Aurobindo Pharma’s subsidiary, CuraTeQ Biologics, has introduced profitable trial outcomes for its new bone remedy drugs. The drug, known as BP16, is a duplicate of an present drugs known as denosumab.
The corporate examined the drug on 204 wholesome volunteers, evaluating it with Prolia — the unique model offered in Europe and the USA.
The drug works by blocking a protein known as RANKL, which is answerable for breaking down bone tissue.
This makes it helpful for treating:
- Bone thinning (osteoporosis) in ladies after menopause
- Bone issues brought on by most cancers spreading
- Bone weak spot from most cancers remedies
The profitable trial is a key step in the direction of bringing this doubtlessly extra reasonably priced model of the drugs to sufferers.
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Arpitkumar Prajapati, Head of Scientific Sciences at CuraTeQ Biologics, mentioned, “The outcomes from our study confirmed that BP16 displays a PK profile almost similar to the reference merchandise, reaching key bioequivalence parameters — most serum focus and space beneath the curve — inside the established bioequivalence vary of 80-125%.”
“Moreover, BP16 demonstrated comparable pharmacodynamics, security, and immunogenicity profiles to each EU and US variations of the reference product. The study, which included 204 topics from Australia and New Zealand, efficiently met all of the predefined endpoints.”
Dr Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics, mentioned, “With the constructive Phase 1 study outcomes, we’re optimistic about our ongoing Phase 3 study. This study is progressing throughout a number of websites within the EU, specializing in ladies with postmenopausal osteoporosis, and we anticipate its completion by Might/June 2025.”
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Shares of Aurobindo Pharma Ltd ended at ₹1,057.95, down by ₹38.85, or 3.54%, on the BSE.
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