Sonnet BioTherapeutics and Alkem Laboratories Partner to Develop and Market SON-080 for DPN in India

Sonnet BioTherapeutics Holdings, Inc., a clinical-stage company specializing in targeted immunotherapeutic drugs, has announced a new licensing agreement with Alkem Laboratories Limited. This agreement focuses on the research, development, production, marketing, and sale of SON-080, a drug targeting diabetic peripheral neuropathy (DPN) in India. Alkem will also be responsible for the development and commercialization of SON-080 for chemotherapy-induced neuropathy (CIPN) and autonomic neuropathy within the Indian market. SON-080, Sonnet's proprietary recombinant human Interleukin-6 (rhIL-6), shares a mechanism of action across these neuropathies.

Under the terms of the agreement, Sonnet will receive an upfront payment of $1.0 million and may earn up to an additional $1.0 million through milestone payments. The company is also entitled to a royalty in the low double digits on net sales in the Indian market, minus specific expenses. Alkem is tasked with conducting the necessary clinical trials to secure regulatory approval in India. Additionally, data generated from these trials can be accessed by Sonnet for a fee, aiding in their efforts to form partnerships in markets outside India.

The market for diabetic neuropathy in India was valued at $120.3 million in 2023 and is expected to grow to $246.7 million by 2030. Sonnet has recently shared data from the completed Phase 1b segment of their ongoing Phase 1b/2a clinical trial for SON-080 targeting CIPN. Results indicated that the drug was well-tolerated with no evidence of a pro-inflammatory cytokine response and suggested potential rapid improvement in peripheral neuropathy symptoms.

Pankaj Mohan, the CEO of Sonnet, expressed enthusiasm about the collaboration with Alkem, emphasizing their extensive experience and expertise. He highlighted that the data from Alkem's planned Phase 2 study could facilitate additional partnerships in other significant markets, thereby providing a much-needed therapeutic option for patients with DPN.

Dr. Akhilesh Sharma, Alkem’s President and Chief Medical Officer, echoed the sentiment, expressing confidence in SON-080's potential. He emphasized the significant prevalence of DPN in India and the necessity for its development.

DPN, a painful and disabling condition, affects about 50% of diabetic patients. Current treatments mainly address pain symptoms and fail to manage the underlying nerve degeneration. Preclinical models have shown that low-dose IL-6 can stimulate peripheral nerve growth, improving motor and sensory functions and normalizing pain or sensation disturbances associated with neuropathy.

SON-080 has undergone extensive development, with prior clinical trials involving over 200 patients demonstrating safety. The drug has shown promising preclinical efficacy in both DPN and CIPN, displaying the ability to prevent and reverse neuropathy as measured by nerve conduction, histological integrity, and sensorimotor function.

Sonnet's lead program, SON-1010, is in development for treating solid tumors and ovarian cancer. It is currently being evaluated in a Phase 1/2a study in collaboration with Roche. Additionally, Sonnet is exploring its second program, SON-1210, targeting solid tumors through a Phase 1/2a study for pancreatic cancer.

Alkem Laboratories Limited, a prominent Indian pharmaceutical company, boasts a 50-year legacy of providing high-quality medicines. It ranks as the fifth-largest pharmaceutical company in India and has a strong presence in various therapeutic areas. The company operates 19 state-of-the-art manufacturing facilities and advanced research and development centers across India and the US. Besides its significant presence in India, Alkem has a meaningful footprint in markets including the US, Latin America, Australia, and several Asian countries.