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November 23, 2021updated 14 Mar 2022 11:30am

Regulatory roundup: AbbVie’s Phase II fail plunges Alzheimer’s contender’s shot at further study

Avalo in Crohn’s disease and RemeGen in Berger’s disease are also reviewed by GlobalData’s Investigative News team.

By Reynald Castañeda

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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AbbVie collapses in Alzheimer’s disease

AbbVie ’s tilavonemab for early Alzheimer’s disease (AD) took a 26-point tumble in its PTSR after a failed Phase II trial. The results were published in a Clinical Trials on Alzheimer’s Disease (CTAD) conference abstract on 13 November, and the PTSR change occurred on 17 November.

In the 453-patient Phase II trial (NCT02880956), tilavonemab was not effective in treating patients with early AD (CTAD abstract ROC19). The co-primary endpoints were Clinical Dementia Rating-Sum of Boxes (CDR-SB) and incidence of adverse events. Mean CDR-SB worsened for all treatment groups through week 96, and there were no significant improvements in cognition in any secondary endpoints.

The trial result also dropped the drug’s LoA from 3% to 1%. Tilavonemab is an immunoglobulin G4 monoclonal antibody that targets the soluble extracellular protein tau in the brain, which has been implicated in the AD pathway.

Avalo announces Crohn’s disease updates

Avalo Therapeutics’ Crohn’s disease candidate AVTX-002 saw its PTSR skyrocket 44 points after recent drug-related updates. The updates also led to a hefty 18-point boost in the drug’s LoA, which sits at 27%.

According to the 3Q results released on 9 November, the company completed enrollment in the second cohort of an ongoing Phase Ib trial (NCT03169894) with AVTX-002 and expects topline data 4Q. AVTX-002 also received FDA Orphan Drug Designation on 26 October, according to FDA documents.

The 8-patient Phase Ib trial has four safety and tolerability-related primary endpoints: incidence of treatment-emergent adverse events, vital signs findings, and electrocardiogram (ECG) and clinical laboratory findings. The trial enrolled adults with moderate-to-severe active Crohn’s disease who had previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatments.

AVTX-002, also known as MDGN-002, is a monoclonal antibody specific to human LIGHT or TNF superfamily member 14 (TNFSF14).

RemeGen reports Berger’s disease data

RemeGen ’s telitacicept saw its PTSR in Berger’s disease jump after the announcement of positive Phase II study results. The PTSR grew by 11 points to 63%.

The 44-subject Phase II study (NCT04291781) had its results unveiled during a 4 November session at the American Society of Nephrology Kidney Week. GlobalData updated the PTSR on 10 November.

The trial had a primary endpoint of 24-hour urine protein excretion level change from baseline. Telitacicept delivered a 49% reduction in the 240mg dose, and a 25% drop in the 160mg arm. In Berger’s disease, telitacicept is designed to ease urinary protein levels, which are at higher rates in this indication.

Telitacicept’s LoA remained stagnant at 3% despite the positive Phase II data. In China, telitacicept was approved in March 2021 for the treatment of systemic lupus erythematosus (SLE) and goes by the brand name Tai Ai.

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