Italfarmaco To Seek Givinostat Approvals After Phase III Success In DMD
Capricor Reported Long-Term Data For Its Cell Therapy
Italfarmaco’s HDAC inhibitor helped ambulatory Duchenne muscular dystrophy patients climb stairs faster than non-treated boys while Capricor’s cell therapy improved upper limb function in non-ambulatory patients.
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Santhera is bouncing back after a Duchenne drug failure two years ago with idebenone, and is looking to gain approval of vamorolone in this indication as well as the much rarer Becker muscular dystrophy.
Capricor will start a Phase II trial in the first quarter of 2018 for its regenerative cell therapy CAP-1002 in Duchenne muscular dystrophy following positive results in an early-stage trial – the stem cell product was dropped by Capricor's big pharma partner Johnson & Johnson earlier this year.
The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab.