Aankondiging • Apr 30

Aclaris Therapeutics Announces Positive Full Top Line First-In-Human Results from Phase 1A Healthy Volunteer Clinical Trial of ATI-052 and Lichen Planus as Lead Indication for ATI-2138

Aclaris Therapeutics, Inc. provided a clinical update on its biologic and oral inhibitor compounds including positive full top line results from the first-in-human Phase 1a single (SAD) and multiple ascending dose (MAD) trial of its anti-TSLP/IL-4Ra bispecific antibody ATI-052 and the selection of lichen planus (LP) as the lead indication for its selective ITK/JAK3 inhibitor ATI-2138. Positive full results from Phase 1a trial of anti-TSLP/IL-4Ra bispecific antibody ATI-052 exceed Aclaris’ target profile, validating potential best-in-class potency advantage and opportunity for extended dosing. Estimated half-life of approximately 45 days; unlocks opportunity for up to three-month dosing interval. Complete and sustained inhibition of TSLP-induced and IL-4 induced CCL17 (TARC) provides potential to raise efficacy ceiling in Th2-driven diseases. Enrollment and dosing ongoing in Phase 1b trials in asthma and atopic dermatitis (AD) with top line results expected in the second half of 2026. Lichen planus selected as lead indication for ATI-2138; potential to be first mechanistically complete therapeutic candidate designed to address root inflammation and symptoms. ATI-052 is an investigational anti-TSLP and anti-IL-4Ra bispecific antibody that exhibits high binding affinity to, and dual blockade of, both the TSLP receptor signal transduction and downstream IL-4Ra activation thereby inhibiting this central proinflammatory pathway. By addressing the shared receptor IL-4Ra, ATI-052 blocks IL-4 and IL-13 biological activity, key cytokines driving Th2 inflammation. ATI-052 exhibited a potential best-in-class pharmacokinetic (PK) profile, including an estimated half-life of approximately 45 days. Dose proportional PK was observed across the pharmacologic dose range, including dose proportional increases in Cmax (maximum peak concentration) and AUC (area under the curve; a measure representing total systemic exposure). Pharmacodynamic (PD) results validate the potency of ATI-052, including robust target engagement and near complete target occupancy. ATI-052 demonstrated complete and sustained inhibition through at least week 20 (four months post last dose) of ex vivo TSLP stimulated CCL17/TARC and at least week 12 (two months post last dose) of ex vivo IL-4 stimulated CCL17/TARC in the 480 mg MAD cohort. The combination of the strong and sustained PK duration and PD effect supports the potential for up to every three-month dosing. No impact of anti-drug antibodies (ADA) on PK or PD has been observed in this trial. ATI-052 was well tolerated and demonstrated a favorable safety profile across all SAD and MAD cohorts, consistent with the interim results; no safety signals including conjunctivitis were observed. The randomized, blinded, placebo-controlled Phase 1a portion of the first-in-human study was designed to evaluate the safety, tolerability, PK, and PD of subcutaneously administered ATI-052 in healthy adults receiving SAD and MAD doses. In the SAD portion, four cohorts of 8 healthy volunteers each were randomized 3:1 to receive a single dose of ATI-052 (30, 120, 360, or 720 mg) or placebo. In the MAD portion, two cohorts of 8 healthy volunteers each were randomized 3:1 to receive five doses of two dose levels of ATI-052 (240 or 480 mg) or placebo administered every 7 days. Participants were followed for safety for approximately 16 weeks for the SAD cohorts and 20 weeks for the MAD cohorts. In January 2026, Aclaris announced the initiation of a Phase 1b proof-of-concept (POC) trial in patients with atopic dermatitis (EASI >21). In February 2026, the Company initiated a Phase 1b POC trial in patients with asthma on GINA (Global Initiative for Asthma) steps 2-4 treatment prior to screening. Enrollment is ongoing in both trials, and top line results from both are expected in the second half of 2026. Given the results observed to date and its mechanism of action targeting TSLP as well as effects of IL-4 and IL-13 through blockade of the shared receptor IL-4Ra, the Company announced its intent to initiate a Phase 2b program with ATI-052, initially targeting asthma, in the fourth quarter of 2026. ATI-2138 is a highly potent and selective novel investigational pharmacologic agent that acts as a dual inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3); the dual mechanism enables deep suppression of pathogenic T-cells via inhibition of TCR signaling and effector cytokine activation. Aclaris intends to initiate a phased multi-part Phase 2b basket study of ATI-2138 in lichen planus (LP), an unaddressed chronic, inflammatory, CD8+/Th1-driven interface dermatitis impacting approximately 0.1% to 1.0% of the population. The trial is expected to comprise the three most common LP subtypes: erosive mucosal, cutaneous, and lichen planopilaris (LPP), a rare form of LP that causes permanent hair loss. The most common symptoms of LP include sores, pain, difficulty eating, severe itch, scales/plaques, hair loss, and fatigue; quality of life is also affected in most patients, including due to anxiety and depression. There is also the potential for malignancy in certain subtypes. Disease management has focused on immunosuppression and symptom control; there are currently no FDA-approved therapies. Despite the lack of therapeutic options, approximately 40% of patients seek treatment. An oral agent like ATI-2138 has the potential to provide rapid symptom and itch relief and address multi-site (cutaneous, oral, and scalp) disease involvement. The Company estimates that the potential market opportunity in the U.S. for an oral therapeutic for LP exceeds $1.0 billion with opportunity up to $4.0 billion. Aclaris expects to initiate Part A (erosive mucosal; cutaneous) of this trial in the second half of 2026 and intends to move into Part B (LPP) soon thereafter. ATI-052 is an investigational humanized anti-TSLP and anti-IL-4Ra bispecific antibody that exhibits high binding affinity to and dual blockade of both the upstream thymic stromal lymphopoietin (TSLP) receptor signal transduction and downstream interleukin-4 receptor (IL-4R) activation thereby inhibiting this central proinflammatory pathway. ATI-052 targets TSLP, which sits at the top of the inflammatory cascade; by targeting IL-4Ra, it blocks both downstream IL-4 and IL-13, which are key cytokines involved in Th2-mediated inflammation and allergic diseases. ATI-052 exhibits potential best-in-class potency and utilizes the same TSLP antigen-binding fragment (Fab) region as bosakitug (ATI-045), retaining the dissociation kinetics, long residence time, and high potency advantages over comparator antibodies, but is engineered to bind more tightly to the neonatal Fc receptor (FcRn), potentially extending its half-life.

