Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-INHBE for the Treatment of Obesity
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has initiated a Phase 1/2a clinical trial for ARO-INHBE, its RNAi therapeutic candidate for obesity treatment. The company has dosed the first subjects and recently filed for regulatory clearance of a second obesity candidate, ARO-ALK7. Both therapeutics target a pathway that signals fat storage in adipose tissue.
Preclinical studies of ARO-INHBE showed promising results in reducing body weight and fat mass, with a potential advantage of better lean muscle mass preservation compared to existing obesity treatments. The Phase 1/2 study will evaluate ARO-INHBE both as a monotherapy in part 1 and in combination with tirzepatide in part 2, targeting patients with obesity.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) ha avviato uno studio clinico di Fase 1/2a per ARO-INHBE, il suo candidato terapeutico RNAi per il trattamento dell'obesità. L'azienda ha somministrato la dose ai primi soggetti e ha recentemente presentato una richiesta di autorizzazione regolatoria per un secondo candidato per l'obesità, ARO-ALK7. Entrambi i terapeutici mirano a una via che segnala l'immagazzinamento di grasso nel tessuto adiposo.
Gli studi preclinici su ARO-INHBE hanno mostrato risultati promettenti nella riduzione del peso corporeo e della massa grassa, con un potenziale vantaggio nella preservazione della massa muscolare magra rispetto ai trattamenti esistenti per l'obesità. Lo studio di Fase 1/2 valuterà ARO-INHBE sia come monoterapia nella parte 1 che in combinazione con tirzepatide nella parte 2, mirando a pazienti con obesità.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) ha iniciado un ensayo clínico de Fase 1/2a para ARO-INHBE, su candidato terapéutico de RNAi para el tratamiento de la obesidad. La compañía ha dosificado a los primeros sujetos y recientemente presentó una solicitud de autorización regulatoria para un segundo candidato contra la obesidad, ARO-ALK7. Ambos terapéuticos apuntan a una vía que señala el almacenamiento de grasa en el tejido adiposo.
Los estudios preclínicos de ARO-INHBE mostraron resultados prometedores en la reducción del peso corporal y la masa grasa, con una ventaja potencial en la preservación de la masa muscular magra en comparación con los tratamientos existentes para la obesidad. El estudio de Fase 1/2 evaluará ARO-INHBE tanto como monoterapia en la parte 1 como en combinación con tirzepatida en la parte 2, enfocándose en pacientes con obesidad.
애로우헤드 제약 (NASDAQ: ARWR)은 비만 치료를 위한 RNAi 치료제 후보인 ARO-INHBE에 대해 1/2a상 임상 시험을 시작했습니다. 회사는 첫 번째 피험자에게 약물을 투여했으며, 최근 두 번째 비만 후보인 ARO-ALK7에 대한 규제 승인을 신청했습니다. 두 치료제 모두 지방 조직의 지방 저장을 신호하는 경로를 겨냥하고 있습니다.
ARO-INHBE에 대한 전임상 연구는 체중과 지방량 감소에 있어 유망한 결과를 보여주었으며, 기존 비만 치료에 비해 근육량을 더 잘 보존할 수 있는 잠재적인 이점이 있습니다. 1/2상 연구에서는 ARO-INHBE를 1부에서는 단독요법으로, 2부에서는 티르제파타이드와 병용하여 비만 환자를 대상으로 평가할 예정입니다.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) a lancé un essai clinique de Phase 1/2a pour ARO-INHBE, son candidat thérapeutique ARN interférent pour le traitement de l'obésité. L'entreprise a dosé les premiers sujets et a récemment déposé une demande d'autorisation réglementaire pour un second candidat contre l'obésité, ARO-ALK7. Les deux thérapies ciblent une voie qui signale le stockage des graisses dans les tissus adipeux.
