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Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1 Study of ARO-ANG3
Oct 15, 2018 at 7:30 AM EDT
— Arrowhead to host R&D Day October 16, 2018 to discuss ARO-ANG3 and its emerging pipeline of RNAi therapeutics PASADENA, Calif. --(BUSINESS WIRE)--Oct. 15, 2018-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for approval to begin a Phase 1 clinical
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— Arrowhead to host R&D Day October 16, 2018 to discuss ARO-ANG3 and its emerging pipeline of RNAi therapeutics
PASADENA, Calif.--(BUSINESS WIRE)--Oct. 15, 2018-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for approval to begin a Phase 1 clinical trial of ARO-ANG3, an RNAi-based investigational medicine targeting angiopoietin like protein 3 (ANGPTL3) being developed for the treatment of dyslipidemias and metabolic diseases. ARO-ANG3 will be the fourth therapeutic candidate to enter clinical studies that leverages Arrowhead’s Targeted RNAi Molecule (TRiM™) platform.
Chris Anzalone, Ph.D., president and CEO of Arrowhead Pharmaceuticals, said: “The ARO-ANG3 program has moved rapidly through preclinical development and we are thrilled to now submit the regulatory filing ahead of schedule. After positive initial signs of tolerability and activity with ARO-AAT and ARO-HBV, our first two clinical programs leveraging the TRiM™ platform, we are moving into the ARO-ANG3 clinical program with confidence.”
Pending approval, Arrowhead intends to proceed with AROANG1001, a Phase 1 single and multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of ARO-ANG3 in adult healthy volunteers and dyslipidemic patients. The study is designed to enroll up to 70 subjects.
An application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration.
As a reminder, Arrowhead will host a Research & Development (R&D) Day to discuss ARO-ANG3 and its emerging pipeline of RNAi therapeutics that leverage the Company’s proprietary Targeted RNAi Molecule (TRIM™) platform on October 16, 2018 in New York City.
The R&D Day will feature presentations by Ira Goldberg, M.D. (NYU Langone Medical Center), who will discuss the current treatment landscape and unmet medical need for patients with dyslipidemia and hypertriglyceridemia.
Arrowhead’s management team will provide an overview of the company’s pipeline of RNAi-based therapeutics. Discussion topics will include:
ARO-APOC3 for patients with hypertriglyceridemia. A CTA filing is planned by the end of 2018
ARO-ANG3 for patients with dyslipidemia
ARO-ENaC for patients with cystic fibrosis. A CTA filing is planned in 2019
ARO-HIF2 for patients with renal cell carcinoma. A CTA filing is planned in 2019
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. To reserve a seat, please click here to register.
A live and archived webcast of the event, with slides, may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website. |
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发表于 2018-10-15 19:55