NM26 is a first-in-class bi-specific antibody designed to simultaneously block multiple targets, targeting the underlying inflammation as well as the neuroinflammatory pathway that causes itch

MAD data expected to be reported in mid-2024; Single ascending dose (SAD) cohort in healthy volunteers remains ongoing

HORGEN, Switzerland I October 19, 2023 I Numab Therapeutics AG (Numab), a clinical stage biotechnology company advancing a proprietary pipeline of immunology and oncology therapeutics, announced today that the first patient has been dosed in the multiple ascending dose (MAD) study of the Phase 1a/b clinical trial of NM26, a first-in-class bi-specific antibody for the treatment of moderate-to-severe atopic dermatitis (AD).

The MAD study in AD patients is a planned continuation of the Company’s ongoing single ascending dose (SAD) portion of the Phase 1a/b trial in healthy volunteers. NM26 is designed to simultaneously block itch and inflammation by inhibiting the three key cytokine-signaling pathways involved in disease pathogenesis of AD: IL-4, IL-13, and IL-31, the latter specifically targeting the neuroinflammatory pathway that causes itch.

“Dosing the first patient with NM26 represents a major milestone for Numab as we advance development of NM26 in atopic dermatitis and potentially other inflammatory and immune-mediated diseases,” said David Urech, Ph.D., Founder and Chief Executive Officer of Numab Therapeutics. “We believe that NM26 has the potential to deliver faster relief from itch and more pronounced improvement of skin lesions than the current standard of care and therefore provide a more effective therapeutic option for patients. We look forward to evaluating the potential of NM26 and expect to report preliminary data from the MAD part of the study in mid-2024.”

AD is an inflammatory skin condition which is characterized by a vicious cycle of skin inflammation that causes itching and scratching, the latter in turn exacerbates damage to the skin barrier and inflammation and furthers itching, resulting in the characteristic skin lesions for which AD is known. In the United States and the European Union markets, approximately 17-26 million patients suffer from moderate-to-severe AD.

The Phase 1a/1b trial is a randomized, double-blind, placebo-controlled study of subcutaneous (SC) administration of NM26 in healthy volunteers and adult patients with moderate-to-severe AD to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple ascending doses of NM26 as well as exploratory clinical activity in the MAD part of the trial. The trial is being conducted in collaboration with Asia-regional partner Kaken Pharmaceutical. For additional information on this trial (NCT05859724), please visit www.clinicaltrials.gov.

About NM26 (NM26-2198)

NM26 is a bi-specific antibody which targets IL-4Rα (type I and type II receptors) and IL-31 for the treatment of atopic dermatitis (AD). The antibody therapeutic is designed to prevent IL- 4/IL-13 and IL-31-induced keratinocyte immunopathology, immune cell activation, skin barrier function impairment and pruritis, all of which are hallmarks of the pathophysiology of atopic dermatitis. Addition of IL-31 mediated blockade of neuroinflammation to the repression of Th2 driven inflammation by IL-4/IL-13 blockade is expected to enable a faster onset of action and demonstrate superior efficacy over current and emerging standard of care in AD, together with convenient subcutaneous administration. Numab is developing this molecule together with its regional partner Kaken Pharmaceutical, which owns commercial rights to certain Asian territories, including Japan.

About Numab Therapeutics

Numab Therapeutics is an immunology and oncology-focused biopharmaceutical company based in Zurich-area, Switzerland. At Numab, we are writing the next chapter in addressing unmet needs in inflammatory diseases and cancer immunotherapy by creating multi-specific antibodies that enable the pursuit of novel therapeutic strategies. With our proprietary MATCH technology platform, we are fueling a new wave of multi-specific drug candidates engineered with versatility and developability in mind. We believe meeting the highest quality standards in every step of the drug design process matters and will result in better patient outcomes. For further information, visit www.numab.com.

About Kaken Pharmaceutical

Kaken is an R&D driven pharmaceutical company, established in 1948, and its corporate philosophy is to help improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals. Recently, Kaken has increased its presence in dermatology and orthopedics, and Clenafin, a drug discovered in-house and first topical onychomycosis treatment in Japan, continues to grow as a global product. For more information, please visit https://www.kaken.co.jp/english/.

SOURCE: Numab Therapeutics