PRINCETON, NJ - Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage biotech company, announced today that its Phase 1b/2a clinical trial of SON-080 has been cleared to progress to Phase 2. This decision comes after a favorable review from the independent Data Safety Monitoring Board (DSMB) regarding the safety of the drug in treating chemotherapy-induced peripheral neuropathy (CIPN).
The trial, conducted in Australia, is evaluating a low dose of recombinant human Interleukin-6 (rhIL-6) in patients with persistent CIPN. SON-080 aims to replicate the healing effects of moderate exercise on nerve tissue, potentially stimulating nerve regrowth and reducing pain. The safety profile observed in the study aligns with previous data on IL-6 candidates, with reported adverse events being transient and reversible.
The DSMB's review included the first nine patients and found the treatment tolerable, allowing the study to move forward. The symptoms experienced by participants, such as injection site reactions and fatigue, were mostly mild, with one case of severe fatigue leading to withdrawal from the study.
With the completion of the Phase 1b portion, Sonnet plans to leverage this data to support a Phase 2 trial in Diabetic Peripheral Neuropathy (DPN), a condition with a larger market potential. The company is pursuing partnerships to further the development and potential commercialization of SON-080.
Sonnet's Chief Executive Officer, Pankaj Mohan, Ph.D., emphasized the unmet need for effective treatments for peripheral neuropathies and the company's commitment to addressing this challenge. The company's Chief Medical Officer, Richard Kenney, M.D., highlighted the potential of SON-080 to treat the underlying causes of peripheral neuropathy rather than just masking symptoms.
The SB211 study primarily focuses on the safety, pharmacokinetics (PK), pharmacodynamics (PD), and initial efficacy of SON-080 compared to a placebo. The primary endpoint is safety and tolerability, with secondary endpoints assessing PK, PD, and immunogenicity. Initial efficacy is being explored through standardized pain questionnaires.
Sonnet BioTherapeutics specializes in developing targeted immunotherapeutic drugs and utilizes its proprietary FHAB (Fully Human Albumin Binding) technology for better targeting and efficacy in immune-modulating biologic drugs.
The company's forward-looking statements indicate its plans and potential but also acknowledge the risks and uncertainties inherent in drug development. The unblinded safety data from the trial is expected in the second half of 2024, and the information provided is based on a press release statement.
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