Dogwood Therapeutics received FDA acceptance of its Investigational New Drug application for SP16 on April 15, 2026, allowing the company to begin enrolling patients in a Phase 1b trial.
The trial, fully funded by a $2.5 million National Cancer Institute grant awarded to Serpin Pharma, will start mid‑2026 at the University of Virginia and will evaluate SP16’s anti‑inflammatory and nerve‑repair effects in patients with chemotherapy‑induced peripheral neuropathy.
SP16 is a low‑density lipoprotein receptor‑related protein‑1 agonist that mimics alpha‑1‑antitrypsin, targeting inflammatory cytokines and promoting nerve repair. The FDA acceptance marks a critical regulatory milestone for the drug and for Dogwood’s pipeline.
The acceptance expands Dogwood’s portfolio beyond its lead candidate Halneuron, positioning the company to address a $2 billion unmet market for non‑opioid neuropathic pain treatments. The partnership with Serpin Pharma, which holds the IND and provided the NCI grant, gives Dogwood a royalty‑free global license for SP16.
“FDA acceptance of our SP16 IND filing represents an important step in expanding our pipeline as we advance a second development candidate into the clinic to treat chemotherapy‑induced neuropathy and pain.” – Greg Duncan, Chairman and Chief Executive Officer of Dogwood Therapeutics.
“SP16 compliments our lead candidate, Halneuron®, by not only targeting neuropathic pain but also addressing additional debilitating symptoms of neurotoxic chemotherapy, including numbness, tingling and impaired motor function.” – Greg Duncan, Chairman and Chief Executive Officer of Dogwood Therapeutics.
The Phase 1b trial will provide early safety and pharmacodynamic data that will inform the design of subsequent studies and help Dogwood demonstrate the clinical value of SP16 in a patient population with limited treatment options.
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