- ASLAN plans to start TREK-DX (TRials in EblasaKimab in Dupilumab eXperienced AD sufferers) within the fourth quarter of 2022 to consider the efficacy and security of eblasakimab as a substitute biologic in atopic dermatitis (AD) sufferers who’ve discontinued therapy with dupilumab
- TREK-DX will examine the potential use of eblasakimab in sufferers which have been handled with dupilumab, complementing the continued TREK-AD trial in biologic naïve sufferers
- Results from each research might place eblasakimab as the popular first-choice biologic for the therapy of moderate-to-severe AD
- TREK-DX program is a part of the Company’s present working plan and has no influence on previously-reported money runway
- Further dialogue of TREK-DX will happen in the course of the Company-hosted R&D Day on September 15, 2022
MENLO PARK, Calif. and SINGAPORE, Sept. 14, 2022 (GLOBE NEWSWIRE) — ASLAN Pharmaceuticals (“ASLAN”, Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical firm growing progressive remedies to rework the lives of sufferers, right this moment introduced that it plans to provoke a brand new scientific trial of eblasakimab for the therapy of moderate-to-severe atopic dermatitis (AD) in grownup sufferers who’ve beforehand been handled with dupilumab. Eblasakimab is a possible first-in-class monoclonal antibody concentrating on the IL-13 receptor that has the potential to ship a differentiated efficacy and security profile. ASLAN expects to enroll the primary affected person within the trial within the fourth quarter of 2022.
“In contrast to our Phase 2b trial in biologic naïve patients, TREK-DX will allow us to evaluate eblasakimab’s unique mechanism of action in a new patient population,” mentioned Dr Carl Firth, CEO, ASLAN Pharmaceuticals. “We believe that many patients previously treated with dupilumab can benefit from eblasakimab, and this data could support the use of eblasakimab in both the biologic naïve and experienced patient populations.”
The TREK-DX trial is predicted to enroll 75 sufferers in a randomized, double-blind, placebo-controlled, multicenter trial in North America to consider the efficacy and security of eblasakimab in sufferers with moderate-to-severe AD beforehand handled with dupilumab. The trial will enroll sufferers who’ve discontinued dupilumab therapy for any cause, together with insufficient management of AD, lack of entry or an adversarial occasion. The program is a part of the Company’s present working plan and has no influence on its previously-reported money runway.
The trial will include a 16-week therapy interval and a 12-week security follow-up interval. The main efficacy endpoint is share change in Eczema Area Severity Index (EASI) rating from baseline to week 16. Key secondary efficacy endpoints embody the proportion of sufferers reaching Investigator Global Assessment (IGA) rating of 0 (clear) or 1 (nearly clear), proportion of sufferers with a 75% or better discount in EASI (EASI-75), proportion of sufferers reaching EASI-50 and EASI-90, and modifications in peak pruritus.
“Dupilumab has played an important role in demonstrating the benefits of targeting the IL4/IL-13 signaling pathway in AD. However, some patients do not demonstrate an optimal or sustained response to dupilumab, or develop adverse events such as conjunctivitis, and thus seek an alternative treatment option that could offer an improved safety and efficacy profile,” mentioned Dr Alex Kaoukhov, CMO, ASLAN Pharmaceuticals. “As we have seen in other indications, such as psoriasis, targeting different molecular components of the same signaling pathway can lead to different clinical outcomes and we believe that eblasakimab’s unique approach to blocking the Type 2 receptor may offer an effective treatment for dupilumab-experienced patients.”
ASLAN can be conducting the TREK-AD trial, a worldwide randomized, double-blind, placebo-controlled, dose-ranging, Phase 2b scientific trial, to consider the efficacy and security of eblasakimab in grownup sufferers with moderate-to-severe AD who’re candidates for systemic remedy. Topline knowledge from this trial is predicted within the first half of 2023.
