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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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ABBV-916 shows promising results in reducing brain amyloid in early Alzheimer

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Clinical Trials

Background:

  • Alzheimer's disease (AD) is a leading cause of dementia, characterized by progressive neurodegeneration.
  • ABBV-916 is an investigational therapy targeting pyroglutamate Aβ species in amyloid plaques.

Purpose of the Study:

  • To evaluate the efficacy, pharmacokinetics (PK), and safety of ABBV-916 in early AD.
  • Assess the impact of ABBV-916 on brain amyloid levels.

Main Methods:

  • Phase 1b/2, randomized, placebo-controlled study of ABBV-916 in adults (50-90 years) with early AD.
  • Participants received intravenous ABBV-916 or placebo every 4 weeks for 24 weeks.
  • Safety, PK, and amyloid PET scans were monitored.

Main Results:

  • PK exposure was dose-proportional with low inter-subject variability.
  • Doses of 300 mg and 900 mg ABBV-916 demonstrated dose-dependent brain amyloid reduction.
  • 60.0% and 85.7% of participants achieved amyloid negativity at Week 24 with 300 mg and 900 mg, respectively.

Conclusions:

  • ABBV-916 exhibits a safety and PK profile comparable to existing anti-amyloid immunotherapies.
  • Significant brain amyloid reduction was observed at doses of 300 mg and higher.