Mallinckrodt Initiates Phase IV Study On Acthar For Keratitis

Mallinckrodt plc (NYSE:MNK) announced the enrollment of the first patient in its phase IV, multi-center, multiple-dose, open-label study to assess the effects of lead drug Acthar Gel as a therapy option in patients with severe keratitis. Keratitis is a painful inflammation of the cornea, which can result in partial or total loss of vision if left untreated.

The study targets to enroll 30 adult subjects to examine the effects of Acthar. Subjects with current severe keratitis, who meet entry criteria, will be treated with Acthar Gel 1 mL subcutaneously (SC) two times per week for 12 weeks. Initial treatment will be followed by a taper to Acthar 1 mL SC once a week for two weeks, then 0.5 mL SC once a week for two weeks.

Label expansion of the drug will boost sales for the company.

Mallinckrodt’s stock has plunged 76.9% in the year so far against the industry’s growth of 6.7%.

We note that Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. It is approved for the 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 and anterior segment inflammation. It is also approved as adjunctive therapy for short-term administration in rheumatoid arthritis (RA), including juvenile RA. Acthar Gel, which became part of the company’s portfolio following the Questcor acquisition, continues to drive growth. Performance of the drug has been impressive so far, propelled by solid demand in rheumatology, pulmonology, ophthalmology and nephrology indications, expanded access in more recently promoted indications such as lupus and sarcoidosis, and mature indications such as infantile spasms and nephrotic syndrome.

Zacks Rank & Stocks to Consider

Mallinckrodt is a Zacks Rank #3 (Hold) stock, currently.

A few better-ranked stocks in the biotech sector are Alkermes Plc. (NASDAQ:ALKS) , Anika Therapeutics Inc. (NASDAQ:ANIK) and Innoviva Inc. (NASDAQ:INVA) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.

Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.

Innoviva’s earnings per share estimates have increased from $1.71 to $2.03 for 2019 and from $1.07 to $1.34 for 2020 in the past 60 days.

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