ASLAN’s administration is internet hosting a Research and Development (R&D) Day on Thursday, September 15, 2022, from 10:00am to 1:30pm ET on the St. Regis Hotel in New York. To attend the occasion in individual or nearly, please click on right here for registration. A replay of the occasion and presentation supplies might be accessible on the Investor Relations part of ASLAN Pharmaceutical’s web site at https://ir.aslanpharma.com/
About eblasakimab
Eblasakimab is a novel, potential first-in-class monoclonal antibody that targets the IL-13 receptor α1 subunit (IL13Rα1), one of many parts of the Type 2 receptor. By blocking the Type 2 receptor, eblasakimab prevents signaling by means of each interleukin 4 (IL-4) and interleukin 13 (IL-13) – the important thing drivers of irritation in AD. Its distinctive mechanism of motion has the potential to ship a differentiated security and efficacy profile in addition to an improved dosing routine. ASLAN is at the moment conducting the TREK-AD trial, a worldwide randomized, double-blind, placebo-controlled, dose-ranging, Phase 2b scientific trial, to consider the efficacy and security of eblasakimab in grownup sufferers with moderate-to-severe AD who’re candidates for systemic remedy. Topline knowledge is predicted within the first half of 2023. The TREK-DX trial evaluating the efficacy and security of eblasakimab in grownup sufferers with moderate-to-severe AD who’ve beforehand been handled with dupilumab is predicted to enroll the primary affected person within the fourth quarter of 2022.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused biopharmaceutical firm growing progressive remedies to rework the lives of sufferers. ASLAN is at the moment evaluating eblasakimab, a potential first-in-class antibody concentrating on the IL-13 receptor, in atopic dermatitis, and farudodstat (also called ASLAN003), a potent oral inhibitor of the enzyme DHODH, in autoimmune illness. ASLAN has a group in California and in Singapore. For extra info please go to www.aslanpharma.com or comply with ASLAN on LinkedIn.
Forward trying statements
This launch incorporates forward-looking statements. These statements are primarily based on the present beliefs and expectations of the administration of ASLAN Pharmaceuticals Limited and/or its associates (the “Company”). These forward-looking statements might embody, however are usually not restricted to, statements concerning the Company’s business technique and scientific improvement plans; the Company’s plans to develop and commercialize eblasakimab and farudodstat; the security and efficacy of eblasakimab and farudodstat; the Company’s plans and anticipated timing with respect to scientific trials, scientific trial enrolment and scientific trial outcomes for eblasakimab and farudodstat; the potential of eblasakimab as a first-in-class therapy for atopic dermatitis and of farudodstat as a therapy for autoimmune illness; and the Company’s money runway. The Company’s estimates, projections and different forward-looking statements are primarily based on administration’s present assumptions and expectations of future occasions and developments, which have an effect on or might have an effect on the Company’s business, technique, operations, or monetary efficiency, and inherently contain important recognized and unknown dangers and uncertainties. Actual outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements on account of many dangers and uncertainties, which embody, surprising security or efficacy knowledge noticed throughout preclinical or scientific research; scientific web site activation charges or scientific trial enrolment charges which are decrease than anticipated; the influence of the COVID-19 pandemic or the continued battle between Ukraine and Russia on the Company’s business and the worldwide economy; common market situations; modifications within the aggressive panorama; and the Company’s skill to get hold of adequate financing to fund its strategic and scientific improvement plans. Other components that will trigger precise outcomes to differ from these expressed or implied in such forward-looking statements are described within the Company’s US Securities and Exchange Commission filings and studies (Commission File No. 001- 38475), together with the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on March 25, 2022. All statements aside from statements of historic reality are forward-looking statements. The phrases “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the unfavorable of these phrases, and related expressions that convey uncertainty of future occasions or outcomes are meant to establish estimates, projections, and different forward-looking statements. Estimates, projections, and different forward-looking statements converse solely as of the date they had been made, and, besides to the extent required by legislation, the Company undertakes no obligation to replace or evaluation any estimate, projection, or forward-looking assertion.
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