Live Biotherapeutic Preparation (4D Pharma) in Musculoskeletal Diseases: ACTRN12626000112369 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: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 2
Clinical phase
Not yet recruiting
Recruitment status
80
Planned enrollment
Timing not reported
Primary-completion proxy
Executive view
ACTRN12626000112369 evaluates Live Biotherapeutic Preparation (4D Pharma) in Musculoskeletal Diseases. The disclosed sponsor is Sponsor not reported, 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 ACTRN12626000112369 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Musculoskeletal Diseases landscape. Drug & Asset MCP drug_fetch was queried for Live Biotherapeutic Preparation (4D Pharma), while Company & Deal Intelligence MCP organization_fetch was queried for Sponsor not reported.
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 |
|---|---|---|---|---|---|---|
| ACTRN12626000112369 | Live Biotherapeutic Preparation (4D Pharma) | Phase 2 / Not yet recruiting | Sponsor not reported | Australia | Timing not reported | |
| NCT07389590 | Ublituximab | Phase 4 / Recruiting | The Johns Hopkins University | United States | Proportion of Patients with Wearing-Off From month 1 up to 11 months | 2028-10-01 |
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
ACTRN12626000112369 is a Phase 2, not yet recruiting study with 80 planned participants. Allocation is Randomised controlled trial, masking is Open (masking not used), and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: To evaluate the safety of once daily administration of 2 TDS sizes of MRX-4TZT (32 mg and 40 mg) and 2 dose levels of oral tizanidine (8 mg and 10 mg TID) for 7 days in multiple sclerosis patients with established spasticity.[• The proportion of participants who are withdrawn from oral tizanidine treatment due to safety concerns compared to MRX-4TZT. • The incidence and severity of TEAEs including somnolence, fatigue, dry mouth, asthenia, dizziness, and hypotension bradycardia for oral tizanidine compared to MRX-4TZT. TEAEs will be reported by the participant or observed by the investigator or qualified designee….
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 80 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Tizanidine Hydrochloride as control therapy. 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 Musculoskeletal Diseases. These records do not establish direct evidence for ACTRN12626000112369 unless the registration number matches.
A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffma…
Phase 3; n=1055; Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks From CASTING Baseline to LIBERTO Week 96(Median) = 222.1 weeks (95% Confidence Interval, 222.1 - NA) Source: https://clinicaltrials.gov/ct2/show/results/NCT03599245
Novartis remibrutinib Phase III REMODEL-1/-2 prespecified pooled disability progression analysis
Phase 3; n=not reported; CDP(Prespecified combined analysis) = Positive trend favoring remibrutinib; effect estimate was not disclosed. ; CDP(Prespecified combined analysis) = Positive trend favoring remibrutinib; effect estimate was not disclosed. Source: https://www.biospace.com/press-releases/novartis-remibrutinib-a-high-efficacy-oral-btk-inhibitor-significantly-reduces-relapse-rates-and-shows-favorable-safety-profile-in-phase-iii-rms-trials
A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients…
Phase 3; n=236; Serum Ocrelizumab Area Under the Concentration-Time Curve Over the First 12 Weeks (AUCW1-12) After SC Administration(Mean): Geometric Mean Ratio = 1.2851(90% CI, 1.2258 - 1.3473); Serum Ocrelizumab Area Under the Concentration-Time Curve Over the First 12 Weeks (AUCW1-12) After SC Administration(Mean) = 3500 micrograms/milliliters*day (µg/mL*day) (Standard Deviation, 914) Source: https://clinicaltrials.gov/ct2/show/results/NCT05232825
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
Live Biotherapeutic Preparation (4D Pharma) is indexed as Live biotherapeutic products with target not reported biology and a global stage of Phase 1. The asset profile lists 4D Pharma Plc as an originator or developer.
No exact Company & Deal Intelligence profile was returned for Sponsor not reported. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
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 Live Biotherapeutic Preparation (4D Pharma) 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: ACTRN12626000112369
Protocol source: https://anzctr.org.au/ACTRN12626000112369.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: 28 September 2026.
Live Biotherapeutic Preparation (4D Pharma) in Musculoskeletal Diseases 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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