Sage Therapeutics Alzheimer's drug likely to progress: regulatory roundup
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Regulatory roundup: Sage Alzheimer’s asset likely to progress after Phase IIa completion

By Reynald Castaneda 16 Nov 2021 (Last Updated November 16th, 2021 10:45)

Eli Lilly’s solid tumour asset and AriBio in mild-to-moderate AD are also reviewed by GlobalData’s Investigative News team.

Regulatory roundup: Sage Alzheimer’s asset likely to progress after Phase IIa completion
Sage has said it anticipates topline results from the LUMINARY trial in mild dementia or cognitive impairment associated with AD later this year. Credit: Shutterstock

Need to know:

GlobalData’s Investigative News team reviews data generated by an in-house model that combines machine learning and its proprietary algorithm. Likelihood of Approval (LoA) provides the probability of a drug in securing market authorization; Phase Transition Success Rate (PTSR) indicates the probability of a drug advancing to the next stage of development. The model uses data points from individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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Sage completes Alzheimer’s disease Phase II test

Sage Therapeutics’ SAGE-718 for dementia associated with Alzheimer’s disease (AD) saw its PTSR leap 10 points to 55% after a Phase II trial was completed. The study completed on 21 September, according to an update to ClinicalTrials.gov on 4 November. The PTSR change took effect on 5 November.

The open-label Phase IIa LUMINARY trial (NCT04602624) enrolled 26 patients with mild dementia or cognitive impairment associated with AD. Incidence of treatment-emergent adverse events was the primary endpoint, and the study focused on overall safety and tolerability.

SAGE-718 is a positive allosteric modulator of N-methyl-D-aspartate (NMDA) receptors and is also under development for Parkinson’s disease and Huntington’s disease. Sage has said it anticipates topline results from the LUMINARY trial later this year. The completed trial also led to a four-point jump in the drug’s LoA, which rose to 19%.

Lilly asset unlikely to progress in solid tumours

Eli Lilly’s cancer asset LY3405105 saw its PTSR across five different indications plunge after the termination of its Phase I study. The PTSR fell by 39 points to 72% in synovial sarcoma and to 71% in rhabdomyosarcoma. It also dropped by 37 points to 30% in soft tissue sarcoma and by 34 points to 28% in ovarian cancer, while also dipping by 26 points to 16% in solid tumors. The trial’s ClinicalTrials.gov page was updated on 8 November. GlobalData appraised the asset on 9 November.

The 54-subject study (NCT03770494) was terminated on grounds of insufficient efficacy. The trial mainly investigated dose-limiting toxicities but had a bevy of secondary efficacy endpoints from pharmacokinetics to overall survival. LY3405105 is an oral cyclin dependent kinase inhibitor, targeting cyclin dependent kinase 7 (CDK-7).

The study termination also saw a fall in the asset’s LoA. The LoA dropped by three points to 2% in soft tissue sarcoma and by 1 point to 0% in synovial sarcoma and solid tumours. The LoA also declined by one point to 2% in ovarian cancer, while stagnating at 0% in rhabdomyosarcoma.

AriBio releases Alzheimer’s disease data

AriBio’s AR1001 saw its PTSR in mild-to-moderate AD jump 12 points to 47% on the heels of Phase II results. The Seongnam, South Korea-based company released topline results in a 4 November press release, and the PTSR change took effect on 8 November.

The 210-patient Phase II trial (NCT03625622) evaluated AR1001 with the coprimary endpoints of ADAS-Cog 13, an Alzheimer’s Disease Assessment Scale-Cognitive Subscale and ADCS-CGIC, the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change scale. There was a 1.17-point and 0.76-point decline in ADAS-Cog 13 for the high and low-dose treatment groups, respectively, compared to an estimated 5.5-point average decline with placebo. There was no statistically significant effect on ADCS-CGIC compared to placebo for either treatment dose.

AR1001 can inhibit neuron apoptosis and restore synaptic plasticity, potentially providing neuroprotective effects. The completed trial also led to a modest one-point rise in the drug’s LoA, which sits at 3%.