Sonnet BioTherapeutics' SON-080 Phase 1b/2a CIPN Trial Meets Initial Safety Objectives

The Data Safety Monitoring Board (DSMB) has reviewed the safety of SON-080 in the Phase 1b part of Sonnet's clinical trial. The adverse events and tolerability of SON-080 were in line with previous candidates, fulfilling the Phase 1b safety goals. This safety data will support the initiation of a Phase 2 trial aiming at Diabetic Peripheral Neuropathy (DPN), after securing a partnership.

Sonnet BioTherapeutics Holdings, a clinical-stage company developing immunotherapeutic drugs, announced that the Phase 1b trial of SON-080 has been cleared to proceed to Phase 2. The study, conducted in Australia, used a new version of recombinant human Interleukin-6 (rhIL-6) in patients with persistent CIPN. CIPN causes nerve damage and pain that can affect chemotherapy treatments.

The trial used low doses of rhIL-6 with an amino acid sequence identical to the native molecule, aiming to mimic natural healing levels seen in moderate exercise. This cytokine participates in tissue repair, glucose homeostasis, and immune responses but can cause inflammation at higher levels. Preclinical models showed low doses of rhIL-6 could stimulate nerve regrowth, reducing pain and normalizing physiological conditions.

Earlier versions of rhIL-6 like Serono's atexakin alfa were tested and showed a maximum tolerated dose with some side effects at higher doses. The Phase 1b trial aimed to establish safety with lower doses of Sonnet’s IL-6 (SON-080) in patients with CIPN. DSMB reviewed the unblinded safety data for the first nine patients, noting prominent but tolerable symptoms like injection site reactions and mild to moderate system-wide symptoms.

One patient experienced severe fatigue and withdrew from the trial. DSMB deemed symptoms tolerable, allowing the trial to proceed to Phase 2. Unblinded safety data comparisons are expected in the latter half of 2024.

The completion of Phase 1b is a significant milestone for Sonnet in developing treatments for peripheral neuropathies. The trial aimed to build on historical safety data and study neuroprotective effects in Phase 2 for neurotherapy. The larger market opportunity for DPN has attracted interest in potential partnerships.

Sonnet plans to utilize the safety and tolerability data from CIPN to launch a Phase 2 study for DPN. Preliminary efficacy is being evaluated using pain questionnaires, and the trial is conducted in a blinded fashion comparing SON-080 to placebo.

Sonnet BioTherapeutics specializes in oncology with a platform for biologic drugs using the FHAB (Fully Human Albumin Binding) technology, designed to target tumor and lymphatic tissue.

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