PR85512

DARMSTADT, Germany, Sept. 10, 2020 /PRNewswire=KYODO JBN/ --

Not intended for UK and US based media

- Sonelokinab is an investigational IL-17 A/F Nanobody®, which neutralizes both

IL-17A and IL-17F

- Phase II study was facilitated by Avillion as part of an innovative

co-development model

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

top-line results from a Phase II study of sonelokinab (M1095), an

investigational anti-IL-17 A/F Nanobody(R), which neutralizes both IL-17A and

IL-17F, in patients with moderate to severe chronic plaque-type psoriasis.

Currently there are no approved IL-17 A/F nanobodies. The Phase II study was

completed through a co-development agreement with Avillion, first announced in 2017.

"This Phase II study was conducted by Avillion as part of an innovative

co-development model and we thank them for their partnership and successful

completion of this trial with high quality data," said Luciano Rossetti, Head

of Global Research & Development for the biopharma business of Merck.

"Given the encouraging Phase II results we will explore partnership options to

rapidly deliver this promising new therapy to patients living with psoriasis."

The randomized, double-blind, placebo controlled, multi-centre, Phase IIb study

was designed to assess efficacy, safety, and tolerability of sonelokinab in

subjects with moderate to severe chronic plaque-type psoriasis. The trial

enrolled 313 patients (age 18-75) with chronic plaque psoriasis for at least

six months, with an Investigator Global Assessment (IGA) score ≥ 3,

involved body surface area ≥ 10%, and Psoriasis and Severity Index (PASI)

 ≥ 12 at screening and at baseline. Patients were randomized to one of four

dose regimens of sonelokinab, or a placebo comparator arm, or a reference arm

(secukinumab). The study met its primary endpoint of IGA response of at least 2

points reduction from baseline, and secondary endpoints of PASI with high

statistical significance (p<0.001). The data are being prepared for

presentation at an upcoming international conference and for publication in a

peer-reviewed medical journal.

"The Phase II study results for sonelokinab provide valuable insights. The

onset of action and potential durable response of sonelokinab in psoriasis

patients merits further characterization in a comprehensive Phase III program,"

said Kim Papp, MD, PhD, FRCPC, Primary Investigator.

Merck acquired full, exclusive rights to the anti-IL-17 A/F Nanobody(R) through

a global development and commercialization deal with Ablynx (now Ablynx, a

Sanofi Company) in 2013.

About sonelokinab (M1095)

The anti-IL-17 A/F Nanobody(R) sonelokinab is an investigational bi-specific

half-life-extended Nanobody that is thought to neutralise both IL-17A and

IL-17F with the potential to treat inflammatory diseases, including psoriasis.

Currently there are no approved IL-17 A/F nanobodies. Merck acquired full,

exclusive rights to the anti-IL-17 A/F Nanobody(R) through a global development

and commercialization deal with Ablynx (now Ablynx, a Sanofi Company) in 2013.

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 and systemic lupus erythematosus.

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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 Euro 16.2 billion 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.

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For further information, please contact:  

tone-brauti.fritzen@merckgroup.com  

+49 151 1454 2694

Source:  Merck