Arrowhead Pharmaceuticals

The nanomedicine market was valued at USD 223.6 billion in 2023 and is projected to reach USD 634.2 billion by 2032, with a CAGR of 12.2%. This growth is driven by increased demand for advanced drug delivery systems and rising chronic disease incidence. North America leads the market, while Asia-Pacific is expected to grow the fastest.

The nanomedicine market, valued at USD 223.6 billion in 2023, is projected to reach USD 634.2 billion by 2032, driven by advanced drug delivery systems and rising chronic diseases. Key players include Johnson & Johnson, Mallinckrodt Pharmaceuticals, and Teva Pharmaceutical Industries. Recent developments include Novartis's nanoparticle-based ovarian cancer treatment and Merck's partnership with Stanford for immunotherapy research.

In a randomized clinical trial with 797 adults, no significant differences were found between once-daily vs more frequent screening and pressure-supported vs T-piece SBTs for time to successful extubation. However, a significant interaction was identified: more frequent screening with pressure-supported SBTs increased the time to successful extubation, while once-daily screening with pressure-supported SBTs did not reduce this time compared to T-piece SBTs.

September 2024 saw significant developments in cardiology, including the ESC Congress 2024 and FDA approvals like plozasiran for familial chylomicronemia syndrome. Edgewise Therapeutics reported positive data for EDG-7500 in hypertrophic cardiomyopathy. ESC Congress 2024 featured 4,400 abstracts and 32,000 attendees, highlighting new data on finerenone, milvexian, and aficamten. The Family Heart Global Summit in Dallas also provided insights on lipoprotein(a) therapies. The APAC Recap series, a collaboration with the Academy of Physician Associates in Cardiology, shared key takeaways from medical meetings.

Familial chylomicronemia syndrome (FCS) lacks approved therapies, but olezarsen and plozasiran show promise in phase 3 trials. Olezarsen, an antisense oligonucleotide, and plozasiran, a small interfering RNA, both demonstrated significant triglyceride reduction and reduced pancreatitis risk in FCS patients.

Arrowhead Pharmaceuticals has applied to launch a Phase I/IIa trial of ARO-INHBE, an RNAi therapy for obesity, in New Zealand. The study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in up to 78 obese adult subjects, both diabetic and non-diabetic. The trial will evaluate ARO-INHBE as a standalone treatment and in combination with tirzepatide, a medication for type 2 diabetes and weight control. ARO-INHBE targets the INHBE gene to reduce Activin E secretion, which regulates energy balance in fat tissue.

Arrowhead Pharmaceuticals filed for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-INHBE, an RNAi therapeutic for obesity, and plans to file for ARO-ALK7 by 2024. Preclinical studies suggest ARO-INHBE reduces body weight and fat mass while preserving lean muscle mass.

FDA approves OTC hearing aid software for Apple AirPods, based on study with 118 adults showing comparable performance to professional aids. Also, FDA approves Tremfya for active ulcerative colitis, with 50% of patients achieving clinical remission. Additionally, plozasiran receives FDA breakthrough therapy designation for familial chylomicronemia syndrome.

Arrowhead Pharmaceuticals granted breakthrough therapy designation by FDA for plozasiran, an RNAi therapeutic showing promising results in reducing triglycerides and atherogenic lipoproteins. Intended for use with a healthy diet in adults with familial chylomicronaemia syndrome (FCS), plozasiran also reduces apolipoprotein C-III (APOC3) production. Arrowhead aims to submit a new drug application to the FDA by year-end.

FDA grants breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, an RNAi therapeutic for familial chylomicronemia syndrome (FCS), aiming to reduce triglycerides by targeting apolipoprotein C-III (APOC3). The designation expedites drug development and review for serious conditions. Plozasiran has shown promising results in clinical studies and is part of the SUMMIT programme, with a planned FDA submission by end of 2024.