Investor Alert

June 15, 2020, 7:05 a.m. EDT

Momenta Pharmaceuticals Announces Positive Topline Data from Interim Analysis of Phase 2 Vivacity-MG Study of Nipocalimab (M281) in Generalized Myasthenia Gravis (gMG)

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CAMBRIDGE, Jun 15, 2020 (GLOBE NEWSWIRE via COMTEX) -- - Trial met primary endpoint with a strong relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit (p<0.0001) -

- Nipocalimab induced a rapid and durable response in the myasthenia gravis activities of daily living score (MG-ADL) at all doses -

- Nipocalimab was well tolerated, with no adverse events leading to discontinuation -

- Company to host a conference call today at 8:30 a.m. EST -

Momenta Pharmaceuticals, Inc. /zigman2/quotes/200094979/composite MNTA +1.82% , a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today announced positive topline data from an interim analysis of its Phase 2 Vivacity-MG study of nipocalimab (M281) in generalized myasthenia gravis (gMG). All four treatment arms showed efficacy in the myasthenia gravis activities of daily living (MG-ADL) score, the primary endpoint. Additionally, all dosing arms showed strong safety and tolerability profiles.

"We are thrilled with the success of nipocalimab's proof of concept trial in MG. We met our primary endpoint in this trial, demonstrating rapid and durable responses in all 4 dosing arms and a significant correlation between IgG reduction and efficacy," said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "The data we are sharing today continues to build the evidence that nipocalimab has the potential to be a best-in-class agent in terms of efficacy, safety and dosing. Thank you to the patients, families and researchers who made this study possible, especially during the COVID-19 pandemic. We look forward to sharing the full data set later this year at a medical conference and discussing our phase 3 plans as we work to bring forward what we hope will be the best in class FcRn agent."

Study Design

The Vivacity-MG study, initiated April 2019, is a Phase 2, multicenter, randomized double-blind, placebo-controlled study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab in 68 patients with moderate-to-severe generalized MG (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. The primary endpoint of the study was to reach statistically significant change from the baseline score of the myasthenia gravis Activities of Daily Living (MG-ADL) score.

Key Study Results

-- 52% of patients who received nipocalimab had rapid, significant and durable reductions in MG-ADL scores (at least a 2-point reduction from baseline for at least 4 consecutive weeks) across all four dosing arms, versus 15% of placebo treated patients (p=0.017)

-- A statistically significant relationship was observed between IgG reduction and clinical benefit for patients taking nipocalimab (p<0.0001)

-- Patients across all four nipocalimab dosing arms showed rapid reductions in MG-ADL scores, with clinically meaningful changes from baseline within two weeks

-- Nipocalimab (M281) was well tolerated, safe and efficacious in gMG patients. There were no severe or serious nipocalimab-related adverse events and most adverse events were characterized as mild

-- The study findings support continued clinical development in gMG and subcutaneous formulation dose selection.

The study is expected to be completed in the third quarter of 2020. The Company plans to present the 16-week data with analysis of secondary endpoints and importantly, duration of efficacy, in the fourth quarter 2020.

"We're pleased to unveil positive topline interim results from our Phase 2 study in gMG which demonstrates our deep understanding of the clinical relationship between IgG reduction and efficacy of nipocalimab in alleviating the debilitating symptoms of gMG," said Santiago Arroyo, M.D., Ph.D., Chief Medical Officer of Momenta Pharmaceuticals.

"The knowledge we have gained from this multi-arm dosing study serves as a roadmap to design a Phase 3 study focused on dosing precision and flexibility, and ultimately for physicians to better understand the onset of action and duration of effect for their gMG patients."

"For patients with myasthenia gravis, current treatment options include medications such as acetylcholinesterase inhibitors, corticosteroids and immunosuppressants which may provide improvement in muscle strength; however, many patients fail to respond, have substantial side effects or have uncontrolled disease symptoms that limit their daily function and quality of life. The promise of nipocalimab to reduce pathogenic autoantibodies in a dose dependent manner, brings me great hope in providing these patients with a new treatment option," said Jeffrey T Guptill, M.D., Principal Investigator. "The correlation between IgG reduction and symptom control across all doses in the nipocalimab trial may provide physicians the ability to optimally adjust patient dosing," he added.

Based on the data, the Company has begun preparations to conduct end of Phase 2 meetings with regulatory agencies before the end of 2020.

Management will host a conference call today at 8:30 a.m. ET to discuss these results. To access the call, please dial (833) 714-0880 (domestic) or +1 (778) 560-2636 (international) prior to the scheduled conference call time and provide the conference ID 7997563. A live webcast of the call will be available on the "Investors" section of the company's website, www.momentapharma.com . An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

About Generalized Myasthenia Gravis (gMG)

US : U.S.: Nasdaq
$ 32.99
+0.59 +1.82%
Volume: 869,317
Aug. 7, 2020 4:00p
P/E Ratio
Dividend Yield
Market Cap
$3.88 billion
Rev. per Employee
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