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Momenta (MNTA) Up on Positive Data From Generalized MG Drug
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Shares of Momenta Pharmaceuticals, Inc. gained 14% after it announced positive top-line data from an interim analysis of its mid-stage study on nipocalimab (M281), a high-affinity, fully-human, aglycosylated, effectorless IgG1 anti-FcRn monoclonal antibody.
The multicenter, randomized double-blind, placebo-controlled study, Vivacity-MG, is evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab in 68 patients with moderate-to-severe generalized myasthenia gravis (gMG).
The 8-week treatment period included four active arms (5 mg/kg every 4 weeks, 30 mg/kg every 4 weeks, 60 mg/kg every two weeks and a 60 mg/kg single dose) and one placebo arm.
Results showed that all four treatment arms demonstrated efficacy in the myasthenia gravis activities of daily living (MG-ADL) score. The study met its primary endpoint with a strong relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit. Additionally, all dosing arms showed strong safety and tolerability profiles.
The study is expected to be completed in the third quarter of 2020. Momenta plans to present the 16-week data with analysis of secondary endpoints and importantly, the duration of efficacy in the fourth quarter of 2020.
The company has begun preparations to conduct the end of phase II meetings with regulatory agencies before the end of 2020.
The successful development and commercialization of the drug will be a significant boost for Momenta.
Meanwhile, nipocalimab is also being evaluated in two ongoing studies — the Energy Study and Unity. The Energy Study is the company’s adaptive phase II/III trial of nipocalimab in warm autoimmune hemolytic anemia (wAIHA). Momenta is activating clinical sites globally and expects to reinitiate patient enrollment in the fourth quarter of 2020. Nipocalimab has been granted Fast Track and Orphan Drug designations by the FDA in this indication. Unity is evaluating nipocalimab in hemolytic disease of the fetus and newborn (HDFN).
This phase II study is ongoing and actively enrolling patients.
Momenta’s stock has surged 88.8% in the year so far compared with the industry’s growth of 7%.
Stiff competition from Mylan adversely impacted Momenta’s business.
The company has now decided to focus on the discovery and development of novel drugs to treat rare, immune-mediated disorders.
The company has also narrowed its focus on biosmilars and is currently developing a biosimilar of Regeneron’s (REGN - Free Report) Eylea in collaboration with Mylan.
Alexion’s Soliris is approved for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AchR) antibody positive.
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.1% per year.
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Momenta (MNTA) Up on Positive Data From Generalized MG Drug
Shares of Momenta Pharmaceuticals, Inc. gained 14% after it announced positive top-line data from an interim analysis of its mid-stage study on nipocalimab (M281), a high-affinity, fully-human, aglycosylated, effectorless IgG1 anti-FcRn monoclonal antibody.
The multicenter, randomized double-blind, placebo-controlled study, Vivacity-MG, is evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab in 68 patients with moderate-to-severe generalized myasthenia gravis (gMG).
The 8-week treatment period included four active arms (5 mg/kg every 4 weeks, 30 mg/kg every 4 weeks, 60 mg/kg every two weeks and a 60 mg/kg single dose) and one placebo arm.
Results showed that all four treatment arms demonstrated efficacy in the myasthenia gravis activities of daily living (MG-ADL) score. The study met its primary endpoint with a strong relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit. Additionally, all dosing arms showed strong safety and tolerability profiles.
The study is expected to be completed in the third quarter of 2020. Momenta plans to present the 16-week data with analysis of secondary endpoints and importantly, the duration of efficacy in the fourth quarter of 2020.
The company has begun preparations to conduct the end of phase II meetings with regulatory agencies before the end of 2020.
The successful development and commercialization of the drug will be a significant boost for Momenta.
Meanwhile, nipocalimab is also being evaluated in two ongoing studies — the Energy Study and Unity. The Energy Study is the company’s adaptive phase II/III trial of nipocalimab in warm autoimmune hemolytic anemia (wAIHA). Momenta is activating clinical sites globally and expects to reinitiate patient enrollment in the fourth quarter of 2020. Nipocalimab has been granted Fast Track and Orphan Drug designations by the FDA in this indication. Unity is evaluating nipocalimab in hemolytic disease of the fetus and newborn (HDFN).
This phase II study is ongoing and actively enrolling patients.
Momenta’s stock has surged 88.8% in the year so far compared with the industry’s growth of 7%.
Stiff competition from Mylan adversely impacted Momenta’s business.
The company has now decided to focus on the discovery and development of novel drugs to treat rare, immune-mediated disorders.
The company has also narrowed its focus on biosmilars and is currently developing a biosimilar of Regeneron’s (REGN - Free Report) Eylea in collaboration with Mylan.
Alexion’s Soliris is approved for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AchR) antibody positive.
Momenta currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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