Mumbai-based Alkem Laboratories has entered into a licensing agreement with US-based Sonnet BioTherapeutics Holdings, Inc to develop, manufacture and commercialise the drug candidate SON-080 for the treatment of diabetic peripheral neuropathy in India.

SON-080 is Sonnet’s proprietary version of atexakin alfa. It has shown encouraging data in phase 1b clinical trial. The drug candidate was demonstrated to be well-tolerated and the pain and quality of life survey results suggested a potential for rapid improvement of peripheral neuropathy symptoms and post-dosing durability, compared to placebo controls.

Under the licensing agreement, Alkem will carry out the clinical development of SON-080 in India with support from Sonnet and enable global and India regulatory filings. Alkem has exclusive rights to develop, manufacture and commercialise the drug in India.

India is grappling with a substantial burden of diabetes-related complications with diabetic peripheral neuropathy being a major one. Diabetic peripheral neuropathy is notably widespread, affecting up to 62% of people with diabetes mellitus in India. Diabetic peripheral neuropathy primarily affects the hands and lower limbs. It can result in a loss of protective sensation, making individuals more prone to unnoticed injuries, particularly to the feet. Over time, this can lead to the development of serious complications, including amputation. 

SON-080 has undergone many years of development and the previous clinical trials have generated safety data from over 200 patients. SON-080 has demonstrated compelling preclinical efficacy data in both diabetic peripheral neuropathy and chemotherapy induced neuropathy, including the ability to prevent the development of neuropathy and reverse established neuropathy when assessed by nerve conduction, histological integrity and sensorimotor function measurements.