MoonLake Immunotherapeutics in-licenses potentially best-in-class Tri-specific Nanobody®,[6] Sonelokimab (M1095/ALX 0761) from Merck KGaA, Darmstadt, Germany, with goal of transforming treatment of inflammatory diseases driven by IL-17A and F

- Clinically demonstrated efficacy and "pipeline within a product" potential to drive disease modification in dermatology and rheumatology patients with major unmet need

- Planned acceleration of clinical development program in multiple indications, building on unique data set from Merck KGaA, Darmstadt, Germany, and Ablynx

- MoonLake Immunotherapeutics led by internationally experienced immunology specialists and backed by lead investor BVF Partners LP

ZUG, Switzerland, May 3, 2021 /PRNewswire/ -- MoonLake Immunotherapeutics AG, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory skin and joint diseases, today announced that it has in-licensed the Tri-specific Nanobody^® Sonelokimab (M1095/ALX 0761) from Merck KGaA, Darmstadt, Germany.

MoonLake Immunotherapeutics has been established by an international team of immunology specialists to leverage revolutionary Nanobody^® (single-domain antibody) technology in multiple indications.  It will accelerate the clinical development of Sonelokimab, building on robust clinical data generated by Merck KGaA, Darmstadt, Germany, and by Ablynx, a Sanofi company, which discovered the molecule.  Sonelokimab has clinically demonstrated potential to drive disease modification in dermatology and rheumatology patients.  Sonelokimab is a Tri-specific, balanced IL-17A/F inhibitor with an albumin binding site, which has the potential to facilitate deep tissue penetration in the skin and joints¹.

Kristian Reich MD, PhD, Chief Scientific Officer and co-founder of MoonLake Immunotherapeutics, commented: "Sonelokimab is a remarkable Nanobody with game-changing potential in the treatment of a range of IL-17A/F-driven inflammatory diseases.  As a dermatologist with over 25 years of experimental and clinical experience in immunology, I believe MoonLake Immunotherapeutics has a unique opportunity to build on the excellent development work of Merck KGaA and Ablynx.  Our goal is to unlock the full potential of Sonelokimab, giving millions of patients with skin and joint diseases a chance of better disease control."

Spike Loy, Managing Director of BVF Partners LP, commented: "We believe the expert immunology team at MoonLake Immunotherapeutics has the depth and breadth of experience to ensure Sonelokimab achieves its full potential in a range of inflammatory skin and joint diseases, where there is substantial need for new treatment options.  Building on positive Phase 2 data, we look forward to MoonLake Immunotherapeutics rapidly bringing this promising new therapy to patients."

Sonelokimab was previously studied in a robust Phase 2b clinical trial in n=313 moderate-to-severe psoriasis patients.  Sonelokimab showed impressive efficacy and safety, and numerically outperformed active control secukinumab.  Secukinumab is marketed under the trade name Cosentyx^® by Novartis.  The study highlights Sonelokimab's promise as a treatment of inflammatory diseases where the cytokines IL-17A and IL-17F play a major role.  Results from this study were the subject of a late breaker presentation at the European Academy of Dermatology and Venereology (EADV) Congress in October 2020.

MoonLake Immunotherapeutics plans to accelerate the development of Sonelokimab in multiple inflammatory diseases in dermatology and rheumatology driven by IL-17A and IL-17F.  This group of IL-17A/F Inflammatory Diseases (introducing the novel concept of AFID) include psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa – conditions affecting millions of people worldwide with a large need for improved treatment options.  MoonLake Immunotherapeutics plans to initiate multiple Phase 2 trials soon.

MoonLake Immunotherapeutics AG was founded in 2021, backed by a Series A financing led by BVF Partners LP.  Other investors include Merck KGaA, Darmstadt, Germany.  The Company has been founded by a highly expert executive leadership team with decades of experience in immunology, including discovery, clinical development, regulatory affairs, product launch, commercialization & business development.  The team includes:

• Arnout Ploos van Amstel MSc. Econ, co-founder and Chief Operating Officer, who has more than 25 years of experience as a global executive leader in biopharma, including at Novartis.
• Prof Kristian Reich MD, PhD, co-founder and Chief Scientific Officer, who has more than 25 years of experience as a global clinical leader in dermatology and immunology.
• Other members of the executive team and Board of Directors will be announced soon.

For enquiries, please contact:

Website: www.moonlaketx.com

For the full announcement please see: www.moonlaketx.com/news/sonelokimab