Aclaris Therapeutics Secures U.S. Food and Drug Administration IND Clearance for ATI-052, Enabling Advancement of its Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody
Aclaris Therapeutics (NASDAQ: ACRS) has received FDA clearance for its Investigational New Drug (IND) application to conduct a Phase 1a/1b clinical trial of ATI-052, a bispecific anti-TSLP/IL-4R monoclonal antibody. The trial, expected to begin in Q2 2025, will evaluate single and multiple ascending doses followed by a proof-of-concept portion in an undisclosed indication.
ATI-052, acquired through a license agreement with Biosion, is designed to exhibit high binding affinity and dual blockade of both the TSLP ligand and IL-4 receptor, inhibiting key proinflammatory pathways. This bispecific antibody technology represents a potential advancement in immunotherapy, as these engineered antibodies can bind to two targets simultaneously, potentially offering enhanced efficacy over traditional monoclonal antibodies.
Aclaris Therapeutics (NASDAQ: ACRS) ha ottenuto l'autorizzazione dalla FDA per la sua domanda di Investigational New Drug (IND) per condurre uno studio clinico di Fase 1a/1b su ATI-052, un anticorpo monoclonale bispecifico anti-TSLP/IL-4R. Lo studio, previsto per iniziare nel secondo trimestre del 2025, valuterà dosi singole e multiple crescenti, seguite da una fase di proof-of-concept in un'indicazione non divulgata.
ATI-052, acquisito tramite un accordo di licenza con Biosion, è progettato per mostrare un'elevata affinità di legame e un doppio blocco sia del ligando TSLP che del recettore IL-4, inibendo le principali vie proinfiammatorie. Questa tecnologia di anticorpi bispecifici rappresenta un potenziale progresso nell'immunoterapia, in quanto questi anticorpi ingegnerizzati possono legarsi simultaneamente a due bersagli, offrendo potenzialmente una maggiore efficacia rispetto agli anticorpi monoclonali tradizionali.
Aclaris Therapeutics (NASDAQ: ACRS) ha recibido la aprobación de la FDA para su solicitud de Investigational New Drug (IND) para llevar a cabo un ensayo clínico de Fase 1a/1b de ATI-052, un anticuerpo monoclonal bispecífico anti-TSLP/IL-4R. El ensayo, que se espera comience en el segundo trimestre de 2025, evaluará dosis ascendentes únicas y múltiples, seguido de una fase de prueba de concepto en una indicación no revelada.
ATI-052, adquirido mediante un acuerdo de licencia con Biosion, está diseñado para mostrar una alta afinidad de unión y bloqueo dual tanto del ligando TSLP como del receptor IL-4, inhibiendo vías proinflamatorias clave. Esta tecnología de anticuerpos bispecíficos representa un posible avance en inmunoterapia, ya que estos anticuerpos diseñados pueden unirse simultáneamente a dos objetivos, ofreciendo potencialmente una mayor eficacia que los anticuerpos monoclonales tradicionales.
Aclaris Therapeutics (NASDAQ: ACRS)는 ATI-052라는 이중특이성 항-TSLP/IL-4R 단클론항체에 대한 임상시험계획(IND)을 FDA로부터 승인받았습니다. 이 1a/1b상 임상시험은 2025년 2분기에 시작될 예정이며, 단회 및 다회 점증 투여를 평가한 후 비공개 적응증에서 개념 증명 단계를 진행할 예정입니다.
Biosion과의 라이선스 계약을 통해 획득한 ATI-052는 TSLP 리간드와 IL-4 수용체를 동시에 강력히 결합 및 차단하여 주요 염증 경로를 억제하도록 설계되었습니다. 이 이중특이성 항체 기술은 두 개의 표적에 동시에 결합할 수 있어 기존 단클론항체보다 향상된 효능을 제공할 가능성이 있는 면역치료 분야의 진보를 의미합니다.
