Alkem Laboratories Ltd. (BSE: 539523, NSE: ALKEM) has announced a significant partnership with US-based Sonnet BioTherapeutics Holdings, Inc., marking a crucial step in the development of innovative treatments for diabetic peripheral neuropathy (DPN) in India. This collaboration centers around the drug candidate SON-080, which is Sonnet’s proprietary version of atexakin alfa. The development of this drug comes in response to the increasing burden of diabetes-related complications in India, where diabetic peripheral neuropathy affects approximately 62% of individuals with diabetes.

SON-080 has already shown encouraging results in a Phase 1b clinical trial, demonstrating its potential effectiveness in alleviating symptoms associated with diabetic peripheral neuropathy. The trial indicated that the drug was well-tolerated by patients, and the results from pain and quality of life surveys suggested that SON-080 may lead to rapid improvement in peripheral neuropathy symptoms, alongside post-dosing durability compared to placebo controls. Such promising outcomes highlight the necessity for continued development of effective therapies for a condition that significantly affects the quality of life for those living with diabetes.

Under the terms of the licensing agreement, Alkem Laboratories will take charge of the clinical development of SON-080 in India, with support from Sonnet. This partnership grants Alkem exclusive rights to develop, manufacture, and commercialize the drug candidate in the Indian market. The regulatory filings for both global and Indian markets will also be facilitated through this collaboration, ensuring a robust pathway for bringing this much-needed treatment to patients suffering from diabetic peripheral neuropathy.

The prevalence of diabetic peripheral neuropathy is a pressing public health concern in India, where it primarily affects the hands and lower limbs of individuals with diabetes. This condition can result in a loss of protective sensation, increasing the risk of unnoticed injuries, particularly to the feet. Over time, such injuries can lead to severe complications, including amputation. The partnership between Alkem and Sonnet is not just about drug development; it's a response to a critical healthcare need that has far-reaching implications for millions of people in India.

Dr. Akhilesh Sharma, President and Chief Medical Officer of Alkem, expressed enthusiasm about this partnership, stating, “We believe SON-080 is a unique asset that has demonstrated promising disease-modifying potential for diabetic peripheral neuropathy.” He emphasized the significant prevalence of the condition in India and how the drug development is vital in addressing this public health issue.

On the other hand, Pankaj Mohan, Founder and Chief Executive Officer of Sonnet, shared his excitement regarding the collaboration, highlighting Alkem's extensive experience and expertise in the pharmaceutical industry. He stated, “We believe that Alkem is the ideal partner with significant experience and expertise,” which sets a strong foundation for the advancement of SON-080 into Phase 2 clinical development.

The journey of SON-080 has been extensive, with many years of development and previous clinical trials generating safety data from over 200 patients. The drug candidate has not only shown promise for diabetic peripheral neuropathy but has also demonstrated preclinical efficacy data in treating chemotherapy-induced neuropathy. This includes the ability to prevent the onset of neuropathy and even reverse established neuropathy, as assessed through various measurements including nerve conduction, histological integrity, and sensorimotor function.

As the Indian healthcare sector continues to evolve, partnerships like that of Alkem and Sonnet pave the way for innovative solutions to longstanding health challenges. The collaboration not only reflects a commitment to addressing urgent medical needs but also emphasizes the role of pharmaceutical companies in developing effective treatments that can potentially change the lives of many.

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