Dogwood Therapeutics (Nasdaq: DWTX) announced that the US FDA has accepted an investigational new drug (IND) application for SP16, an intravenously administered LRP1 agonist licensed from Serpin Pharma, for the treatment of chemotherapy-induced peripheral pain and neuropathy. Serpin Pharma holds the IND and serves as regulatory sponsor; Dogwood secured a royalty-free global license to develop and commercialize the IV formulation in September 2025.
Chemotherapy-induced peripheral neuropathy affects an estimated 30%–40% of patients six months after receiving neurotoxic regimens, with platinum- and taxane-based drugs carrying the highest risk. Symptoms — numbness, tingling, pain, and impaired motor function — can persist long after treatment ends and directly affect functional capacity in cancer survivors. Despite the prevalence of the condition, no drug carries an FDA approval specifically for this indication. Duloxetine, an SNRI approved for diabetic peripheral neuropathic pain, is recommended off-label by the American Society of Clinical Oncology based on a single Phase III trial showing modest benefit; gabapentin and pregabalin are used in practice without guideline endorsement for this setting. The absence of an approved therapy means SP16, if it advances, would enter a regulatory vacancy rather than a crowded market.
SP16 is described by the company as an LRP1 agonist that confers alpha-1-antitrypsin-like activity. Preclinical data, according to Dogwood, show two proposed mechanisms: suppression of pro-inflammatory cytokines including IL-6, IL-8, IL-1β, and TNF-α, and activation of pAKT and pERK signaling pathways associated with cell growth, proliferation, and survival. The company frames this dual action as both analgesic and potentially neuro-reparative — a mechanistic profile that differs from all agents currently used in the CIPN setting, none of which target the neuroinflammatory cascade or promote structural nerve repair. Those claims remain preclinical, and the forthcoming Phase Ib trial will be the first test of the mechanism in patients with CIPN.
The Phase Ib trial is expected to begin enrolling patients at the University of Virginia in mid-2026. It is fully funded by a USD 2.5 million grant from the National Cancer Institute awarded to Serpin Pharma, which lends institutional backing to the programme without drawing on Dogwood's own capital.