AsiaNet  85540

DARMSTADT, Germany, September 11, 2020, /PRNewswire=KYODO JBN/--

In MAGNIFY-MS, patients experienced a rapid onset of action from end of Month 1

that was significant in all study periods versus baseline

Post-approval safety analysis showed no increased risk of viral respiratory

infections and lower rates of malignancy than in the clinical trial program

Data from MAVENCLAD-treated patients with confirmed or suspected COVID-19

suggest no increased risk of severe outcomes

Merck, a leading science and technology company, today announced the

presentation of new efficacy data from the Phase IV MAGNIFY-MS study on

MAVENCLAD(R) (cladribine tablets) in patients with relapsing multiple sclerosis

(RMS) which showed a rapid onset of action from end of Month 1 supported by

changes in combined unique active (CUA) magnetic resonance imaging (MRI)

lesions. The data also showed a significant reduction in mean T1

gadolinium-enhancing (Gd+) lesion counts.

"The MAGNIFY-MS results presented at ACTRIMS-ECTRIMS 2020 further substantiate

the ability of MAVENCLAD to deliver early efficacy in patients with RMS," said

Prof. Nicola De Stefano, PhD, Professor of Neurology, Department of Medicine,

Surgery and Neuroscience, University of Siena, Italy. "Knowing we can provide

patients with a treatment option we feel confident can start working quickly

and maintain efficacy over a longer period of time without the need for

additional treatment or frequent monitoring is very exciting for the MS

community."  

In the MAGNIFY-MS study, MRI lesions at baseline were compared over three time

periods – Months 1–6, 2–6 and 3–6 of treatment. Data showed a rapid onset of

action from end of Month 1, with CUA lesion counts significantly reduced in all

study periods versus baseline (61% reduction for Months 1–6; 77% reduction for

Months 2–6; 87% reduction for Months 3–6). Further, mean T1 Gd+ lesion counts,

in particular, were significantly decreased from Month 2 onwards compared to

baseline.

Additionally, updated post-approval safety data was presented based on an

analysis of the first 18,463 patients who received MAVENCLAD post-approval, as

of July 2020. The safety database analysis also provided a look at findings

from 46 cases of confirmed or suspected COVID-19 in MAVENCLAD-treated patients

(18 and 28, respectively), suggesting that patients treated with MAVENCLAD who

acquire COVID-19 are not at an increased risk of severe outcomes. Data

specifically showed the majority of patients had mild-to-moderate respiratory

symptoms. Four patients were hospitalized and there were no deaths. Additional

data on clinical outcomes in patients with COVID-19 infection will be available

as part of the late-breaking and COVID-19 sessions from 25 September.

"The data presented exemplify our passion to dig deeper into MS research,

continuing to learn more about how our existing treatments can impact those

living with the disease, especially as they navigate MS management in the midst

of a pandemic," said Luciano Rossetti, Head of Global Research & Development

for the biopharma business of Merck. "We now have evidence showing an early

onset of action and real-world data supporting the clinical trial findings that

MAVENCLAD does not increase the risk of viral respiratory infections."

Based on the analysis presented at the congress, rates of viral respiratory

infections were low and typically non-serious; the pattern was consistent with

that from the clinical development program. Crude incidences were: influenza,

0.68%; viral infection, 0.27%; and viral upper respiratory tract infection,

0.04%. The crude incidence rate of malignancy was much lower than that observed

in the clinical trial program.

About MAVENCLAD(R)

MAVENCLAD(R) is a short-course oral therapy that selectively and periodically

targets lymphocytes thought to be integral to the pathological process of

relapsing MS (RMS). In August 2017, the European Commission (EC) granted

marketing authorization for MAVENCLAD(R) for the treatment of relapsing forms

of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in

addition to Norway, Liechtenstein and Iceland. MAVENCLAD(R) has since then been

approved in 79 countries, including Canada, Australia and the U.S. Refer to the

respective prescribing information for further details.

The clinical development programme for cladribine tablets includes:

The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III

placebo-controlled study designed to evaluate the efficacy and safety of

cladribine tablets as a monotherapy in patients with RRMS.

The CLARITY extension study: a Phase III placebo-controlled study following on

from the CLARITY study, which evaluated the safety and exploratory efficacy of

cladribine tablets over two additional years beyond the two-year CLARITY study,

according to the treatment assignment scheme for years 3 and 4.

The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III

placebo-controlled study designed to evaluate the efficacy and safety of

cladribine tablets as a monotherapy in patients at risk of developing MS

(patients who have experienced a first clinical event suggestive of MS).

The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With

Active Relapsing Disease) study: a Phase II placebo-controlled study designed

primarily to evaluate the safety and tolerability of adding cladribine tablets

treatment to patients with relapsing forms of MS, who have experienced

breakthrough disease while on established interferon-beta therapy.

PREMIERE (Prospective Observational Long-term Safety Registry of Multiple

Sclerosis) study: a long-term observational follow-up safety registry of MS

patients who participated in cladribine tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in

patients treated with cladribine tablets was lymphopenia (26.7% with cladribine

tablets and 1.8% for placebo). The incidence of infections was 48.3% with

cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively

rated mild-to-moderate by investigators. Adverse Events reported in other

clinical studies were similar.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central

nervous system and is the most common non-traumatic, disabling neurological

disease in young adults. It is estimated approximately 2.3 million people have

MS worldwide. While symptoms can vary, the most common symptoms of MS include

blurred vision, numbness or tingling in the limbs and problems with strength

and coordination. The relapsing forms of MS are the most common.

Merck in Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant

R&D and commercial experience in multiple sclerosis (MS). The company`s current

MS portfolio includes two products for the treatment of relapsing MS, with a

robust pipeline focusing on discovering new therapies that have the potential

to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of

those living with MS, by addressing areas of unmet medical needs.

The company's robust immunology pipeline focuses on discovering new therapies

that have the potential to modulate key pathogenic mechanisms in chronic

diseases such as MS, systemic lupus erythematosus and psoriasis.

All Merck Press Releases are distributed by email at the same time they become

available on the Merck Website. Please go to www.merckgroup.com/subscribe to

register online, change your selection or discontinue this service.

About Merck

Merck, a leading science and technology company, operates across healthcare,

life science and performance materials. Around 57,000 employees work to make a

positive difference to millions of people's lives every day by creating more

joyful and sustainable ways to live. From advancing gene editing technologies

and discovering unique ways to treat the most challenging diseases to enabling

the intelligence of devices – the company is everywhere. In 2019, Merck

generated sales of  16.2 billion Euros in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to

Merck's technological and scientific advances. This is how Merck has thrived

since its founding in 1668. The founding family remains the majority owner of

the publicly listed company. Merck holds the global rights to the Merck name

and brand. The only exceptions are the United States and Canada, where the

business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma

in life science, and EMD Performance Materials.

(Logo: https://mma.prnewswire.com/media/1136775/Merck_Logo.jpg)

Contact:

tone-brauti.fritzen@merckgroup.com

+49 151 1454 2694

SOURCE: Merck