Nugel, Shaperon's atopic dermatitis treatment, has been completed the initial safety monitoring review for the Phase 2 clinical trials in the USA.
[Whole News Article]
Shaperon Successfully Completes Safety Monitoring for Phase 2 Clinical Trial of Atopic Dermatitis Treatment 'NuGel' in the U.S.
'NuGel' demonstrates safety in the first cohort; dosage escalation and continuation of clinical trials planned
Global technology transfer of 'NuGel' expected to gain momentum following progress in U.S. Phase 2 trial
Shaperon, a biotech company developing innovative immunotherapy drugs, announced on the 3rd that it has successfully completed the initial safety monitoring review for the Phase 2 clinical trial of its atopic dermatitis treatment, 'NuGel,' in the United States.
The first cohort of this Phase 2 trial, which underwent the safety monitoring review, consisted of a low-dose 'NuGel' group and a placebo group. After completing the dosing for the first cohort, the safety monitoring review was conducted. Following this, the trial will proceed with a second cohort involving the placebo group and a 'NuGel' group with incrementally increased doses.
On May 28, the first cohort completed dosing, and the initial safety monitoring committee reviewed the recruitment status, adherence to the study protocol, and safety data. Based on this review, the committee recommended dose escalation and continuation of the trial for the next cohort.
After receiving approval for the global Phase 2 clinical trial plan (IND) from the U.S. FDA in September last year, Shaperon successfully registered the first patient in March this year and completed the first cohort registration in April. This Phase 2b trial aims to evaluate the improvement in Eczema Area and Severity Index (EASI) scores in 210 patients with mild to moderate atopic dermatitis of various ethnicities. The trial is conducted in a double-blind, placebo-controlled manner. The primary goals include confirming the therapeutic dose for American patients, understanding the dose-response relationship, assessing drug safety, and evaluating correlations with biomarkers.
'NuGel' is the world's first inflammasome-modulating drug for atopic dermatitis based on the action of 'GPCR19.' Unlike existing inflammasome inhibitors, which mainly suppress the activation phase, 'NuGel' inhibits both the initiation and amplification phases of the inflammasome. Unlike competitors' pharmacological targets, 'NuGel's' targets are mainly present in innate immune-related cells and the skin epithelium, which constitute the primary lesions of dermatitis. This mechanism reduces the risk of side effects such as carcinogenicity or opportunistic infections commonly associated with the simultaneous suppression of most T lymphocyte functions by competitor drugs.
Moreover, 'NuGel' has shown superior clinical efficacy in more than 70% of atopic dermatitis patients with positive biomarkers compared to competitors in the domestic Phase 2a trial by increasing the number of T lymphocytes that regulate inflammation in the skin.
The global atopic dermatitis treatment market, valued at 20 trillion KRW in 2021, is expected to grow to 38 trillion KRW by 2030. Current atopic dermatitis patients are treated with steroids and FDA-approved drugs, but new drug development is needed due to side effects and insufficient efficacy. 'NuGel,' a non-steroidal atopic dermatitis drug candidate under development by Shaperon, is known to have better efficacy and fewer side effects compared to existing steroids and competitor drugs.
Additionally, Shaperon established a U.S. subsidiary, Hudson Therapeutics, in April last year to accelerate the progress of 'NuGel's' clinical trials in the U.S. In November, Shaperon appointed Janice McCourt, RPh, MBA, CLP, who has extensive experience in technology transfer, as the CEO of Hudson Therapeutics, further driving the progress of 'NuGel's' technology transfer.
https://www.newspim.com/news/view/20240603000135