TrialSignal
Clinical trial intelligence report
A Phase 1/2a, Randomized, Double Blind, Placebo Controlled, Single and Multiple Dose Escalation Study in Healthy Volunteers and an Expansion Cohort in Adult Participants With Amyotrophic Lateral Sclerosis (ALS) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT05882695-Jul 28, 2026
NCT ID
NCT05882695
Status
COMPLETED
Phase
Phase 1/2a
Sponsor
Spinogenix
Executive brief
Investment-Ready Snapshot
Spinogenix is advancing SPG302 through a Phase 1/2a clinical trial aimed at assessing its safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy volunteers and ALS patients. The ALS market is characterized by a high unmet need, with limited effective therapies currently available. Successful outcomes from this trial could position SPG302 as a novel treatment option, potentially capturing significant market share in a competitive landscape dominated by established therapies such as Riluzole and Edaravone. The collaboration with Novotech for trial execution enhances operational capabilities, while the completion of the trial by mid-2025 aligns with strategic timelines for potential market entry. Diligence should focus on the robustness of safety data and the drug's mechanism of action to ensure differentiation from existing therapies.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT05882695
Indication
Amyotrophic Lateral Sclerosis
Modality
small molecule
Target
SPG302 is a synthetic small molecule targeting mechanisms associated with neurodegeneration in Amyotrophic Lateral Sclerosis (ALS).
Intervention
SPG302, Placebo
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.