Regulatory & Policy

FDA accepts Dogwood Therapeutics' SP16 IND application for chemotherapy-induced pain and neuropathy

Edited by Robert McTiernan··2 min read

Dogwood Therapeutics announced that the US FDA has accepted an Investigational New Drug (IND) application for SP16, an intravenously administered low-density lipoprotein receptor-related protein-1 (LRP1) agonist, for the treatment of chemotherapy-induced pain and peripheral neuropathy (CIPPN). The filing marks the first time SP16 has entered formal US clinical development, with Serpin Pharma holding the IND as regulatory sponsor. The company licensed the asset from Serpin Pharma in September 2025 under a royalty-free global agreement.

The IND acceptance clears the path for a Phase Ib trial in patients with CIPPN, with enrollment expected to begin in mid-2026 at the University of Virginia. The study is fully funded by a USD 2.5 million grant from the National Cancer Institute.

SP16 is proposed to act through two mechanisms: anti-inflammatory activity via reductions in IL-6, IL-8, IL-1β, and TNF-alpha, and tissue repair signaling through increases in pAKT and pERK. The company describes these as hypothesized actions, and the available evidence supporting them is preclinical. No human efficacy or safety data have been reported.

The IND acceptance positions SP16 as Dogwood's second candidate in active clinical development for chemotherapy-related neuropathy. The company's lead asset, Halneuron, a NaV1.7 voltage-gated sodium channel modulator, holds FDA Fast Track designation for chemotherapy-induced neuropathic pain and is currently in Phase 2b development. The two programs target overlapping but distinct aspects of the CIPPN symptom burden, with SP16 described as addressing numbness, tingling, and impaired motor function alongside pain.

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CIPPN affects approximately 30%–40% of patients six months after receiving neurotoxic chemotherapy, according to the company's announcement, and can persist long-term. Risk factors include the use of platinum- or taxane-containing regimens, higher cumulative doses, and underlying diabetes. The condition remains one of the more poorly managed complications in oncology supportive care, in part because no drug has received FDA marketing approval specifically for its prevention or treatment.

The only agent with any guideline support in this setting is duloxetine, an SNRI used off-label for painful CIPPN. The 2020 ASCO guideline update described its benefit as limited, and agents such as gabapentin, pregabalin, and tricyclic antidepressants have not demonstrated efficacy in CIPPN-specific randomised trials. In January 2025, the US FDA published draft guidance for industry on developing drugs for CIPPN, a signal of growing regulatory attention to the indication but not itself an approval pathway change.

The SP16 program joins a small number of assets in early clinical development for CIPPN. Artelo Biosciences has received IND clearance for ART26.12, a selective FABP5 inhibitor, also in Phase I. The field remains at an early stage, with no candidate yet having generated Phase II or Phase III data in CIPPN. The mechanistic diversity of programs entering the clinic — LRP1 agonism, sodium channel modulation, FABP5 inhibition — reflects an absence of consensus on the optimal therapeutic target in this condition.

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