Yuhan Corporation presented the results of the phase 1b part 1 clinical trial confirming the safety and efficacy of lesigercept (development code YH35324), which is being developed as an allergy treatment, in a poster session at the American Academy of Allergy, Asthma & Immunology (AAAAI) held in San Diego, U.S., on 2nd (local time).
AAAAI is a prestigious academic conference attended by thousands of experts in allergic diseases from around the world each year.
Lesigercept is a candidate drug of the anti-IgE class of Fc fusion proteins. When allergic, immunoglobulin E increases, and it works by lowering the level of free IgE in the blood to improve allergic symptoms. This was adopted by Yuhan Corporation from GI Innovation in July 2020, and both companies are currently conducting joint research and development.
This phase 1b clinical trial was conducted at 9 university hospitals in Korea's allergy departments. The study involved comparing 3 mg/kg and 6 mg/kg doses of lesigercept or a single subcutaneous injection of the comparator drug Omalizumab 300 mg over 8 weeks in patients with chronic spontaneous urticaria who are inadequately controlled with H1 antihistamines.
According to the company, the results of part 1 clinical trial confirmed the safety of lesigercept in patients with chronic spontaneous urticaria. It also demonstrated stronger and more sustained inhibition of free IgE in the blood compared to the comparator drug Omalizumab. Omalizumab is an allergic treatment drug from global pharmaceutical corporations Roche and Novartis, and is sold under the brand name Xolair.
Utilizing the UAS7 (Urticaria Activity Score over 7 days), a metric for evaluating chronic urticaria, the results showed that the proportion of patients with complete symptom improvement (UAS7 score of 0, complete control) was higher in the lesigercept 6 mg/kg group than in the Omalizumab group.
Kim Yeol-hong, president of Yuhan Corporation R&D, noted, "In this trial, lesigercept demonstrated actual clinical symptom improvement in patients with H1 antihistamine-resistant chronic spontaneous urticaria, which is the primary development goal indication." Kim added, "We are currently analyzing the final results of the phase 1b clinical trial assessing safety, pharmacokinetics, and pharmacodynamics with repeated dosing, and we are reviewing optimal strategies to enter the next development stage."
Yuhan Corporation holds the global rights to lesigercept outside of Japan. The rights that were held by GI Innovation for Japan have been transferred to Maruho, a leading company in the dermatology field in Japan, in October 2023.