LY-N001(Lingyi (Hangzhou) Biotechnology) in Parkinson Disease: NCT07685444 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.
Early Phase 1
Clinical phase
Not yet recruiting
Recruitment status
18
Planned enrollment
2028-07-07
Primary-completion proxy
Executive view
NCT07685444 evaluates LY-N001(Lingyi (Hangzhou) Biotechnology) in Parkinson Disease. The disclosed sponsor is Lingyi (Hangzhou) Biotechnology Co., Ltd., the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Incidence of dose-limiting toxicity (DLT) events occurring within at least 28 days following a single intracranial administration of LY-N001, assessed over Within 28 days post-administration.
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 NCT07685444 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Parkinson Disease landscape. Drug & Asset MCP drug_fetch was queried for LY-N001(Lingyi (Hangzhou) Biotechnology), while Company & Deal Intelligence MCP organization_fetch was queried for Lingyi (Hangzhou) Biotechnology Co., Ltd..
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 |
|---|---|---|---|---|---|---|
| NCT07685444 | LY-N001(Lingyi (Hangzhou) Biotechnology) | Early Phase 1 / Not yet recruiting | Lingyi (Hangzhou) Biotechnology Co., Ltd. | China | Incidence of dose-limiting toxicity (DLT) events occurring within at least 28 days following a single intracranial admi… Within 28 days post-administration | 2028-07-07 |
| ACTRN12626000769381 | Levodopa hydrate | Phase 1 / Not yet recruiting | University of Edith Cowan | Australia | Timing not reported | |
| ACTRN12626000740392 | Probucol | Phase 2 / Not yet recruiting | Curtin University | Australia | Timing not reported | |
| NCT07647913 | Levodopa hydrate | Not Applicable / Not yet recruiting | McMaster University | Canada | Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks. Between experimental sessions one and two, which will take place appr… | 2027-09-30 |
| NCT07640542 | [11C]MODAG 005 | Early Phase 1 / Not yet recruiting | MODAG GmbH | Germany | Safety and Tolerability Inclusion to 4 days (± 2 days) post injection. | 2027-07-01 |
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
NCT07685444 is a Early Phase 1, not yet recruiting study with 18 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment.
The primary endpoint is “Incidence of dose-limiting toxicity (DLT) events occurring within at least 28 days following a single intracranial administration of LY-N001” over “Within 28 days post-administration.” The retrieved endpoint description is: DLT events will be assessed per CTCAE Version 6.0..
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 18 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 Parkinson Disease. These records do not establish direct evidence for NCT07685444 unless the registration number matches.
Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study
Phase 2; n=12; 7 days following first drug dose(Mean) = 56.455 Total score (Standard Deviation, 19.154) Source: https://clinicaltrials.gov/ct2/show/results/NCT04932434
A Randomized, Double-blind, Placebo-controlled Trial of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
Phase 2; n=45; Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compared Between Each Active MSC Dose Arm and Placebo(Mean) = 94.4 percentage of participants (95% Confidence Interval, 74.7 - 99.7); Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compare… Source: https://clinicaltrials.gov/ct2/show/results/NCT04506073
Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
Early Phase 1; n=31; Augmentation Index(Mean) = 30 Percentage (Standard Deviation, 25); Augmentation Index(Mean) = -20 Percentage (Standard Deviation, 7) Source: https://clinicaltrials.gov/ct2/show/results/NCT04620382
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
LY-N001(Lingyi (Hangzhou) Biotechnology) is indexed as AAV based gene therapy with GBA1 biology and a global stage of Early Phase 1. The asset profile lists Lingyi (Hangzhou) Biotechnology Co., Ltd. as an originator or developer.
Lingyi (Hangzhou) Biotechnology Co., Ltd. is indexed in China with the website http://www.lingyimed.com. Lingyi Bio is a rare disease animal model functional verification platform and gene therapy developer. The record lists 7 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 LY-N001(Lingyi (Hangzhou) Biotechnology) 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: NCT07685444
Protocol source: https://clinicaltrials.gov/study/NCT07685444
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.
LY-N001(Lingyi (Hangzhou) Biotechnology) in Parkinson Disease is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence of dose-limiting toxicity (DLT) events occurring within at least 28 days following a single intracranial administration of LY-N001 and 2028-07-07 the leading decision points.
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