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
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.
Indication: Amyotrophic Lateral Sclerosis
Modality: small molecule
Target: SPG302 is a synthetic small molecule targeting mechanisms associated with neurodegeneration in Amyotrophic Lateral Sclerosis (ALS).
Sponsor: Spinogenix
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 03, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: SPG302 is a synthetic small molecule targeting mechanisms associated with neurodegeneration in Amyotrophic Lateral Sclerosis (ALS).
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Condition raw: Amyotrophic Lateral Sclerosis
Condition normalized: Amyotrophic Lateral Sclerosis
Modality raw: small molecule
Modality normalized: small molecule
Target raw: SPG302 is a synthetic small molecule targeting mechanisms associated with neurodegeneration in Amyotrophic Lateral Sclerosis (ALS).
Target normalized: SPG302 is a synthetic small molecule targeting mechanisms associated with neurodegeneration in Amyotrophic Lateral Sclerosis (ALS).