Mallinckrodt plc enrolls first RA patient under Phase 4 clinical study of H.P. Acthar Gel.
M2 PHARMA-November 15, 2016-Mallinckrodt plc enrolls first RA patient under Phase 4 clinical study of H.P. Acthar Gel
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Biopharmaceutical company Mallinckrodt plc (NYSE:MNK) disclosed on Monday that it has admitted the first patient under its Phase 4 clinical study assessing the efficacy and safety of H.P. Acthar Gel (repository corticotropin injection) in rheumatoid arthritis (RA) patients with persistently active disease.
The company said H.P. Acthar Gel is approved by the US Food and Drug Administration (FDA) for use as adjunct therapy for short-term administration in RA to tide the patient over an acute episode or exacerbation. H.P. Acthar Gel is an injectable drug for the treatment of 19 indications.
This multicentre two part Phase 4 trial will assess the efficacy and safety of the company 's H.P. Acthar Gel in 230 subjects with rheumatoid arthritis with persistently active disease.
In conjunction with the trial, the primary endpoint of the study is to evaluate H.P. Acthar Gel treatment response, as measured by the DAS28-ESR (Disease Activity Score with 28 joint count and erythrocyte sedimentation rate) at week 12. Subjects who achieve low disease activity will enter a 12-week, double-blind randomised maintenance period, added the company.
RA is reportedly an autoimmune disease that causes pain, stiffness, and swelling of the joints--all symptoms caused by inflammation.
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|Date:||Nov 15, 2016|
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