BOSTON — Ukko, Inc. has dosed the first participant in a Phase 1/2a clinical study evaluating UKK-0018, an investigational treatment for peanut allergy.
The Boston biotechnology company said the first-in-human trial is designed to assess the safety, tolerability and preliminary efficacy of UKK-0018 in people with peanut allergies. The study is expected to enroll 32 participants at clinical sites in Australia and New Zealand, with initial data expected by early 2027.
UKK-0018 is a computationally designed modified peanut protein delivered through an mRNA/lipid nanoparticle platform. The treatment is intended to reduce the risk of allergic reactions by promoting protective B cell and T cell immune responses, including the production of protective IgG antibodies and T cell activity that may inhibit allergen-specific allergic responses.
“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.”
Ukko said preclinical mouse studies showed in-vivo efficacy, a strong safety profile and a rapid onset of protective IgG antibodies, along with rapid T cell modulation. The company is now evaluating whether those findings translate to people with peanut allergies.
“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.”
Ukko is developing immunotherapies for allergic diseases using computational protein design and RNA/LNP delivery.
