Serpin Pharma Inc., a clinical-stage biotechnology company developing first-in-class immune-modulating therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SP16 for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). The FDA clearance marks a pivotal regulatory milestone, enabling Serpin Pharma to advance SP16 into clinical evaluation in patients suffering from one of the most debilitating toxicities of cancer therapy.
CIPN affects an estimated 30–40% of patients receiving neurotoxic chemotherapy, often resulting in chronic pain, numbness, tingling, and impaired function that can persist long after treatment ends. There are currently no FDA-approved therapies that prevent or reverse CIPN, representing a critical unmet medical need.
SP16 is a proprietary LRP1-targeting peptide designed to modulate inflammatory and tissue-repair pathways implicated in nerve injury. Preclinical studies suggest that SP16 may reduce pro-inflammatory cytokines while promoting neuroprotective signaling, offering a novel mechanism distinct from existing analgesic or symptomatic approaches.
In September 2025, Serpin Pharma entered into a strategic partnership with Dogwood Therapeutics, Inc. (NASDAQ: DWTX), granting Dogwood a global license to develop and commercialize SP16 for intravenous (IV) administration in cancer patients receiving chemotherapy. Under this agreement, Serpin Pharma continues to lead regulatory activities for the CIPN program while collaborating closely with Dogwood on clinical development.
“FDA clearance of the SP16 IND is a landmark achievement for Serpin Pharma and, most importantly, for patients who urgently need better options,” said Cohava Gelber, PhD, MBA, Chief Executive Officer of Serpin Pharma. “CIPN robs patients of quality of life and often forces dose reductions or discontinuation of life-saving chemotherapy. SP16’s biology gives us real hope that we can intervene at the level of inflammation and nerve repair—not just mask symptoms. We are grateful to the FDA for their thorough review, and our partnership with Dogwood Therapeutics strengthens our ability to bring this therapy to patients as efficiently and effectively as possible.”
The cleared IND includes comprehensive pharmacology, toxicology, and manufacturing data supporting the safety and feasibility of SP16’s intravenous formulation for CIPN. Serpin Pharma now plans to initiate a Phase 1b clinical trial evaluating safety, tolerability, pharmacokinetics, and exploratory biomarkers in patients receiving neurotoxic chemotherapy.
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