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Abetimus (La Jolla pharmaceuticals).

Hanns-Martin Lorenz1

  • 1University of Erlangen-Nuremberg, Department of Medicine III, Institute of Clnical Immunol/Rheumatology, Germany. Hannes.Lorenz@med3.imed.uni-erlangen.de

Current Opinion in Investigational Drugs (London, England : 2000)
|May 22, 2002
PubMed
Summary

Abetimus (LJP-394), a novel oligonucleotide conjugate, is being developed for lupus and lupus kidney disease. Phase III trials were initiated in 2000 to evaluate its efficacy, with Orphan Drug status granted in the US and EU.

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Area of Science:

  • Immunology
  • Nephrology
  • Pharmacology

Background:

  • Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with significant morbidity, particularly lupus kidney disease (LKD).
  • Current treatments for LKD have limitations, necessitating the development of novel therapeutic agents.
  • Abetimus (LJP-394) represents a new class of immunomodulatory drugs targeting B-cell epitopes.

Purpose of the Study:

  • To evaluate the efficacy and safety of abetimus (LJP-394) in patients with lupus, specifically focusing on lupus kidney disease.
  • To support regulatory filings for abetimus by completing pivotal Phase III clinical trials.

Main Methods:

  • Initiation of Phase III clinical trials for abetimus in September 2000, enrolling approximately 300 patients.
  • Multi-center trial design with sites across North America and Europe, aiming to replicate positive Phase II/III study results.
  • Utilizing abetimus, a tetrakis-oligonucleotide conjugate developed using Tolerance Technology.

Main Results:

  • Phase III trials were ongoing as of July 2001, with patient enrollment and dosing initiated.
  • The drug received Orphan Drug status in the US (September 2000) and EU (November 2001), facilitating development.
  • Patents covering abetimus and its underlying Tolerance Technology were secured, including composition of matter and method of use patents.

Conclusions:

  • Abetimus (LJP-394) is a promising therapeutic candidate for lupus and lupus kidney disease.
  • The ongoing Phase III trials are critical for demonstrating the drug's clinical benefit and paving the way for potential market approval.
  • The intellectual property landscape supports the commercialization of abetimus and related technologies.

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