ABBISKO-B (02256.HK): Lavengratinib shows positive interim Phase II results in achondroplasia
- In the initial and lowest dose cohort (0.064mg/kg once daily), seven participants aged 6 to 12 showed a mean AHV increase of +2.4 cm/year from baseline after 27 weeks of treatment, with a response rate of 100%, where responders are defined as participants with an AHV increase of at least 25% from baseline.
- ABSK061-202 is a Phase II, multicentre, open-label dose-escalation study evaluating lavengratinib in children with ACH aged 3 to 12, with all participants planned to receive 78 weeks of treatment; preliminary safety assessment of the first three dose cohorts has been completed, with six-month efficacy and safety results expected by the end of 2026.
- No serious adverse events or discontinuations due to adverse events have been reported to date, and no specific safety risks associated with FGFR pathway inhibition have been observed; lavengratinib uses a unique oral mini-tablet formulation with each tablet under 3 mm in diameter, and has been granted Rare Pediatric Disease Designation and Orphan Drug Designation by the US FDA.
NewTimeSpace News: On 21 September 2026, Abbisko Cayman Limited (stock code: 2256) published a voluntary announcement that its subsidiary Shanghai Abbisko Biotechnology Co., Ltd. announced positive interim efficacy results from a Phase II clinical study of its selective oral small molecule FGFR2/3 inhibitor lavengratinib (ABSK061) in children with achondroplasia (ACH).
The announcement stated that in the initial and lowest dose cohort (0.064mg/kg once daily), children with ACH aged six years and above showed a mean increase in annualized height velocity (AHV) of +2.4 cm/year from baseline after 27 weeks of lavengratinib treatment, with a response rate of 100%. Lavengratinib was generally well tolerated, with no adverse events associated with FGFR1 or FGFR2 observed. ABSK061-202 is a Phase II, multicentre, open-label dose-escalation study designed to evaluate the safety and efficacy of lavengratinib (once daily, oral) in children with ACH aged 3 to 12, with all participants planned to receive 78 weeks of treatment.
To date, seven participants aged 6 to 12 in the initial and lowest dose cohort have completed six months of treatment, with no serious adverse events or discontinuations due to adverse events reported, and no specific safety risks associated with FGFR pathway inhibition observed. The study has completed preliminary safety assessment of the first three dose cohorts, with six-month efficacy and safety results expected by the end of 2026. The announcement noted that lavengratinib has been granted Rare Pediatric Disease Designation and Orphan Drug Designation by the US FDA for the treatment of achondroplasia.
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