Mallinckrodt Reports Acthar Gel Data on Nephrotic Syndrome - Analyst Blog
Mallinckrodt plc MNK reported two separate presentations by independent physicians on patients treated with H.P. Acthar Gel.
The presentations showed that Achtar led to positive outcomes in the remission of proteinuria, or excess protein in the urine, caused by nephrotic syndrome (NS) associated with certain rare but serious kidney disorders.
On a retrospective case series, the first presentation included nine patients suffering from IgA nephropathy, membranous lupus nephritis or minimal change disease, who were treated with Achtar for at least six months.
Nearly 80% of these patients showed proteinuria reduction of 30% or more from baseline, ranging from 36.4% to 99.4% post-treatment. Among these, two patients showed complete response, four had a partial response, and one had a clinically meaningful response, as measured by criteria from the American Society of Nephrology.
The results showed that Acthar was generally well tolerated, although one patient had an early termination of treatment due to weight gain and hypertension.
Separately, in nine of the 13 patients who completed at least six months of treatment with Acthar, 66.7% showed proteinuria reduction of 37% or greater, with a range of proteinuria reduction from 37.3% to 99.4%. Out of these, one patient showed a complete remission of proteinuria, four showed partial remission, while one had a clinically meaningful response. However, three patients had early termination of treatment due to side effects, including increased swelling, weight gain, and hypertension.
We remind investors that Acthar became part of the company’s portfolio following the Questcor acquisition. The drug is currently approved for 19 indications. Mallinckrodt is currently working on developing Acthar in the indications of lupus, proteinuria, NS, amyotrophic lateral sclerosis and diabetic nephropathy. The label expansion of the drug will further boost sales.
Mallinckrodt currently carries a Zacks Rank #1 (Strong Buy). Other favorably-ranked stocks in the health care sector include Actavis ACT, Akorn, Inc. AKRX and Salix Pharmaceuticals SLXP. All three carry the same Zacks Rank as Mallinckrodt.
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