Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-INHBE for the Treatment of Obesity
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has filed for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-INHBE, an investigational RNA interference (RNAi) therapeutic for obesity treatment. The company plans to file for a second obesity candidate, ARO-ALK7, by the end of 2024. Both therapies target the pathway signaling fat storage in adipose tissue.
Preclinical studies suggest these treatments may reduce body and fat mass while preserving lean muscle mass. The planned study, AROINHBE-1001, will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in up to 78 adult volunteers with obesity. It includes monotherapy assessment and combination therapy with tirzepatide, an approved GLP-1/GIP receptor co-agonist for diabetes and weight management.
ARO-INHBE aims to reduce hepatic expression of the INHBE gene and its product, Activin E, potentially increasing lipolysis and reducing adipose dysfunction, visceral adiposity, and insulin resistance.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) ha richiesto l'autorizzazione regolatoria per avviare uno studio clinico di Fase 1/2a per ARO-INHBE, una terapia sperimentale di interferenza dell'RNA (RNAi) per il trattamento dell'obesità. L'azienda prevede di presentare un secondo candidato per l'obesità, ARO-ALK7, entro la fine del 2024. Entrambe le terapie mirano al percorso di segnalazione per lo stoccaggio dei grassi nel tessuto adiposo.
Studi preclinici suggeriscono che questi trattamenti possono ridurre la massa corporea e grassa mantenendo la massa muscolare magra. Lo studio pianificato, AROINHBE-1001, valuterà la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica in un massimo di 78 volontari adulti con obesità. Include la valutazione della monoterapia e della terapia combinata con tirzepatide, un co-agonista approvato dei recettori GLP-1/GIP per la gestione del diabete e del peso.
ARO-INHBE ha l'obiettivo di ridurre l'espressione epatica del gene INHBE e del suo prodotto, Activin E, aumentando potenzialmente la lipolisi e riducendo la disfunzione adiposa, l'adiposità viscerale e la resistenza all'insulina.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) ha presentado una solicitud de autorización regulatoria para iniciar un ensayo clínico de Fase 1/2a de ARO-INHBE, un tratamiento experimental de interferencia de ARN (RNAi) para la obesidad. La compañía planea presentar un segundo candidato para la obesidad, ARO-ALK7, para finales de 2024. Ambas terapias apuntan a la vía que señala el almacenamiento de grasa en el tejido adiposo.
Los estudios preclínicos sugieren que estos tratamientos pueden reducir la masa corporal y grasa mientras preservan la masa muscular magra. El estudio planificado, AROINHBE-1001, evaluará la seguridad, la tolerabilidad, la farmacocinética y la farmacodinámica en hasta 78 voluntarios adultos con obesidad. Incluye la evaluación de monoterapia y terapia combinada con tirzepatide, un co-agonista de receptores GLP-1/GIP aprobado para la gestión de la diabetes y del peso.
ARO-INHBE tiene como objetivo reducir la expresión hepática del gen INHBE y su producto, Activin E, lo que potencialmente aumenta la lipólisis y disminuye la disfunción adiposa, la adiposidad visceral y la resistencia a la insulina.
애로우헤드 제약(나스닥: ARWR)은 비만 치료를 위한 연구 중인 RNA 간섭(RNAi) 치료제인 ARO-INHBE의 1/2a 단계 임상 시험을 시작하기 위해 규제 승인을 신청했습니다. 이 회사는 2024년 말까지 두 번째 비만 후보인 ARO-ALK7를 신청할 계획입니다. 두 가지 치료제 모두 지방 조직에서 지방 저장을 신호하는 경로를 겨냥하고 있습니다.
전임상 연구에 따르면 이러한 치료는 체중과 지방량을 줄이는 동시에 근육량을 유지할 수 있습니다. 계획된 연구인 AROINHBE-1001은 비만 성인 자원봉사자 최대 78명에 대한 안전성, 내약성, 약동학 및 약리학적 작용을 평가할 예정입니다. 이 연구는 단독 요법 평가와 당뇨병 및 체중 관리를 위한 승인된 GLP-1/GIP 수용체 공동 작용제인 티르제파타이드와의 병용 요법을 포함합니다.
ARO-INHBE는 INHBE 유전자와 그 생성물인 Activin E의 간 내 표현을 줄이는 것을 목표로 하여, 지방 분해를 증가시키고 지방 기능 장애, 내장 지방 증가 및 인슐린 저항성을 줄이는 데 기여할 수 있습니다.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) a déposé une demande d'autorisation réglementaire pour lancer un essai clinique de Phase 1/2a de ARO-INHBE, un traitement expérimental d'interférence par ARN (RNAi) pour la gestion de l'obésité. La société prévoit de demander un deuxième candidat contre l'obésité, ARO-ALK7, d'ici la fin de 2024. Les deux thérapies ciblent le chemin de signalisation du stockage des graisses dans le tissu adipeux.