Aclaris Therapeutics (NASDAQ : ACRS) a obtenu l'autorisation de la FDA pour sa demande d'Investigational New Drug (IND) afin de mener un essai clinique de Phase 1a/1b sur ATI-052, un anticorps monoclonal bispécifique anti-TSLP/IL-4R. L'essai, prévu pour débuter au deuxième trimestre 2025, évaluera des doses uniques et multiples ascendantes, suivies d'une phase de preuve de concept dans une indication non divulguée.
ATI-052, acquis via un accord de licence avec Biosion, est conçu pour présenter une forte affinité de liaison et un double blocage à la fois du ligand TSLP et du récepteur IL-4, inhibant ainsi des voies pro-inflammatoires clés. Cette technologie d'anticorps bispécifiques représente une avancée potentielle en immunothérapie, car ces anticorps ingénierés peuvent se lier simultanément à deux cibles, offrant potentiellement une efficacité supérieure aux anticorps monoclonaux traditionnels.
Aclaris Therapeutics (NASDAQ: ACRS) hat von der FDA die Genehmigung für seinen Antrag auf ein Investigational New Drug (IND) erhalten, um eine Phase 1a/1b klinische Studie mit ATI-052, einem bispezifischen Anti-TSLP/IL-4R monoklonalen Antikörper, durchzuführen. Die Studie, die voraussichtlich im zweiten Quartal 2025 beginnt, wird Einzel- und mehrfach ansteigende Dosen evaluieren, gefolgt von einem Proof-of-Concept-Abschnitt bei einer nicht offengelegten Indikation.
ATI-052, erworben durch eine Lizenzvereinbarung mit Biosion, ist darauf ausgelegt, eine hohe Bindungsaffinität und eine doppelte Blockade sowohl des TSLP-Liganden als auch des IL-4-Rezeptors zu zeigen und dadurch wichtige proinflammatorische Signalwege zu hemmen. Diese bispezifische Antikörpertechnologie stellt einen potenziellen Fortschritt in der Immuntherapie dar, da diese konstruierten Antikörper gleichzeitig an zwei Ziele binden können und somit möglicherweise eine verbesserte Wirksamkeit gegenüber herkömmlichen monoklonalen Antikörpern bieten.
- FDA clearance received for ATI-052 IND application, enabling clinical trials
- Potential best-in-class bispecific antibody with dual blocking mechanism
- Strategic licensing agreement with Biosion securing rights to ATI-052
- Clinical trial results not expected until after Q2 2025
- Target indication for proof-of-concept study remains undisclosed
Insights
FDA clearance of Aclaris' IND for bispecific antibody ATI-052 enables clinical trials; represents significant regulatory milestone for company's immuno-inflammatory pipeline.
The FDA clearance of Aclaris' IND application for ATI-052 represents a critical regulatory milestone that formally allows the company to begin human clinical testing of this novel bispecific antibody. This clearance effectively removes a major regulatory hurdle in the drug development pathway.
The technology behind ATI-052 is particularly noteworthy. As a bispecific antibody targeting both TSLP ligand and IL-4 receptor, it employs an advanced approach to simultaneously block two distinct inflammatory mediators. This dual-targeting mechanism has scientific merit in potentially offering enhanced efficacy compared to single-target approaches in treating immuno-inflammatory conditions.
The planned Phase 1a/1b trial structure follows standard early-stage biological drug development methodology, with single and multiple ascending dose components to establish safety and dosing parameters, followed by an initial proof-of-concept evaluation. While the specific indication remains undisclosed, the mechanism suggests potential applications across various immuno-inflammatory disorders.
For context, IND clearance is an early milestone in a lengthy development process. Phase 1 trials primarily assess safety rather than efficacy, and the majority of drugs that enter clinical testing don't ultimately receive approval. Nevertheless, this progression demonstrates the company's ability to advance novel biologics through regulatory requirements and into the clinic.
IND clearance for ATI-052 demonstrates pipeline progress for small-cap Aclaris; advancement to clinical stage derisks development pathway despite early stage.
