-No new safety signals were identified with prolonged inebilizumab treatment and inebilizumab-mediated B-cell depletion-
-UPLIZNA was shown to be safe and effective in patients with previous exposure to off-label therapy-
GAITHERSBURG, Md., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Viela Bio (Nasdaq:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for patients suffering from autoimmune and severe inflammatory diseases, today reported updated safety, efficacy and long-term use results of UPLIZNA® (inebilizumab-cdon), including interim data from the open-label extension period (OLP) of the pivotal N-MOmentum trial in patients with neuromyelitis optica spectrum disorder (NMOSD). Data from four scientific abstracts were selected for presentations during the American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2021 Forum, which is being held virtually from February 25-27, 2021.
Among the highlights in patients treated with UPLIZNA® — the first and only FDA-approved B-cell depleter for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD — a reduction of attacks was sustained for the duration of the four-year observation period (with two patients on therapy for more than four years). Consistent with previous clinical results, no new safety signals were observed, regardless of the patient’s prior exposure to off-label therapy.
“Based on data from the OLP, UPLIZNA® demonstrated strong safety and efficacy during the open-label extension for a period of four years, regardless of the patient’s previous treatment with off-label therapy, further supporting the drug’s ability to provide long-term therapeutic benefits to patients with NMOSD,” said Dr. Jorn Drappa, Chief Medical Officer of Viela Bio.
Presentation Details and Data Highlights
Poster title: “The N-MOmentum Trial of Inebilizumab for Neuromyelitis Optica Spectrum Disorder: Long-Term Open Label Efficacy and Safety Update”
Poster number: P144
Presenter: Bruce Cree, M.D., Ph.D., MAS, lead investigator for the N-MOmentum study and Professor of Clinical Neurology at the University of California San Francisco Weill Institute for Neurosciences
Summary of results:
Of the 230 patients randomized and dosed in the N-MOmentum study, 216 entered the OLP with 165/174 (94.8%) of those originally randomized to inebilizumab (RI) and 51/56 (91.1%) originally randomized to placebo (RP);
Attack Risk During the OLP
○ A sustained, long-term effect on attack risk was observed during the OLP
○ Fewer attacks occurred following prolonged treatment exposure. The proportions remaining attack-free were:
▪ RI group: 96.3% at 6 months, 92.6% at 1 year and 87.7% at over 4 years
▪ RP group: 86.0% at 6 months, 83.6% at 1 year and 83.4% at over 4 years
▪ Any inebilizumab group (as defined by all participants who received inebilizumab at any point during the study): 88.3% at 6 months, 84.5% at 1 year and 80.0% at over 4 years
Treatment-emergent adverse events (TEAEs) in the OLP
○ TEAE incidences per person-year in the OLP were 2.51 (RI) and 3.05 (RP)
○ Infusion-related reactions occurred in 5.5% of RI and 13.7% of RP participants, compared with 11.6% in the RCP
○ Two participants in the OLP died: one from complications of a severe NMOSD attack and the other from a CNS event of unclear etiology
No new safety signals were identified with prolonged inebilizumab treatment and
inebilizumab-mediated B-cell depletion
○ Common TEAEs were similar in the RCP and OLP periods
○ Rates of infection or serious infection did not increase with prolonged inebilizumab treatment
○ No correlation between rates of infections and concentrations of IgG or IgM were observed
Poster title: “The Safety and Efficacy of Inebilizumab in Those with Previous Rituximab Exposure”
Poster number: P145
Presenter: Michael Levy, Viela Bio
Summary of results:
17 subjects enrolled in the N-MOmentum study (7.4%) had previous rituximab treatment
○ The median time between the last rituximab use and randomization was 1.5 years
○ 3 of the 17 participants had attacks on inebilizumab, 1 during the RCP and 2 in the open-label phase
Compared with the rest of the inebilizumab treated group, prior rituximab exposure did not impact efficacy
○ The AAR for those with and without prior rituximab exposure was .083 and .102, respectively:
○ 7 of 17 patients entered the study as rituximab ‘failures’, defined as having an NMOSD attack while on (or within 6 months) of the last dose of rituximab. None of the 7 failures had an adjudicated attack after receiving inebilizumab (mean follow-up 2.6 years)
○ Adverse events of interest in this group included infusion reaction (2), infections (16), and cytopenia (1)
○ No opportunistic infections occurred
Summary of Additional Poster Presentations
Poster Title: “Evaluation of Infusion Reactions and Infusion Times in the N-MOmentum Study of Inebilizumab for NMOSD”
Poster Number: P138
Presenter: Mark Tullman, Viela Bio
Summary of Results: Infusion-related reactions in patients were generally mild and no unexpected safety concerns were identified during continued dosing.
