A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

Multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical study designed to evaluate the efficacy and safety of eblasakimab in participants with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab.The study consists of a 16-week treatment period and an 8-week follow-up period up to Week 24. Eligible participants will be randomized into one of the 2 treatment arms.

Start Date21 Dec 2022

Sponsor / Collaborator

Aslan Pharmaceuticals Ltd.

NCT05158023

/ CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Phase 2b study designed to evaluate the efficacy and safety of ASLAN004 in adult patients with moderate-to-severe Atopic Dermatitis (AD) who are candidates for systemic therapy. This study will have 5 treatment arms (4 active and 1 placebo).

Start Date16 Mar 2022

Sponsor / Collaborator

Aslan Pharmaceuticals Ltd.

NCT04090229

/ CompletedPhase 1

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis

A Phase 1B, multi-center, double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) clinical study is designed to evaluate ASLAN004 versus placebo in patients who have moderate-severe AD. The treatment period duration will be 8 weeks with a 12-week follow-up period after the end of treatment.

Start Date09 Sep 2019

Sponsor / Collaborator

Aslan Pharmaceuticals Ltd.

100 Clinical Results associated with Eblasakimab

100 Translational Medicine associated with Eblasakimab

100 Patents (Medical) associated with Eblasakimab

Literatures (Medical) associated with Eblasakimab

01 Nov 2024·BIODRUGS

Eblasakimab, an Anti-IL‑13Rα1 Antibody, Reduces Atopy-Associated Serum Biomarkers in Moderate‑to‑Severe Atopic Dermatitis

Article

Author: Cevikbas, Ferda ; Veverka, Karen A ; Ward, Alison

INTRODUCTION:

Eblasakimab, a first-in-class monoclonal antibody with a unique mechanism to target the interleukin (IL)-13 receptor alpha 1 (IL-13Rα1), inhibits IL-4/IL-13 signaling in the pathophysiology of atopic dermatitis (AD). This study investigates the impact of eblasakimab on type 2 inflammatory biomarkers in patients with moderate-to-severe AD.

METHODS:

A double‑blind, multiple ascending dose, phase Ib study evaluated the effect of eblasakimab (200, 400, 600 mg) or placebo administered subcutaneously once weekly for 8 weeks in patients with moderate‑to‑severe AD. Serum levels of thymus and activation-regulated chemokine (TARC), total immunoglobulin E (IgE), and lactate dehydrogenase (LDH) were assessed.

RESULTS:

Eblasakimab suppressed TARC, IgE, and LDH in the 400-mg and 600-mg groups over 8 weeks of treatment. Patients in the 400-mg and 600-mg groups experienced a reduction of 72.8% (p = 0.004) and 62.9% (p = 0.003), respectively, for TARC, 35.1% (p = 0.006) and 20.9% (not significant; NS), respectively, for IgE, and 24.6% (NS) and 23.1% (NS), respectively, for LDH between baseline and Week 8. Reduction in serum TARC in the 400-mg group was significantly greater than placebo as early as Week 1, whereas reductions in total IgE were more gradual. Serum TARC and total IgE remained suppressed in the 400-mg and 600-mg eblasakimab groups for 4-6 weeks following the last administered dose.

CONCLUSION:

The effect of eblasakimab on circulating AD‑associated biomarker levels was accompanied by improvements in signs and symptoms of AD, consistent with the inhibition of IL-13 and IL-4 signaling via the type 2 receptor.

TRIAL REGISTRATION NUMBER:

NCT04090229.

01 Nov 2024·JOURNAL OF INTERNATIONAL MEDICAL RESEARCH

IL-13 inhibition in the treatment of atopic dermatitis – new and emerging biologic agents

