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January 6, 2022

Regulatory roundup: Albireo ASBT inhibitor shot at further study rises in liver diseases

Roche in ulcerative colitis and Alzamend Neuro in dementia associated with Alzheimer’s disease are also reviewed by GlobalData’s Investigative News team.

By William Newton

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 regulatory support; 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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Albireo unveils liver disease data

Albireo Pharma’s A3907 for liver diseases saw its PTSR climb after positive topline results from a Phase I trial were revealed. The PTSR rose 11 points in primary sclerosing cholangitis (PSC) and in primary biliary cholangitis (PBC), bringing their respective rates to 72% and 71%.

The Phase I study met its primary endpoints of no reported serious adverse events (AEs) or discontinuations due to treatment emergent AEs. The most common treatment emergent AEs, all of which were mild, were abdominal symptoms like loose stools. A3907 also did not have any clinically significant effects on hematology, clinical chemistry, physical examinations, or in electrocardiogram analyses.

Albireo announced topline results on 16 December, and the PTSR changes took effect 20 December. The positive Phase I did not affect the drug’s LoA, which held steady at 0% and 3% for PSC and PBC.

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A3907 is an apical sodium-dependent bile acid transporter (ASBT) inhibitor that could inhibit ASBT expressed by cholangiocytes. PSC and PBC are chronic cholestatic liver diseases that can progress to end-stage liver disease over 10–20 years.

Roche makes progress in ulcerative colitis

Roche’s efmarodocokin alfa for moderate-to-severe ulcerative colitis saw its PTSR jump nine points to 35% after its Phase II trial completed. Efmarodocokin alfa targets the interleukin-22 receptor, generating potential anti-inflammatory effects.

ClinicalTrials.gov updated the Phase II trial (NCT03558152) from “active, not recruiting” to “completed” on 20 December, and the PTSR change occurred 21 December. The 195-patient Phase II was designed to compare efmarodocokin, also known as UTTR1147A, against Takeda Pharmaceutical’s Entyvio (vedolizumab) and placebo.

The first part of the study focused on induction of clinical remission of ulcerative colitis, while the second part tested the durability of remission. The Phase II has a primary endpoint of percentage of patients with clinical remission after eight weeks.

The completed Phase II also bumped the drug’s LoA up three points to 11%. Efmarodocokin alfa is under investigation by Roche’s subsidiary Genentech.

Alzamend Neuro shares positive Phase I topline data

Alzamend Neuro’s AL-001 for dementia associated with Alzheimer’s disease saw its PTSR leap 15 points to 73%. This is on the heels of the company announcing positive topline results on 17 December from a Phase I trial.

The Phase I is designed to find an appropriate Phase II dose. Study data shows AL-001, which has an oral lithium delivery system, is bioequivalent to lithium carbonate. Lithium carbonate is approved for bipolar disorder.

The Phase I also shows both AL-001 and lithium carbonate had similar time curves on their respective lithium plasma concentration levels. AL-001 is a lithium-salcylate-L-proline engineered ionic cocrystal. The positive Phase I also slightly upped the drug’s LoA by two points to 9%. Both the PTSR and LoA were updated on 21 December.

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