Polpharma Biologics Partners with PSI CRO to Conduct a P-I Clinical Trial Evaluating PB018 (Biosimilar, Ocrevus)
Shots:
- Polpharma Biologics has partnered with PSI CRO to advance a P-I clinical trial evaluating PB018, its proposed biosimilar to Ocrevus (ocrelizumab), in multiple sclerosis pts, with the study expected to begin in October 2026
- The randomized P-I study will enroll approximately 222 participants to compare the PK, PD, safety, and immunogenicity of PB018 with Ocrevus, with PK similarity as the primary endpoint and secondary assessments including B-cell depletion, MRI lesion activity, immunogenicity, and safety over 24 wks.
- PB018 is an anti-CD20 mAb being developed for the treatment of relapsing and primary progressive multiple sclerosis
Ref: Polpharma | Image: Polpharma & PSI CRO | Press Release
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