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Stamulumab (MYO-029Wyeth Product Pipeline
,
Wyeth Wyeth Pharmaceuticals Inc. was a pharmaceutical company until it was purchased by Pfizer in 2009. The company was founded in Philadelphia, Pennsylvania, in 1860 as John Wyeth and Brother. Its headquarters moved to Collegeville, Pennsylvania, a ...
, Website accessed April 22, 2007
) is an experimental myostatin inhibiting drug developed by Wyeth Pharmaceuticals for the treatment of
muscular dystrophy Muscular dystrophies (MD) are a genetically and clinically heterogeneous group of rare neuromuscular diseases that cause progressive weakness and breakdown of skeletal muscles over time. The disorders differ as to which muscles are primarily affe ...
(MD). Stamulumab was formulated and tested by Wyeth in
Collegeville, Pennsylvania Collegeville is a borough in Montgomery County, Pennsylvania, a suburb outside of Philadelphia on Perkiomen Creek. Collegeville was incorporated in 1896. It is the location of Ursinus College, which opened in 1869. The population was 5,089 ...
. Myostatin is a
protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residue (biochemistry), residues. Proteins perform a vast array of functions within organisms, including Enzyme catalysis, catalysing metab ...
that inhibits the growth of muscle tissue, stamulumab is a recombinant human
antibody An antibody (Ab) or immunoglobulin (Ig) is a large, Y-shaped protein belonging to the immunoglobulin superfamily which is used by the immune system to identify and neutralize antigens such as pathogenic bacteria, bacteria and viruses, includin ...
designed to bind to and inhibit the activity of myostatin. Stamulumab is a G1
immunoglobulin An antibody (Ab) or immunoglobulin (Ig) is a large, Y-shaped protein belonging to the immunoglobulin superfamily which is used by the immune system to identify and neutralize antigens such as pathogenic bacteria, bacteria and viruses, includin ...
antibody which binds to myostatin and prevents it from binding to its target site, thus inhibiting the growth-limiting action of myostatin on muscle tissue. Research completed in 2002 found that Stamulumab might one day prove to be an effective treatment for
Duchenne muscular dystrophy Duchenne muscular dystrophy (DMD) is a severe type of muscular dystrophy predominantly affecting boys. The onset of muscle weakness typically begins around age four, with rapid progression. Initially, muscle loss occurs in the thighs and pe ...
.


Phase 1 and 2 trials

Wyeth undertook a Phase 1 and 2
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
in 2005 and 2006 of stamulumab. The multiple ascending dose trial (36 patients per cohort) contained some measures of efficacy. The trial's participants included people afflicted with facioscapulohumeral muscular dystrophy, Becker's muscular dystrophy, and Limb-girdle muscular dystrophy. Through 2007 Wyeth had been analyzing the results but the hoped-for news and/or a publication in 2007 did not occur.Wyeth Analyzing MYO-029 Results
, Muscular Dystrophy Association announcement, December 4, 2006
FSH Watch Newsletter
, pg 11, FSH Society, Summer 2007
On January 24, 2008, Wyeth announced that the study had been accepted by a peer-reviewed journal and publication was expected "in the next few months". The publication appeared in '' Annals of Neurology'' in May 2008. On 11 March 2008, it was announced that Wyeth would not develop the drug further for MD, but would continue to explore myostatin inhibition along with other strategies.


See also

* ACVR2B represents an alternative approach to inhibiting myostatin. Not belonging to the antibody class of molecules, the ACVR2B protein drug is rather mimicking myostatin's endogenous binding partner, therefore competing for its binding affinity.


References

{{TGFβ receptor superfamily modulators Drugs developed by Wyeth Abandoned drugs Monoclonal antibodies Myostatin inhibitors