MapLight精神分裂症二期数据虽有BID剂量阳性但QD方案未达主终点，股价盘前大跌

MapLight Therapeutics (MPLT) stock tumbled in Monday premarket trading despite reporting positive Phase 2 trial results for its schizophrenia drug candidate, after a once-daily dosing regimen failed to achieve statistical significance on the primary endpoint.
The trial met its primary endpoint, with the 210/3 mg twice-daily dose demonstrating a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5, the company said.
The 330/6 mg once-daily dose, which results in lower daily exposure than BID dosing, demonstrated numerical improvement over placebo, but did not achieve statistical significance on the primary endpoint, MapLight Therapeutics (MPLT) noted.
The company is conducting further analyses to inform the potential path forward for a once-daily regimen, it said.
Additionally, the company recently reported results for IRIS, a Phase 2 trial evaluating ML-004, an 5-HT1B/1D agonist in autism spectrum disorder, where a prespecified subgroup analysis in adolescents with significant baseline irritability demonstrated meaningful improvement over placebo on both caregiver- and clinician-rated scales alongside a favorable safety and tolerability profile.
Based on these results, the company intends to engage with the FDA in an EOP2 meeting to determine the next steps for development of ML-004 in irritability associated with ASD, according to the statement on Monday.