STAINES-UPON-THAMES, United Kingdom Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed enrollment of the first patient in the company’s Phase 4 pilot study assessing the efficacy of H.P. Acthar® Gel (repository corticotropin injection) for the management of exacerbations of relapsing and remitting multiple sclerosis (RRMS) in patients whose relapse symptoms have not responded to a course of high-dose corticosteroids.
“Some MS patients may have relapse symptoms that don’t resolve with steroid therapy, and in my experience, H.P. Acthar Gel may provide benefit in these cases,” said Aaron Miller, M.D., a program advisor and participating site investigator from the Icahn School of Medicine at Mount Sinai in New York. “This study is an important step to confirming the appropriate patient type for this product as an approved and appropriate treatment for MS exacerbations.”
H.P. Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for treatment of acute exacerbations of multiple sclerosis in adults.
“Mallinckrodt is committed to providing alternative treatment options to patients who need them,” said Steven Romano, M.D., Chief Scientific Officer and Executive Vice President at Mallinckrodt. “Clinical experience and current labeling support the use of Acthar to speed recovery from relapses in MS. We are pleased to enroll the first patient in the OPTIONS trial to better understand the patients who will benefit from Acthar therapy, and to support its role in the management of RRMS.”
About the OPTIONS Trial
The Phase 4 clinical study is titled “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar Gel in Subjects With Relapsing-Remitting Multiple Sclerosis”. The study will enroll patients with MS relapses of moderate severity and symptoms that have not adequately improved following a typical course of high dose IV or oral corticosteroid therapy, then randomize them to receive additional treatment with H.P. Acthar Gel or placebo in blinded fashion.
Improvement in relapse symptoms will be assessed using several standard MS disease activity measures, including the Expanded Disability Status Scale (EDSS), MS Impact Scale (MSIS-29), and Clinical Global Impressions-Improvement Scale (CGI-I). Because this trial targets only a subset of RRMS patients experiencing relapses who have not responded acutely to corticosteroid therapy, the study may take a number of years to recruit.
Find more information about the OPTIONS trial here on the ClinicalTrials.gov website.
MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).1 Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes. More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.2
About H.P. Acthar® Gel (repository corticotropin injection)
H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of H.P. Acthar Gel use is in these indications:
- As an orphan monotherapy medication for the treatment of IS in infants and children under 2 years of age.
- Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
- Treatment of acute exacerbations of multiple sclerosis in adults.
- Use during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.
- Use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).
- Use as adjunct therapy for short-term administration in select cases of rheumatoid arthritis, to tide patients over an acute episode or exacerbation.
- Treatment of symptomatic sarcoidosis.
- Treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis; iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis; anterior segment inflammation.
For more information about Acthar, please visit www.acthar.com.