Sonnet BioTherapeutics Reports Encouraging Data from Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) That Support Advancement into Phase 2 Study

Core Insights - The Phase 1b study of SON-080 demonstrated its potential as a treatment for chemotherapy-induced peripheral neuropathy (CIPN), showing promising safety and tolerability profiles [12][8][5] - SON-080, a low dose recombinant human Interleukin-6 (rhIL-6), is being developed to address the significant unmet medical need for effective treatments for CIPN and diabetic peripheral neuropathy (DPN) [11][8] Group 1: Study Design and Results - The SB211 study was a double-blind, randomized, controlled trial conducted in Australia, evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and initial efficacy of SON-080 in patients with persistent CIPN [5][12] - A total of 9 patients were randomized into two SON-080 dose groups and a placebo group, with a treatment period of 12 weeks followed by an additional 12 weeks of follow-up [13] - Preliminary results indicated a trend toward improved quality of life and pain scores in patients receiving SON-080 compared to placebo, with benefits persisting after treatment cessation [3][12] Group 2: Safety and Tolerability - SON-080 was well-tolerated at both 20 µg and 60 µg doses, significantly lower than the maximum tolerated dose established in previous studies [2][12] - The most common treatment-related adverse event was mild injection site erythema, with fatigue reported more frequently at the higher dose [2][12] - No significant pro-inflammatory cytokine response was observed, and any increases in serum amyloid alpha were deemed benign [10][12] Group 3: Future Development and Market Potential - The company plans to advance SON-080 into a Phase 2 study focusing on its neuroprotective and neuro-regenerative effects in DPN, a condition with high prevalence and unmet medical need [8][12] - The management expressed intentions to seek partnerships to facilitate the commercialization of SON-080, highlighting the potential market opportunity in treating neuropathies associated with cancer and diabetes [8][9]