NI-005 NCT05039099 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: 16 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 2

Clinical phase

Completed

Recruitment status

not reported

Planned enrollment

2025-08-13

Primary-completion proxy

Executive view

NCT05039099 evaluates NI-005 in Amyotrophic Lateral Sclerosis. The disclosed sponsor is AL-S Pharma AG, the design is Interventional, and the geographic footprint is Canada, Sweden, South Korea, Belgium, United States, Germany. The first listed primary endpoint is Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (TESAE) During the Double-Blind Period, assessed over From the first dose through the 21-day follow-up after Week 24, approximately 27 weeks.

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 NCT05039099 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Amyotrophic Lateral Sclerosis landscape. Drug & Asset MCP drug_fetch was queried for NI-005, while Company & Deal Intelligence MCP organization_fetch was queried for AL-S Pharma AG.

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
NCT05039099	NI-005	Phase 2 / Completed	AL-S Pharma AG	Canada, Sweden, South Korea, Belgium, United States, Germany	Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (TESAE) During… From the first dose through the 21-day follow-up after Week 24, appro…	2025-08-13
NCT05797701	Oditrasertib	Phase 1 / Completed	Sanofi	United States	Part 1: Maximum plasma concentration observed (Cmax) In both Period 1 and Period 2: From Day 1 to Day 3	2021-09-06
NCT05797753	Itraconazole	Phase 1 / Completed	Sanofi	United States	Part A: SAR443820: Area under the plasma concentration from time zero to the last concentration above the limit of quan… Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10	2022-07-01
NCT05795907	Oditrasertib	Phase 1 / Completed	Sanofi	United States	Parts 1a and 1b: Number of participants with adverse events Day1 up to Day 7 (end of study visit)	2021-07-20
NCT05753852	Tauroursodeoxycholate sodium	Phase 3 / Unknown status	Humanitas Mirasole SpA	Netherlands, Belgium, Ireland, United Kingdom, Italy, France, Germany	Long-term safety and tolerability of TUDCA during the open-label phase 18 months	2025-03-31

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

NCT05039099 is a Phase 2, completed study with not reported planned participants. Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment.

The primary endpoint is “Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (TESAE) During the Double-Blind Period” over “From the first dose through the 21-day follow-up after Week 24, approximately 27 weeks.” The retrieved endpoint description is: Treatment-emergent adverse events were adverse events that began or worsened after the first dose of randomized study treatment during the double-blind period. Treatment-emergent serious adverse events met the protocol-defined criteria for seriousness. Participants experiencing more than one event within a category were counted once in that category. Results are presented separately for the sporadic ALS and SOD1-associated ALS cohorts..

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 not reported 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

0 recent result records were selected as contextual evidence for Amyotrophic Lateral Sclerosis. These records do not establish direct evidence for NCT05039099 unless the registration number matches.

Indexed evidence status

No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.

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

NI-005 is indexed as Monoclonal antibody with SOD1 biology and a global stage of Phase 2. The asset profile lists AL-S Pharma AG as an originator or developer.

AL-S Pharma AG is indexed in an unreported country with the website http://www.al-spharma.com. AL-S Pharma AG develops AP-101, a human monoclonal antibody targeting misfolded SOD1 for the treatment of ALS. The record lists 2 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 NI-005 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: NCT05039099
Protocol source: https://clinicaltrials.gov/study/NCT05039099
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: 16 October 2026.

NI-005 in Amyotrophic Lateral Sclerosis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (TESAE) During the Double-Blind Period and 2025-08-13 the leading decision points.

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