Les études précliniques sur ARO-INHBE ont montré des résultats prometteurs dans la réduction du poids corporel et de la masse grasse, avec un avantage potentiel dans la préservation de la masse musculaire maigre par rapport aux traitements existants de l'obésité. L'étude de Phase 1/2 évaluera ARO-INHBE à la fois en monothérapie dans la partie 1 et en combinaison avec le tirzepatide dans la partie 2, ciblant les patients obèses.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) hat eine klinische Studie der Phase 1/2a für ARO-INHBE initiiert, seinen RNAi-Therapeutikankandidaten zur Behandlung von Fettleibigkeit. Das Unternehmen hat die ersten Probanden behandelt und kürzlich einen Antrag auf regulatorische Zulassung für einen zweiten Fettleibigkeitskandidaten, ARO-ALK7, gestellt. Beide Therapeutika zielen auf einen Weg ab, der die Fettspeicherung im Fettgewebe signalisiert.
Präklinische Studien zu ARO-INHBE zeigten vielversprechende Ergebnisse bei der Reduzierung des Körpergewichts und der Fettmasse, mit einem potenziellen Vorteil bei der besseren Erhaltung der fettfreien Muskelmasse im Vergleich zu bestehenden Fettleibigkeitstherapien. Die Phase 1/2-Studie wird ARO-INHBE sowohl als Monotherapie in Teil 1 als auch in Kombination mit Tirzepatid in Teil 2 untersuchen, wobei Patienten mit Fettleibigkeit im Fokus stehen.
- Initiation of Phase 1/2a clinical trial for ARO-INHBE obesity treatment
- Preclinical studies showed promising results in weight and fat mass reduction
- Potential competitive advantage with better lean muscle mass preservation
- Development of second obesity candidate (ARO-ALK7) advancing to clinical trials
- Strategic expansion in the lucrative cardiometabolic disease market
- Early-stage clinical development with uncertain outcomes
- Will face competition from established obesity treatments
Insights
The initiation of Phase 1/2a trials for ARO-INHBE represents a strategic entry into the highly lucrative obesity therapeutics market. The trial's design is particularly noteworthy, structured in two parts - evaluating ARO-INHBE both as a standalone treatment and in combination with tirzepatide, Eli Lilly's successful GLP-1/GIP receptor agonist.
The RNAi therapeutic's mechanism targeting fat storage signaling pathways, coupled with preclinical data suggesting muscle mass preservation, could differentiate it from current GLP-1 agonists like Wegovy and Ozempic. This potential advantage addresses a key limitation of existing treatments where patients often lose both fat and muscle mass.
The concurrent development of ARO-ALK7 creates a compelling dual-program approach in obesity, potentially allowing for multiple shots on goal in this
This development positions Arrowhead Pharmaceuticals to potentially capture market share in the rapidly expanding obesity therapeutics sector. The RNAi approach represents a novel mechanism of action that could complement or compete with current GLP-1 therapies. The market has shown remarkable appetite for new obesity treatments, as evidenced by the success of Novo Nordisk and Eli Lilly.
The strategic decision to study combination therapy with tirzepatide is particularly shrewd - it hedges against direct competition while exploring potential synergistic effects that could lead to superior outcomes. This approach could also make Arrowhead an attractive partnership or acquisition target for larger pharmaceutical companies looking to expand their obesity portfolios.
With a market cap of
- ARO-INHBE targets a known pathway that signals the body to store fat in adipose tissue
- In preclinical studies ARO-INHBE reduced body weight and fat mass with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies
“ARO-INHBE is an important program for Arrowhead that complements our strategic focus on developing and commercializing important RNAi-based therapies for cardiometabolic diseases. Further, our preclinical studies have yielded promising results for this novel mechanism to reduce body weight and potentially preserve lean muscle mass resulting in improved body composition,” said James Hamilton, M.D., Chief of Discovery and Translational Medicine at Arrowhead. “The Phase 1/2 study will evaluate ARO-INHBE as a monotherapy in part 1 and as a combination therapy with tirzepatide in part 2, with both parts enrolling patients with obesity.”
About ARO-INHBE
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 improved fat distribution and lower risk of metabolic diseases, such as type 2 diabetes. Activin E acts as a ligand in a pathway that regulates energy homeostasis in adipose tissue. Inhibiting this pathway with investigational ARO-INHBE treatment has the potential to increase lipolysis, and reduce adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance.
About the AROINHBE-1001 Phase 1/2 Study
AROINHBE-1001 (NCT06700538) is 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.
Vince Anzalone, CFA
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ir@arrowheadpharma.com
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Source: Arrowhead Pharmaceuticals, Inc.
FAQ
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