Sonnet BioTherapeutics Moves Toward Phase 2 in Clinical Trial for Neuropathy Treatment

Sonnet BioTherapeutics, Inc. has announced the successful completion of the Phase 1b part of its Phase 1b/2a study, enabling progression to Phase 2 for its SON-080 candidate in the treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN). The study's Data Safety Monitoring Board (DSMB) reviewed the safety and tolerability of SON-080, finding it consistent with data from previous studies on IL-6 candidates. The Phase 1b objective for safety was thus met.

The trial, conducted in Australia, tests a new version of recombinant human Interleukin-6 (rhIL-6) for its safety before advancing its development. Positive outcomes in this phase signal potential for treating peripheral neuropathies, a condition with significant unmet needs. Initial reactions to SON-080 were manageable, and all adverse events were found to be transient and reversible. Based on these observations, plans are now in preparation to initiate a Phase 2 trial in Diabetic Peripheral Neuropathy (DPN) following potential partnership agreements.

Dr. Pankaj Mohan, Founder and CEO of Sonnet, emphasized the trial's significance in exploring SON-080's neuroprotective and neuro-regenerative effects. The larger market opportunity of DPN has generated substantial interest, prompting the company to prioritize it for Phase 2 development. The successful navigation through Phase 1b paves the way for further investigation into SON-080’s therapeutic efficacy in a broader neuropathy context.