Trials start for Equillium drug for autoimmune disease after India approval

US pharma company Equillium has expanded the clinical trials for itolizumab to patients of autoimmune disease Lupus Nephritis after getting approval from the India’s drugs regulator.

Biocon developed itolizumab and received approval for the treatment of plaque psoriasis in India in 2013. Equillium secured exclusive rights to develop and commercialise itolizumab for the US and Canada markets, in May 2017. The license agreement for itolizumab was expanded in December 2019 to include Australia and New Zealand.

“We are happy to announce the commencement of our partner Equillium’s Phase 1b clinical study in India to evaluate the safety and early efficacy of Biocon Biologics’ novel antibody, Itolizumab, in treating Lupus Nephritis,” said Sandeep Athalye, Chief Medical Officer, Biocon Biologics.

Systemic Lupus Erythematosus (SLE), or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the US has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000.

“In India, approximately 45,000 patients are diagnosed with Systemic Lupus Erythematosus (SLE), of which over 20,000 patients have kidney involvement (nephritis), many of which do not respond to standard available therapy with steroids and immunosuppressive drugs,” said Athalye.