Safety, tolerability, and preliminary efficacy data expected by early 2027
BOSTON–(BUSINESS WIRE)–#UKK0018–Ukko, Inc., a biotechnology company re-inventing immunotherapy for allergic diseases, today announced that the first participant has been successfully dosed in its Phase 1/2a clinical study evaluating safety, tolerability and potential efficacy of UKK-0018 in peanut allergic subjects.
“Current approaches to peanut allergy remain burdensome and largely rely on strict avoidance, highlighting the significant unmet need for safer and more precise therapies that address the underlying immunological cause of disease,” said Uri Lopatin, M.D., Chief Executive Officer of Ukko. “By combining computational protein design with RNA/LNP delivery, UKK-0018 is designed to protect against peanut-induced anaphylaxis by promoting protective B and T cell immune responses. If successful, UKK-0018 has the potential to benefit patients faster, more safely, and with fewer treatments as compared to current approaches.”
“Dosing our first patient in the study of UKK-0018 is a critical step in our mission to improve treatment options for patients suffering from food allergy,” said Grace Chen M.D., Ukko’s Chief Medical Officer. “We believe that UKK-0018 has the potential to be a best in class immunotherapeutic and to address the significant patient and provider challenges that prevent patients from seeking treatment for their peanut allergies. We are excited to see our pre-clinical safety and tolerability replicate in human subjects. In our non-clinical program, we also saw rapid and durable protective responses in anaphylaxis-prone animals. This clinical study will be highly informative as it will also allow us to assess the potential for similar protection in peanut allergic adults. We look forward to progressing our study and sharing initial patient data at a scientific meeting early next year.”
The Phase 1/2a clinical trial is a first-in-human study intended to assess the safety, tolerability, and preliminary efficacy of UKK-0018 in participants with peanut allergies across multiple doses and dosing intervals. The ongoing trial is expected to enroll 32 participants across clinical sites in Australia and New Zealand. Initial data is expected by early 2027.
About UKK-0018
UKK-0018 is a computationally designed modified peanut protein. The protein is encoded in an mRNA/Lipid-Nanoparticle (LNP) and expressed following intramuscular injection of the mRNA/LNP. UKK-0018 is intended to reduce patient risk by inducing protective B and T cell responses such as production of protective IgG antibodies from B cells and expansion of T cells with the potential to inhibit allergic responses in an allergen specific fashion. Pre-clinical mouse studies demonstrated in-vivo efficacy, a strong safety profile, and a rapid onset of protective IgG antibodies with simultaneous rapid T cell modulation. Ukko is currently assessing UKK-0018 in patients with peanut allergies in its’ Phase 1/2a trial.
About Ukko
Ukko is a biotechnology company dedicated to designing safe immunotherapies to rapidly treat allergies and other immune-mediated conditions. The Company’s proprietary technology platform utilizes computational protein design to engineer hypo-allergenic proteins that retain their cognate immunogenicity. These engineered proteins are designed to reduce or eliminate potentially dangerous allergic reactions, while inducing a protective immune response. Ukko’s lead program, UKK-0018, is designed to protect patients at risk of peanut anaphylaxis.
By rethinking how to prevent allergic reactions at the molecular level, the Company aims to provide a safer, more precise and more convenient alternative to the current standard of care, reducing treatment burden and addressing the significant unmet need of individuals at risk for life-threatening allergic reactions. Ukko’s platform can be applied to other major allergens, including milk, tree nuts, and aeroallergens. Ukko is headquartered in Boston, Massachusetts, and Rehovot, Israel. Lipid nanoparticle technology for UKK-0018 has been provided by Acuitas Therapeutics Inc. For more information, please visit www.ukko.us, email [email protected], or follow us on LinkedIn.
Contacts
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