaled administration of single and multiple ascending doses.[Safety and tolerability will be assessed by the incidence and severity of all treatment emergent adverse events (TEAEs). Safety and tolerability will be assessed by the incidence and severity of all treatment emergent adverse events (TEAEs), collected and evaluated at each visit from the time of Investigational Medicinal Product (IMP) administration until the final follow-up visit on Day 28 (27 days post first dose for Part A) or Day 44 (41 to 43 days post first dose for Part B)];To assess th….
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 64 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Idiopathic Pulmonary Fibrosis. These records do not establish direct evidence for ACTRN12625000865415 unless the registration number matches.
A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosi…
Phase 2; n=320; Change From Baseline in Forced Vital Capacity at Week 52(Mean) = 38.0 mL (Standard Deviation, NA); Change From Baseline in Forced Vital Capacity at Week 52(Mean) = 176.0 mL (Standard Deviation, NA) Source: https://clinicaltrials.gov/ct2/show/results/NCT06097260
Deupirfenidone compared with pirfenidone and placebo in idiopathic pulmonary fibrosis (ELEVATE-IPF): a phase 2b randomized placebo-controlled trial
Phase 2; n=257; FVC(change in) = -110.71 mL ( -148.75 to -70.98); FVC(change in) = -48.42 mL ( -87.66 to -9.04) Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42085224/
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis
Phase 3; n=593; FVC = -136.4 ml ( -172.5 to -104.0); FVC = -49.9 ml ( -79.2 to -19.5) Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/41812190/
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
SUN-001 is indexed as Small molecule drug with target not reported biology and a global stage of Phase 1. The asset profile lists Sunterra Bio, Inc. as an originator or developer.
Sunterra Bio, Inc. is indexed in United States with the website http://sunterrabio.com. Developing novel inhaled small molecules for rare respiratory diseases The record lists 1 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether SUN-001 is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: ACTRN12625000865415
Protocol source: https://anzctr.org.au/ACTRN12625000865415.aspx
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.
SUN-001 in Idiopathic Pulmonary Fibrosis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and Timing not reported the leading decision points.
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