Aankondiging • Jan 10

Aclaris Therapeutics, Inc. Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis

Aclaris Therapeutics, Inc. announced top-line results from its Phase 2b study of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (AD) (ATI-1777-AD-202; NCT05432596). ATI-1777 was generated from Aclaris’ proprietary KINect® drug discovery platform. ATI-1777-AD-202 was a Phase 2b, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple concentrations (0.5%, 1% and 2%) of twice daily treatment with ATI-1777 and a single concentration (2%) of once daily treatment with ATI-1777. For this trial, ATI-1777 was developed as an emollient-containing spray formulation. The trial randomized 250 patients with mild, moderate or severe AD, including adults and children as young as 12 years old, across 30 clinical trial sites in the United States. Results: The trial met the primary efficacy endpoint, the percent change from baseline in the Eczema Area and Severity Index (EASI) score at week 4, with statistical significance for patients treated with ATI-1777 2% BID compared to patients treated with vehicle (69.7% versus 58.7% in the pooled vehicle group, p=0.035). In addition, the following results were observed with respect to the primary endpoint: While not statistically superior, ATI-1777 2% QD showed a trend toward significance (68.3% compared to 59.5% in vehicle, p=0.086); In the per-protocol population, or all patients who had week 4 data with no major protocol deviations, ATI-1777 2% BID demonstrated a 70.8% reduction in EASI compared to a 58.5% reduction in vehicle (p=0.025), and ATI-1777 2% QD demonstrated a 68.4% reduction in EASI compared to a 59.7% reduction in vehicle (p=0.102); In addition, a post-hoc analysis of only patients who had baseline severity of moderate or severe AD showed a 65.6% and 65.1% reduction in the EASI score at week 4 in ATI-1777 2% BID and ATI-1777 2% QD, respectively, compared to a 52.6% reduction in the pooled vehicle group (p=0.029 and 0.040, respectively). While not statistically powered, ATI-1777 2% BID and 2% QD also showed improvement in the proportion of patients who reached an IGA-TS response (Investigator Global Assessment Treatment Success, the U.S. FDA regulatory endpoint) at week 4 (ATI-1777 2% BID: 37.2% compared to 27.1% in vehicle, p=0.141; ATI-1777 2% QD: 36.6% compared to 26.3% in vehicle, p=0.137). The per-protocol population demonstrated an IGA-TS response at week 4 of 41.8% for ATI-1777 2% BID compared to 25.5% in vehicle (p=0.059) and 39.8% for ATI-1777 2% QD compared to 25.4% in vehicle (p=0.079). A PK analysis showed minimal levels of exposure to ATI-1777. The mean steady state trough drug levels at week 4 were 0.319 ng/mL, representing 0.7% of IC for JAK 1/3 inhibition in whole blood. In total, 97% of ATI-1777 plasma samples from dosed patients had concentrations below 1/10th of the IC, and six samples (from five ATI-1777-treated patients) of 570 samples analyzed had concentrations above 1/4 of the IC. No meaningful safety findings were observed and ATI-1777 was well tolerated. In particular, no adverse events (AEs) commonly associated with JAK inhibitors, including serious infections, malignancies, major adverse cardiovascular events (MACE) and thromboses, were observed in patients treated with ATI-1777. The most common AEs in patients treated with ATI-1777 (reported in =2% patients) were nasopharyngitis (ATI-1777: 2%; vehicle: 2%) and application site itch (ATI-1777: 2.5%; vehicle: 0%). Among patients receiving ATI-1777, there were no discontinuations due to AEs and one serious but unrelated AE in a patient (ATI-1777 2% QD) who completed the study. All other AEs were mild to moderate in severity.