For a company with
This milestone is significant for Aclaris as it demonstrates continued execution in advancing its immuno-inflammatory pipeline. Notably, the company highlighted that ATI-052 was obtained through a license agreement with Biosion, indicating strategic external innovation to complement internal R&D efforts.
The planned initiation of the Phase 1a/1b trial in Q2 2025 provides investors with a concrete timeline for this upcoming catalyst. Early clinical data from this program will likely emerge in late 2025 or 2026, depending on enrollment rates and study design.
While biologic drug development carries substantial risk and typically requires significant capital investment through the clinical phases, innovative bispecific antibodies targeting established inflammatory pathways have generated considerable interest from larger pharmaceutical companies. The dual blockade approach targeting TSLP and IL-4R pathways could potentially differentiate this asset if early clinical data demonstrates advantages over single-target therapies.
For Aclaris, successfully advancing ATI-052 through early clinical development could enhance its strategic position, though substantial development work and capital requirements lie ahead before potential commercialization.
- Initiation of Upcoming Phase 1a/1b Clinical Trial Expected in the Second Quarter of 2025 -
WAYNE, Pa, April 22, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody.
“Therapeutic innovation is at the core of the important work we do at Aclaris, and bispecific antibodies represent a groundbreaking innovation in immunotherapy that we believe will evolve the therapeutic armamentarium in a variety of settings,” said Dr. Hugh Davis, Aclaris’ President and Chief Operating Officer. “Key to our license agreement with Biosion, Inc. were the rights to ATI-052, a potential best-in-class investigational bispecific antibody that exhibits a high binding affinity to, and dual blockade of, both the TSLP ligand and the IL-4 receptor, and as such inhibits a key central proinflammatory pathway. Developing bispecific antibodies for immuno-inflammatory disorders is of significant interest to Aclaris, and the clearance of the ATI-052 IND by the FDA is an important milestone in that regard.”
The randomized, blinded, placebo-controlled, Phase 1a/1b clinical trial will evaluate single and multiple ascending doses of ATI-052 followed by a proof-of-concept portion in an undisclosed indication. The Company expects to initiate the trial in the second quarter of 2025.
Bispecific antibodies are engineered to have two distinct binding domains that can bind to two targets simultaneously. This dual binding and pathway inhibition potentially enhances efficacy over traditional monoclonal antibodies, with broad applications for the potential treatment of many immune-modulated diseases.
About Investigational New Drug Applications (INDs)
An IND application is a request submitted to the FDA seeking permission to test a new drug in humans. The application includes detailed information about the investigational drug, its composition, pharmacology and toxicology data from preclinical studies, proposed clinical trial protocols, and information on manufacturing and quality control. Organizations can initiate a clinical trial in the U.S. only with IND clearance from the FDA.
About ATI-052
ATI-052 is an investigational, potential best-in-class anti-TSLP/IL-4R bispecific monoclonal antibody being developed to treat certain immuno-inflammatory diseases. ATI-052 targets thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4R) that blocks both the upstream TSLP receptor signal transduction and downstream IL-4R activation which inhibits both IL-4 and IL-13 signaling, thereby inhibiting this central proinflammatory pathway and potentially offering enhanced efficacy through dual pathway inhibition. ATI-052 utilizes the same TSLP antigen-binding fragment (Fab) region as bosakitug (ATI-045), Aclaris’ investigational anti-TSLP monoclonal antibody, but is engineered to bind more tightly to the neonatal Fc receptor (FcRn), potentially extending its half-life. ATI-052 has the potential to treat a variety of atopic, immunologic and respiratory diseases. Aclaris has the exclusive worldwide rights to ATI-052, excluding Greater China.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding its development plans for ATI-052, including the anticipated design and timing for its Phase 1a/1b trial of ATI-052, the potential for ATI-052 to be a best-in-class anti-TSLP/IL-4R bispecific monoclonal antibody and the therapeutic potential of ATI-052. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2024, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Aclaris Therapeutics Contact:
Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com
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