Comments
Biotechnology major, Biocon, on Wednesday, said it has initiated a clinical study in collaboration with Equillium Inc to evaluate efficacy of Itolizumab in patients with Ulcerative Colitis.
This is a phase two randomised, double-blind, parallel-group, placebo and active-controlled (adalimumab), two-treatment period study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naive patients with moderate to severely active Ulcerative Colitis (UC), Biocon said in a statement.
Having obtained approval from the Drugs Controller General of India (DCGI), the study will cover several tertiary hospitals specialised in handling UC cases, it added.
Related Stories
Drug trials may soon be done on human tissues, cells developed in labs; change in rules in offing
Once the amendments to the New Drugs and Clinical Trials Rules, 2019, are approved and notified by the Health Ministry, India will become the second country in the world to adopt such innovative and cutting-edge technologiesThe first patient who intended to participate in the study was screened on December 1, 2022, the company said.
"The commencement of Phase two clinical study, which will determine its efficacy for the treatment of Ulcerative Colitis, is an important step forward in our efforts to bring its benefit to patients in India suffering from this disease," Biocon Managing Director and CEO Siddharth Mittal said.
The development also underpins the company's commitment to bring innovative, affordable medicines, which address unmet patient needs, to market expeditiously, he added.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.