Totaal aandeelhoudersrendement	-9.1%
Toekomstig dividendrendement	n/a
Dividendgroei	n/a
Volgende betaaldatum dividend	n/a
Ex-dividenddatum	n/a
Dividend per aandeel	n/a
Uitbetalingsratio	n/a

Segment	Dividendrendement
Bedrijf (ACRS)	n/a
Markt onderkant 25% (US)	1.4%
Markt Top 25% (US)	4.2%
Gemiddelde industrie (Pharmaceuticals)	2.1%
Analist prognose (ACRS) (tot 3 jaar)	n/a

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/05/31 23:01
Aandelenkoers aan het einde van de dag	2026/05/29 00:00
Inkomsten	2026/03/31
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Prakhar Agrawal	Cantor Fitzgerald & Co.
Donald Ellis	Citizens JMP Securities, LLC
Adam Vogel	Craig-Hallum Capital Group LLC

Aclaris Therapeutics Dividenden en inkoop

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Belangrijke informatie

Recente updates van dividend en inkoop

Recent updates

Consensus revenue estimates increase by 14%

First quarter 2026 earnings released: US$0.15 loss per share (vs US$0.12 loss in 1Q 2025)

Price target increased by 11% to US$9.44

Aclaris Therapeutics Announces Positive Full Top Line First-In-Human Results from Phase 1A Healthy Volunteer Clinical Trial of ATI-052 and Lichen Planus as Lead Indication for ATI-2138

Aclaris Therapeutics, Inc., Annual General Meeting, Jun 04, 2026

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New minor risk - Shareholder dilution

Consensus revenue estimates fall by 37%

Full year 2025 earnings: EPS in line with expectations, revenues disappoint

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New major risk - Revenue and earnings growth

Co-Founder exercised options and sold US$65k worth of stock

There's Reason For Concern Over Aclaris Therapeutics, Inc.'s (NASDAQ:ACRS) Massive 25% Price Jump

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New major risk - Share price stability

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Chief Business Officer exercised options and sold US$120k worth of stock

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Chief Business Officer exercised options and sold US$101k worth of stock

Price target increased by 32% to US$10.00

Consensus EPS estimates fall by 10%

New major risk - Shareholder dilution

Co-Founder exercised options and sold US$153k worth of stock

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Consensus EPS estimates fall by 20%

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Consensus revenue estimates decrease by 17%, EPS upgraded

Analysts Are Betting On Aclaris Therapeutics, Inc. (NASDAQ:ACRS) With A Big Upgrade This Week

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Consensus revenue estimates increase by 67%

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Price target decreased by 14% to US$1.55

Aclaris Therapeutics, Inc.(NasdaqGS:ACRS) dropped from Russell 3000 Growth Index

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