AMX-0114 in Amyotrophic Lateral Sclerosis: NCT06665165 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: 15 October 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
not reported
Planned enrollment
2027-02-01
Primary-completion proxy
Executive view
NCT06665165 evaluates AMX-0114 in Amyotrophic Lateral Sclerosis. The disclosed sponsor is Amylyx Pharmaceuticals, Inc., the design is Interventional, and the geographic footprint is Canada, United States. The first listed primary endpoint is Evaluate the safety and tolerability of AMX0114 in adult participants living with ALS, assessed over Day 1 - Day 145 (End of Study).
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 NCT06665165 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 AMX-0114, while Company & Deal Intelligence MCP organization_fetch was queried for Amylyx Pharmaceuticals, 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 |
|---|---|---|---|---|---|---|
| NCT06665165 | AMX-0114 | Phase 1 / Recruiting | Amylyx Pharmaceuticals, Inc. | Canada, United States | Evaluate the safety and tolerability of AMX0114 in adult participants living with ALS Day 1 - Day 145 (End of Study) | 2027-02-01 |
| NCT06658977 | Abacavir sulfate/Dolutegravir sodium/Lamivudine | Phase 3 / Terminated | Macquarie University | Australia | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). Duration of the study plus 7 days | 2025-06-03 |
| NCT06656702 | Psilocybin | Early Phase 1 / Recruiting | The Johns Hopkins University | United States | Feasibility of psilocybin treatment as assessed by number of participants recruited, retained and adhere to treatment 6 months | 2027-01-30 |
| NCT06643481 | VHB937 | Phase 2 / Status not reported | Novartis Pharmaceuticals | United States, United Kingdom, Switzerland, Spain, Canada, Sweden, South Korea, Netherlands, Belgium, Ireland, China, Poland, Denmark, Italy, France, Australia, Germany | The composite of PAV-free survival and change in ALSFRS-R. Analysis method: Combined Assessment of Function and Surviva… Baseline to DB Week 40 | 2026-06-23 |
| NCT06645197 | SG-001 (SineuGene) | Early Phase 1 / Not yet recruiting | Peking University Third Hospital | China | To evaluate the safety and tolerability of ascending doses of intrathecally administered SNUG01 in Participants with ALS Each visit in 1 year after administration | 2025-04-15 |
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
NCT06665165 is a Phase 1, recruiting study with not reported planned participants. Allocation is Randomized, masking is Quadruple, and the intervention model is Sequential Assignment.
The primary endpoint is “Evaluate the safety and tolerability of AMX0114 in adult participants living with ALS” over “Day 1 - Day 145 (End of Study).” The retrieved endpoint description is: Incidence of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs). Incidence of abnormalities in clinical laboratory assessments, vital signs, physical and neurological examinations, and electrocardiograms (ECGs)..
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 NCT06665165 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
AMX-0114 is indexed as ASO with CAPN2 biology and a global stage of Phase 1. The asset profile lists Amylyx Pharmaceuticals, Inc. as an originator or developer.
Amylyx Pharmaceuticals, Inc. is indexed in an unreported country with the website http://www.amylyx.com. Amylyx Pharmaceuticals specializes in providing solutions for Alzheimer’s and other diseases of the brain. The record lists 9 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 AMX-0114 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: NCT06665165
Protocol source: https://clinicaltrials.gov/study/NCT06665165
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: 15 October 2026.
AMX-0114 in Amyotrophic Lateral Sclerosis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Evaluate the safety and tolerability of AMX0114 in adult participants living with ALS and 2027-02-01 the leading decision points.
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