Kashiv Biosciences Reports P-I Clinical Study Results of ADL018 (biosimilar, omalizumab)
Shots:
- The P-I study has been completed evaluating ADL018, a biosimilar candidate to Xolair, EU-approved omalizumab, or US-licensed omalizumab via SC inj. in healthy volunteers
- The primary objective of the study was to demonstrate PK similarity by evaluating the area under the concentration-time curve from time zero to infinity (AUCinf) and Cmax and compare the safety & tolerability while the secondary objectives were to determine the PD activity & immunogenicity b/w three treatment groups
- The company plans to initiate the patients dosing in the P-III study shortly for CSU. Omalizumab was approved to treat persistent asthma in patients aged ≥6yrs. and chronic rhinosinusitis with nasal polyps in patients aged ≥18yrs.
Ref: Businesswire | Image: Kashiv
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