Mallinckrodt plc MNK announced that it has enrolled the first patient in a phase IIa study on its investigational oral drug MNK-6106 (L-ornithine phenylacetate) for treating hepatic (liver) cirrhosis and hepatic encephalopathy (HE).
The mid-stage study is evaluating the pharmacokinetics, pharmacodynamics and safety of oral MNK-6106 compared with Xifaxan (rifaximin) for addressing the given patient population. The endpoints of the study are to see the absolute and percentage change in plasma ammonia from baseline within a period of baseline to day five.
Mallinckrodt expects to complete the study by the first quarter of 2020.
Notably, in December 2017, Mallinckrodt acquired the privately held biopharmaceutical company Ocera Therapeutics, Inc. for approximately $42.4 million. Following this, the company bought Ocera’s primary development product MNK6106 and the investigational intravenous drug MNK-6105.
The oral formulation — MNK-6106 — is an ammonia scavenger, which is being developed for the treatment of HE, a complicated acute or chronic liver disease. If approved, the candidate may have the potential to reduce the risk of recurrent HE episodes and rehospitalization for such patients.
Mallinckrodt also plans to start recruiting subjects by this year-end in a phase III clinical study on MNK-6105 for treating patients with acute HE.
Shares of Mallinckrodt have plunged 69.5% so far this year, underperforming the industry’s decrease of 7.5%.
We would like to remind investors that Mallinckrodt is striving hard to diversify its portfolio. In May, the company completed enrolling patients in a late-stage study on its pipeline candidate terlipressin, which is being developed for the treatment of Hepatorenal Syndrome type 1 (HRS 1).
Top-line data from the study is expected in the next three months. Mallinckrodt plans to file a new drug application (NDA) in early 2020, if results from the analysis are found to be supportive.
Another late-stage program on its investigational regenerative skin tissue, StrataGraft, is under phase III development for the treatment of deep partial thickness burns and in phase II stage for full thickness burns.
If approved, these should drive the company’s long-term growth.
Zacks Rank & Stocks to Consider
Mallinckrodt currently carries a Zacks Rank #3 (Hold). Better-ranked stocks from the healthcare sector include ProQR Therapeutics N.V. PRQR, Celldex Therapeutics, Inc. CLDX and Compugen Ltd. CGEN, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
ProQR Therapeutics’ loss per share estimates have been narrowed 3% for 2019 and 4.9% for 2020 over the past 60 days.
Celldex’s loss per share estimates have been narrowed 17.1% for 2019 and 8.7% for 2020 over the past 60 days.
Compugen’s loss per share estimates have been narrowed 16.7% for 2019 and 16.3% for 2020 over the past 60 days. The stock has soared 66.3% so far this year.
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