Les études précliniques suggèrent que ces traitements peuvent réduire la masse corporelle et graisseuse tout en préservant la masse musculaire maigre. L'étude prévue, AROINHBE-1001, évaluera la sécurité, la tolérabilité, la pharmacocinétique et la pharmacodynamique chez jusqu'à 78 adultes volontaires obèses. Elle inclut l'évaluation de la monothérapie et de la thérapie combinée avec le tirzepatide, un co-agoniste des récepteurs GLP-1/GIP approuvé pour la gestion du diabète et du poids.
ARO-INHBE vise à réduire l'expression hépatique du gène INHBE et de son produit, Activin E, ce qui peut potentiellement augmenter la lipolyse et réduire la dysfonction adipose, l'adiposité viscérale et la résistance à l'insuline.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) hat die behördliche Genehmigung beantragt, um eine klinische Phase 1/2a-Studie für ARO-INHBE, ein experimentelles RNA-Interferenz (RNAi)-Therapeutikum zur Behandlung von Adipositas, zu starten. Das Unternehmen plant, bis Ende 2024 einen zweiten Kandidaten für Adipositas, ARO-ALK7, einzureichen. Beide Therapien zielen auf den Signalweg ab, der die Fettspeicherung im Fettgewebe reguliert.
Präklinische Studien legen nahe, dass diese Behandlungen die Körper- und Fettmasse reduzieren und gleichzeitig die fettfreie Muskelmasse erhalten könnten. Die geplante Studie, AROINHBE-1001, wird Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik bei bis zu 78 erwachsenen Freiwilligen mit Adipositas bewerten. Sie umfasst die Bewertung der Monotherapie sowie der Kombinationstherapie mit Tirzepatid, einem zugelassenen GLP-1/GIP-Rezeptor-Co-Agonisten zur Behandlung von Diabetes und Gewichtskontrolle.
ARO-INHBE zielt darauf ab, die hepatische Expression des INHBE-Gens und seines Produkts, Activin E, zu reduzieren, wodurch potenziell die Lipolyse erhöht und die Fettfunktion, viszerale Adipositas und Insulinresistenz verringert werden.
- Filing for regulatory clearance to initiate Phase 1/2a clinical trial of ARO-INHBE for obesity treatment
- Plans to file for regulatory clearance for ARO-ALK7, a second obesity candidate, by end of 2024
- Preclinical studies show potential for reducing body and fat mass while preserving lean muscle mass
- Planned study to evaluate ARO-INHBE both as monotherapy and in combination with approved drug tirzepatide
- None.
- In preclinical studies ARO-INHBE reduced body weight and fat mass with a novel mechanism of action that may preserve lean muscle mass compared to currently approved obesity therapies
“Arrowhead’s two investigational RNAi therapies for the treatment of obesity, ARO-INHBE and ARO-ALK7, are both designed to intervene in the same pathway that signals the body to store fat in adipose tissue. We have generated very promising preclinical data that suggests inhibition of these targets reduces body mass and fat mass but spares lean muscle mass resulting in improved body composition,” said James Hamilton, M.D., Chief of Discovery and Translational Medicine at Arrowhead. “We have designed the initial Phase 1/2 study to evaluate single and multiple doses of ARO-INHBE monotherapy in Part 1 which will enroll patients with obesity, and to evaluate multiple doses of ARO-INHBE in combination with tirzepatide in Part 2 which will enroll diabetic and non-diabetic patients with obesity. We believe new therapeutic strategies with novel mechanisms of action, like ARO-INHBE and ARO-ALK7, have the potential to make a significant impact on the way obesity is treated and we are eager to initiate clinical studies of these important new programs.”
ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. INHBE is a promising genetically validated target in which loss-of-function INHBE variants in humans are associated with lower risk of obesity and metabolic diseases, such as type 2 diabetes. Activin E acts as a ligand in a pathway that regulates energy homeostasis in adipose tissue. Intervening in this pathway with investigational ARO-INHBE treatment has the potential to increase lipolysis, and reduce adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance.
An application for approval to initiate the clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority for review by the Standing Committee on Therapeutic Trials. Pending clearance, Arrowhead intends to proceed with AROINHBE-1001, A Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE in up to 78 adult volunteers with obesity. Part 1 of the study is designed to assess single and multiple doses of ARO-INHBE monotherapy, and Part 2 of the study is designed to assess ARO-INHBE in combination with tirzepatide, a subcutaneously administered GLP-1/GIP receptor co-agonist that has been approved in
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
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Source: Arrowhead Pharmaceuticals, Inc.
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Arrowhead Pharmaceuticals, Inc.
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Source: Arrowhead Pharmaceuticals, Inc.
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