CuraTeQ Biologics, (a wholly owned subsidiary of Aurobindo Pharma) has announced successful Phase I study results for its new bone treatment medicine. The drug, BP16, is a biosimilar referencing Denosumab (Prolia).

The company tested the drug on 204 healthy volunteers, comparing it with Prolia — the original version sold in Europe and the United States.

The drug works by blocking a protein called RANKL, which is responsible for breaking down bone tissue. This makes it useful for treating:

  • Bone thinning (osteoporosis) in women after menopause
  • Bone problems caused by cancer metastasis
  • Bone weakness from cancer treatments

The successful trial is a key step towards bringing this potentially more affordable version of the medicine to patients.

Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, said, “The results from our study confirmed that BP16 exhibits a PK profile nearly identical to the reference products, achieving key bioequivalence parameters — maximum serum concentration and area under the curve — within the established bioequivalence range of 80-125%.”

“Additionally, BP16 demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product. The study, which included 204 subjects from Australia and New Zealand, successfully met all the predefined endpoints.”

Dr Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics, said, “With the positive Phase 1 study results, we are optimistic about our ongoing Phase 3 study. This study is progressing across multiple sites in the EU, focusing on women with postmenopausal osteoporosis, and we anticipate its completion by May/June 2025.”

About CuraTeQ: CuraTeQ Biologics Private Limited (CuraTeQ), a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. CuraTeQ’s vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them access to high quality and cost-effective biosimilars. It is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: CNBC TV 18