Poster Title: “Immunoglobin Kinetics and Infection Risk After Long-Term Inebilizumab Treatment for NMOSD”
Poster Number: P139
Presenter: Benjamin Greenberg
Summary of Results: With continued use of UPLIZNA®, a decrease in immunoglobin levels was observed over time, which was not associated with increased rate of infections.
About Neuromyelitis Optica Spectrum Disorders (NMOSD)
NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal. Approximately 80% of all patients with NMOSD test positive for anti-AQP4 antibodies.
These AQP4 autoantibodies bind primarily to astrocytes in the central nervous system and initiate a cascade of events that lead to neurons damage and the clinical manifestation of NMOSD attack. Commonly, the optic nerve and spinal cord are the sites of NMOSD attack with rare involvement of brain and brainstem. Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure can all be manifestations of the disease. Each NMOSD attack can lead to further damage and disability. NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent.
N-MOmentum, the largest clinical study ever conducted in NMOSD, was a double-blind, placebo-controlled clinical trial of 213 patients who are anti-AQP4 antibody positive and 17 who are anti-AQP4 antibody negative (n=230). In the randomized controlled phase, patients were randomized to receive two intravenous doses of UPLIZNA® (inebilizumab-cdon) monotherapy or placebo and followed for 6.5 months. Patients were subsequently given the option to enter into an open-label extension in which all patients receive inebilizumab every 6 months. The primary endpoint was time from treatment initiation to occurrence of an NMOSD attack, which was reviewed and confirmed by an independent, blinded external Adjudication Committee. NMOSD attack diagnosis was standardized using 18 clinically meaningful criteria that were developed for the study. The study was completed in November of 2020 with open label follow-up of 2->4 years. More information can be found on clinicaltrials.gov (Study NCT02200770).
IMPORTANT SAFETY INFORMATION
UPLIZNA® is contraindicated in patients with:
A history of life-threatening infusion reaction to UPLIZNA®
Active hepatitis B infection
Active or untreated latent tuberculosis
WARNINGS AND PRECAUTIONS
Infusion Reactions: UPLIZNA® can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.
Infections: The most common infections reported by UPLIZNA® -treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA® administration in patients with an active infection until the infection is resolved.
Increased immunosuppressive effects are possible if combining UPLIZNA® with another immunosuppressive therapy.
The risk of hepatitis B virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA®. Do not administer to patients with active hepatitis.
Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA® clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA® and perform an appropriate diagnostic evaluation.
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA®.
Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.
Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA® treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA® until B-cell repletion especially in patients with opportunistic or recurrent infections.
Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA®.
Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA® and greater than placebo) were urinary tract infection and arthralgia.
About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for patients suffering from autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans, objectives of management; our expectations regarding the commercialization of UPLIZNA®; our belief that UPLIZNA® provides prescribing physicians an important new treatment option for patients living with NMOSD; our belief that UPLIZNA® could reduce attacks which can lead to devastating and irreversible disability in patients living with NMOSD; our estimate of the number of people in the U.S. suffering from NMOSD; our estimate of the percentage of patients with NMOSD that test positive for anti-AQP4 antibodies; statements regarding the timing and potential approval of UPLIZNA® in countries outside the United States; potential benefits of UPLIZNA®; our expectations regarding the availability of UPLIZNA®; the commercialization and market acceptance of UPLIZNA®; and our expectations about sufficiency of our existing cash balance and the anticipated impact of the COVID-19 pandemic on our commercialization efforts, business, operations and clinical trials are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various factors may cause differences between our expectations and actual results as discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including without limitation, the risks and uncertainties described in the section entitled “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2019 that was filed with the SEC on March 25, 2020 and our subsequent periodic and current reports filed with the SEC. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Source: Viela Bio