HSO-001 synergistically lowered antibody levels, a measure of efficacy against hay fever. Based on these results, HSO-001 is expected to produce faster and longer-lasting effects.
HSO-001, co-developed with and in-licensed from Daiichi Sankyo, is a novel and potent agonist for toll-like receptor 4 (TLR4), which plays crucial roles in the recognition of allergens and induction of immune responses, that is designed to be used in combination with an existing SLIT such as house dust mite (HDM), cedar pollen and other tree and grass pollen. HSO-001 in combination with allergen rapidly induced up to seven times more serum antigen-specific IgG and IgA, biomarkers of efficacy, than allergen alone in a mouse SLIT model. This synergistic effect was seen with different allergens, suggesting broader application for combination therapy with existing SLITs. As we have also obtained data suggesting an increased uptake of antigen by immune cells in sublingual tissues by HSO-001, the involvement of Treg and suppression of histamine release in mast cells, we believe that in clinical practice, SLIT therapy is expected to enhance the therapeutic effect and shorten the treatment period by increasing IgG4 and IgA and Treg production, and so on. In addition, we are investigating its use on atopic dermatitis and asthma, as SLIT has been documented to be effective in reducing the severity of these allergic diseases. We plan to conduct a Phase 1 study in 2024 to establish safety and early POC.