Review

Author: Yilmaz, Orhan ; Torres, Tiago ; Bernardo, Diana ; Teixeira, Carlos

Atopic dermatitis (AD) is a common, chronic, and recurrent inflammatory skin condition that affects a considerable portion of the population, and is particularly prevalent among children. The development of AD is influenced by environmental and genetic factors, which cause epidermal barrier dysfunction, immune dysregulation, and dysbiosis. In immune dysregulation, there is excessive production of cytokines. Among the cytokines, interleukin (IL)-13 plays a major role in the pathogenesis of AD. Searching for new and more selective treatments for moderate-to-severe cases is important because of the considerable effect of AD on the quality of life. Tralokinumab and lebrikizumab are selective IL-13 inhibitors that have demonstrated safety and efficacy as treatment options for AD in phase III trials. Tralokinumab is approved for use in Europe and the USA, while lebrikizumab is approved only in Europe. Cendakimab, which is another IL-13 selective inhibitor, has shown promising results in phase II trials, providing safe and effective outcomes. Eblasakimab, which disrupts IL-13 and IL-4 signaling pathways, is currently in phase II trials following well-tolerated administration in phase I studies. This narrative review aims to outline the current state of knowledge regarding the effectiveness and safety of these four biologic agents targeting IL-13 signaling.

01 Mar 2024·Journal of the American Academy of Dermatology

Safety and efficacy of eblasakimab, an interleukin 13 receptor α1 monoclonal antibody, in adults with moderate-to-severe atopic dermatitis: A phase 1b, multiple-ascending dose study

Article

Author: Kaoukhov, Alexandre ; Thng, Steven T G ; Veverka, Karen A ; Silverberg, Jonathan I ; Menezes, Josemund ; Blauvelt, Andrew ; Armstrong, April W

BACKGROUND:

Eblasakimab, an interleukin (IL)-13 receptor α1 antagonist, blocks IL-4 and IL-13 signaling through the type 2 receptor.

OBJECTIVE:

The safety and efficacy of eblasakimab was evaluated in adults with moderate-to-severe atopic dermatitis (AD).

METHODS:

In this phase 1b randomized, double-blinded study, 52 patients with moderate-to-severe AD received weekly subcutaneous injections of eblasakimab 200, 400, or 600 mg, or placebo for 8 weeks. Primary outcome was the incidence of treatment-emergent adverse events. Secondary outcomes included percentage change in the Eczema Area and Severity Index from baseline; Eczema Area and Severity Index improvement of at least 50%, 75%, or 90% from baseline; and percentage change in the peak-pruritus numeric rating scale score from baseline.

RESULTS:

Treatment-emergent adverse events were reported in 47% placebo and 71% eblasakimab patients; most were considered mild or moderate and did not lead to study discontinuation. At week 8 eblasakimab 600 mg showed statistically significant improvement in mean percentage change in Eczema Area and Severity Index versus placebo (-65% vs -27%, P = .014). Other key secondary physician- and patient-reported end points were met.

LIMITATIONS:

Longer studies are required to confirm eblasakimab safety and efficacy in AD patients.

CONCLUSIONS:

Treatment of adults with moderate-to-severe AD with eblasakimab was well-tolerated and associated with significant clinical improvements versus placebo.

News (Medical) associated with Eblasakimab

17 Jul 2024

·www.fiercebiotech.com

Aslan’s dream of challenging Dupixent dies as cash-strapped biotech winds down

All positions at the biotech have been terminated “effective immediately.” Aslan Pharmaceuticals had bold ambitions to challenge Sanofi and Regeneron's immunology blockbuster Dupixent, but now the cash-strapped biotech has run out of road. The California and Singapore-based biotech, which had cash and equivalents of $18.4 million as of the end of March, said it had “conducted a thorough review of all strategic alternatives” before deciding it had no option but to file for voluntary liquidation. For the biotech’s staff, it means all positions have been terminated “effective immediately,” the company said. The appointed liquidators will be responsible for winding up Aslan’s affairs, as well as searching for options for the biotech’s two main assets: the IL-13-targeting eblasakimab and the dihydroorotate dehydrogenase inhibitor farudodstat. Despite some mixed data on doses last year, Aslan had maintained high hopes for eblasakimab to challenge Sanofi and Regeneron’s atopic dermatitis blockbuster Dupixent. As recently as May, the biotech was pointing to positive interim data from a small, 22-patient phase 2 study that it said “showed unprecedented efficacy data compared to prior atopic dermatitis studies with biologics.” Aslan also said at the time that it was on track for a full readout for this study by the end of 2024, with an interim readout from a mid-stage trial of farudodstat in alopecia areata expected in the second quarter. The company didn’t give an estimate on how long it expected its $18.4 million to last, but the operational burn rate of $7.4 million for the first three months of the year suggested more money was needed soon. Despite these plans, the writing appeared to be on the wall for Aslan on Monday, when the company announced that it wouldn’t appeal Nasdaq’s decision to delist the biotech. In the past year, Aslan’s stock has shed 95% of its value, dropping from $22 per share in July 2023 to a closing price on Tuesday of just $1.10.

