AlgoTx's Phase 2 CIPN Trial Shows Promise for ATX01 Despite Placebo Effect Challenges
• AlgoTx completed a 276-patient Phase 2 trial evaluating ATX01, a novel topical treatment for chemotherapy-induced peripheral neuropathy, showing encouraging efficacy signals at 15% concentration.
• The high-concentration ATX01 demonstrated a clinically relevant 1.6-point reduction in pain on the NPRS scale, though overall results were impacted by significant placebo effects at some study sites.
• The non-opioid treatment targeting nociceptive sodium channels showed strong safety profile and promising post-hoc analysis results, supporting further development for addressing the unmet needs of cancer patients.
AlgoTx Completes Phase II Trial of ATX01 for Chemotherapy-Induced Peripheral Neuropathy
• AlgoTx has announced the completion of the Last Patient Last Visit (LPLV) in its Phase II clinical trial, ACT, evaluating ATX01 for chemotherapy-induced peripheral neuropathy (CIPN).
• The international, double-blind, placebo-controlled trial included 276 patients across more than 40 sites in multiple countries.
• ATX01, a topical formulation of amitriptyline, targets nociceptive sodium channels to alleviate pain associated with CIPN, which currently lacks approved treatments.
• The company anticipates sharing the ACT data in early 2025 and plans to expedite a Phase 3 trial for ATX01.
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