(Sodium phenylbutyrate + taurursodiol) is under clinical development by Amylyx Pharmaceuticals and currently in Phase II for Alzheimer’s Disease. According to GlobalData, Phase II drugs for Alzheimer’s Disease have a 36% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how (Sodium phenylbutyrate + taurursodiol)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
(Sodium phenylbutyrate + taurursodiol) overview
Sodium phenylbutyrate and Taurursodiol (Albrioza, Relyvrio) is a fixed dose combination product. It is formulated as powder for suspension for oral route of administration. Albrioza is indicated in the treatment of adult patients with amyotrophic lateral sclerosis (ALS). Relyvrio is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
AMX-0035 is under development for the treatment of Alzheimer's disease, amyotrophic lateral sclerosis, multiple sclerosis and wolfram syndrome (genetic disorder). It is a combination of sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA). The drug candidate is administered as powder for oral suspension. It acts by targeting the translocation of the Bcl-2 associated X-protein(Bax). It was also under development for the treatment of Friedreich's ataxia.
.
Amylyx Pharmaceuticals overview
Amylyx Pharmaceuticals (Amylyx) discovers and develops pharmaceutical products for the treatment of neurodegenerative diseases. The company is investigating AMX0035, an oral coformulation of sodium phenylbutyrate and taurursodiol compounds to treat amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Wolfram syndrome. Its product candidate focuses on reducing neuronal death by mitigating endoplasmic reticulum stress and mitochondrial dysfunction. Amylyx seeks to work in collaboration with researchers and biotechnology companies to develop its products. The company has operational presence in Calgary, Canada and Amsterdam, the Netherlands. Amylyx is headquartered in Cambridge, Massachusetts, the US.
For a complete picture of (Sodium phenylbutyrate + taurursodiol)’s drug-specific PTSR and LoA scores, buy the report here.
Premium Insights
From
The gold standard of business intelligence.
Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.
GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
Smarter leaders trust GlobalData
Premium Insights Likelihood of Approval and Phase Transition Success Rate Model - (Sodium Phenylbutyrate + Taurursodiol) in Alzheimer's Disease
Premium Insights
The gold standard of business intelligence.