Phase 2Clinical Trial FailureClinical ResultFinancial Statement

17 Jul 2024

·www.globenewswire.com

ASLAN Pharmaceuticals Announces it Has Filed for Voluntary Liquidation of Its Sole Operating Subsidiary and is Commencing Steps to Place Itself Into Voluntary Liquidation

Following a thorough review of all strategic alternatives, ASLAN Pharmaceuticals Pte Ltd, the sole operating subsidiary of ASLAN Pharmaceuticals, has filed for voluntary liquidation Quantuma (Singapore) Pte Limited International has been appointed as the official liquidator and will seek potential strategic alternatives for the Company’s development programs, eblasakimab and farudodstat SAN MATEO, Calif. and SINGAPORE, July 17, 2024 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (“ASLAN” or the “Company”), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that its Singapore-incorporated, sole operating subsidiary, ASLAN Pharmaceuticals Pte Ltd (“ASLAN SG”), has filed for voluntary liquidation. The decision follows a comprehensive review by the Board of the Company of ASLAN SG’s financial position and strategic alternatives. Effective immediately, all employees of ASLAN SG and fellow subsidiary ASLAN Pharmaceuticals (USA) Inc. have been terminated. By a resolution in writing passed by the directors of ASLAN SG on July 17, 2024, it was resolved that ASLAN SG cannot by reason of its liabilities continue its business, and Mr Luke Anthony Furler and Mr Tan Kim Han of Quantuma (Singapore) Pte Limited were appointed as joint and several provisional liquidators (“Provisional Liquidators”) of ASLAN SG. The Provisional Liquidators will be responsible for the orderly winding up of ASLAN SG’s affairs, including seeking potential strategic alternatives for its development programs and the Company’s primary assets, eblasakimab and farudodstat, settling outstanding obligations, and distributing any remaining proceeds, if any, to creditors and shareholders, including the Company, in accordance with Singaporean law. Following the resolution in writing of the directors of ASLAN SG, the Board of the Company also resolved by a resolution in writing that the Company cannot by reason of its liabilities continue its business and that the Company will apply for liquidation under Cayman law procedures. As previously disclosed on July 15, 2024, the Company has received a staff delisting determination from the Nasdaq Stock Market due to its failure to meet continued listing requirements, and determined not to request a hearing before the Nasdaq Hearings Panel. As such, the Company expects its American Depository Shares (“ADSs”) will be suspended from trading in due course with trading moved to the over-the-counter market. Forward looking statements This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of the Company. These forward-looking statements may include, but are not limited to, statements regarding the trading price of the Company’s ADSs. The Company’s estimates, projections and other forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s orderly winding up, business, strategy, operations, or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, the Company’s orderly winding up process, as well as unexpected safety or efficacy data observed during preclinical or clinical studies; risks that future clinical trial results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials; clinical site activation rates or clinical trial enrollment rates that are lower than expected; the impact of health epidemics or pandemics, or geopolitical conflicts on the Company’s operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom the Company conducts business; general market conditions; and changes in the competitive landscape. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s U.S. Securities and Exchange Commission filings and reports (Commission File No. 001-38475), including the Company’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 12, 2024. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Contact Luke Furler Quantuma International Phone: (SG) +65 9821 4124/ (HK) +852 8170 3838 Email: Luke.Furler@quantuma.com

Executive Change

17 Jul 2024

·firstwordpharma.com

Financial woes force ASLAN to close shop, ending hopes of Dupixent rivalry

ASLAN Pharmaceuticals announced Wednesday that it has filed for voluntary liquidation of its sole operating subsidiary. The decision comes just months after the company reported promising interim data for its lead asset eblasakimab, an inhibitor of IL-13Rα1 that was being developed as a potential challenger to Sanofi and Regeneron Pharmaceuticals' immunology blockbuster Dupixent (dupilumab).In a statement Wednesday, ASLAN said the move is the culmination of "a comprehensive review by the board…of [the company's] financial position and strategic alternatives." As a result, all employees of ASLAN and its ASLAN Pharmaceuticals subsidiary have been terminated, effective immediately. The was based in California and Singapore.More to follow.

