NM26-2198 is a first-in-class bi-specific antibody designed to simultaneously block multiple targets for the treatment of moderate to severe atopic dermatitis (AD)

Combined single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a/1b clinical study to be conducted in collaboration with Asia-regional partner Kaken Pharmaceutical

Numab Therapeutics AG (Numab), a clinical stage biotechnology company advancing a proprietary pipeline of immunology and oncology therapeutics, announced today that the first subject has been dosed in the Phase 1 clinical study of NM26-2198, a first-in-class bi-specific antibody for the treatment of moderate-to-severe atopic dermatitis (AD).

The first subject dosing marks the beginning of a combined single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a/1b clinical study, conducted in collaboration with Numab’s Asia-regional partner Kaken Pharmaceutical. The study will enroll non-Asian and Japanese healthy volunteers in the SAD sub-study and moderate-to-severe AD patients in the MAD sub-study. The SAD sub-study is currently enrolling.

“It is an exciting milestone for Numab to initiate this study of NM26-2198, our first product candidate focused on the treatment of inflammatory conditions and our second multi-specific antibody therapeutic to advance to the clinic,” said David Urech, Ph.D., Founder and Chief Executive Officer of Numab Therapeutics. “Our team has leveraged our technology platforms to develop this novel, first-in-class bi-specific antibody therapeutic that is designed to deliver an earlier onset of efficacy and larger effect size than current standard of care in atopic dermatitis and other inflammatory conditions.”

AD is an inflammatory skin condition which is characterized by a vicious cycle of skin inflammation that causes itching and scratching, which 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.

NM26-2198 is a first-in-class bi-specific antibody designed to simultaneously block itch and inflammation, with the aim of improving quality of life relative to current standard of care treatment. NM26-2198 inhibits three key pathways involved in disease pathogenesis of AD. While standard of care blocks IL-4 and IL-13, NM26-2198 blocks IL-31 in addition, thereby specifically targeting the neuroinflammatory pathway that causes itch.

“Based on its unique mechanism of action, we believe that NM26-2198 has the potential to deliver faster and more pronounced relief from itch than the current standard of care AD treatment,” said Peter Lichtlen, M.D., Ph.D., Founder and Chief Medical Officer of Numab Therapeutics. “This effect would be notable for people suffering with AD, as we know itch is a major factor of disease burden that negatively impacts quality of life and sleep. Faster onset and deepened suppression of itch is also expected to result in a more pronounced effect on AD lesions.” Dr. Lichtlen continued, “We look forward to progressing this Phase 1a/1b clinical trial. It has been a great privilege to develop this novel molecule with our world-class network of leading clinical experts in the AD space and to be supported by our Japanese partner Kaken Pharmaceutical on this path.”

About NM26-2198

NM26-2198 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. We believe that adding IL-31 mediated blockade of neuroinflammation to the repression of Th2 driven inflammation by IL-4/IL-13 blockade could enable a faster onset of action and improved efficacy compared to the current standard of care in AD, together with convenient subcutaneous administration. Numab is developing this molecule together with its Japanese partner Kaken Pharmaceutical. While Kaken owns commercial rights to certain Asian territories including Japan, Numab owns the rights to the rest of the world, including Europe and the United States of America.

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 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/.

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