M-102.4 ACTRN12625000511437 Clinical Landscape 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

Not yet recruiting

Recruitment status

80

Planned enrollment

Timing not reported

Primary-completion proxy

Executive view

ACTRN12625000511437 evaluates M-102.4 in Neurodegenerative 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 ACTRN12625000511437 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Neurodegenerative Diseases landscape. Drug & Asset MCP drug_fetch was queried for M-102.4, 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
ACTRN12625000511437	M-102.4	Phase 1 / Not yet recruiting	Sponsor not reported	Australia		Timing not reported
NCT07287397	Methylprednisolone	Phase 1/2 / Recruiting	VectorY BV	Netherlands, Belgium, United States, United Kingdom	The number of participants with treatment related adverse events (AEs) and Serious Adverse Events (SAEs) Over 5 years	2027-10-15
NCT07224269	Terazosin Hydrochloride	Early Phase 1 / Recruiting	University of Iowa	United States	Change in ATP levels Baseline and 12 weeks	2027-08-01
NCT07223723	Tofersen	Phase 4 / Active, not recruiting	Biogen, Inc.	China	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Screening up to end of study follow-up (up to 52 weeks)	2027-05-26
NCT07221240	Amisodin	Phase 1 / Recruiting	PRG S&T Co., Ltd	United States	Number and severity of TEAEs following a single oral dose of Amisodin and placebo. From signing of the informed consent form until the follow-up visit (…	2026-05-27

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

ACTRN12625000511437 is a Phase 1, not yet recruiting study with 80 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: Composite outcome assessing the safety and tolerability profile of a single oral dose of M102 over a range of dose exposures in healthy volunteers. [- Incidence and severity of adverse events (TEAEs) will be assessed for severity and causality (relationship of event to the investigational product) by the study investigator using the specified definitions. Common Terminology Criteria for Adverse Events (CTCAE) (V5.0) as 5 grades. - Changes in clinical laboratory parameters including blood tests for hematology. coagulation, serum chemistry, and urinalysis. - Change in vital signs measurements. Vital signs include….

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.

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 Neurodegenerative Diseases. These records do not establish direct evidence for ACTRN12625000511437 unless the registration number matches.

A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral S…

Phase 1/2; n=8; AE = 3 participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05683860

Expansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral Sclerosis

Phase 1; n=3; Number of Participants With Treatment-related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.0) & Medical Dictionary for Regulatory Activities (MedDRA). = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT03241784

Safety and Efficacy of PrimeC in Amyotrophic Lateral Sclerosis

Phase 2; n=68; Drug-related adverse events = 4.3 % ; Drug-related adverse events = 20.0 % Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/41837970/

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

M-102.4 is indexed as Monoclonal antibody with Viral proteins biology and a global stage of Phase 1. The asset profile lists Profectus BioSciences, Inc. 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 M-102.4 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: ACTRN12625000511437
Protocol source: https://anzctr.org.au/ACTRN12625000511437.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.

M-102.4 in Neurodegenerative 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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