Acquisition

100 Deals associated with Eblasakimab

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 2	US	Aslan Pharmaceuticals Ltd.	16 Mar 2022
Dermatitis, Atopic	Phase 2	AU	Aslan Pharmaceuticals Ltd.	16 Mar 2022
Dermatitis, Atopic	Phase 2	CA	Aslan Pharmaceuticals Ltd.	16 Mar 2022
Dermatitis, Atopic	Phase 2	DO	Aslan Pharmaceuticals Ltd.	16 Mar 2022
Dermatitis, Atopic	Phase 2	IN	Aslan Pharmaceuticals Ltd.	16 Mar 2022
Dermatitis, Atopic	Phase 2	NZ	Aslan Pharmaceuticals Ltd.	16 Mar 2022
Dermatitis, Atopic	Phase 2	PL	Aslan Pharmaceuticals Ltd.	16 Mar 2022
Dermatitis, Atopic	Phase 2	SG	Aslan Pharmaceuticals Ltd.	16 Mar 2022
Moderate Atopic Dermatitis	Phase 1	US	Aslan Pharmaceuticals Ltd.	09 Sep 2019
Moderate Atopic Dermatitis	Phase 1	AU	Aslan Pharmaceuticals Ltd.	09 Sep 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04090229 (NCT04090229, Pubmed \| BioDrugs)	Phase 1	Moderate Atopic Dermatitis thymus and activation-regulated chemokine (TARC) \| total immunoglobulin E (IgE) \| lactate dehydrogenase (LDH)	-	Eblasakimab 400 mg	gsioiddjpv(cjfxxtkgjp) = prwycrshdc ruxgyqdyad (pyiazqplsr ) View more	-	15 Oct 2024
				Eblasakimab 600 mg	gsioiddjpv(cjfxxtkgjp) = tdwavnakci ruxgyqdyad (pyiazqplsr, NS) View more
NCT05694884 (TREK-DX, Biospace) Manual	Phase 2	Dermatitis, Atopic	22	Eblasakimab	rybccvpkiy(ywzpqdesel) = gvztcwgncv crfqldcqyz (djjurxagsy ) View more	Positive	22 Apr 2024
				Eblasakimab (baseline EASI score of 18 or above)	rybccvpkiy(ywzpqdesel) = nljfvgpjmd crfqldcqyz (djjurxagsy ) View more
NCT05158023 (EADV 12023 \| EADV 22023) Manual	Phase 2	Dermatitis, Atopic	289	eblasakimab 400 mg Q4W	jctkmobpkl(mpzifuuyhc) = ncmmovcpfa adtjoponya (yjocjfxoeu ) Met	Positive	11 Oct 2023
				eblasakimab 600 mg Q4W	jctkmobpkl(mpzifuuyhc) = alvzqpvefd adtjoponya (yjocjfxoeu ) Met View more
NCT04090229 (WCD2023)	Phase 1	Dermatitis, Atopic	-	Eblasakimab 200mg	ikwnmnjrnt(tnezecbeck) = qqgrllaicl fufxjkuirp (axyjbcarry ) View more	Positive	03 Jul 2023
				Eblasakimab 400mg	ikwnmnjrnt(tnezecbeck) = qtjvspiwnu fufxjkuirp (axyjbcarry ) View more
NCT04090229 (EADV2022)	Phase 1	Moderate Atopic Dermatitis	-	Eblasakimab 600 mg	zcfmfevgev(xohemqieti) = iwjzjczrws ytauynndnl (sgwzeygexy )	-	07 Sep 2022

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