Hansa Medical announces receipt of orphan drug designation from US FDA for IdeS to treat Guillain-BarrA(c) syndrome.
M2 EQUITYBITES-February 19, 2018-Hansa Medical announces receipt of orphan drug designation from US FDA for IdeS to treat Guillain-BarrA(c) syndrome
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Biopharmaceutical company Hansa Medical AB (STO:HMED) announced on Friday the grant by the US Food and Drug Administration (FDA) of orphan drug designation (ODD) to IdeS for the treatment of Guillain-Barre syndrome (GBS).
According to the company, it is now planning a phase II study in GBS with IdeS, an IgG-degrading enzyme of Streptococcus pyogenes that depletes IgG antibodies fast and effectively.
Guillain Barre syndrome (GBS) is an acute autoimmune disease in which the peripheral nervous system is attacked by the immune system and IgG-antibodies.
Hansa Medical is developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases. The lead product, IdeS, is a proprietary antibody-degrading enzyme currently in late-stage clinical development for kidney transplant patients, with significant potential for further development in other solid organ transplants and in acute autoimmune indications.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Feb 19, 2018|
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