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July 6, 2022

Arrowhead doses subjects in two Phase I/IIa pulmonary disease trials

Both trials will analyse the safety and tolerability, pharmacokinetics and pharmacodynamics of the two RNAi therapeutics.

Arrowhead Pharmaceuticals has dosed the first participants in two Phase I/IIa clinical trials of pulmonary candidates, ARO-MUC5AC and ARO-RAGE, to potentially treat various muco-obstructive and inflammatory pulmonary diseases, respectively.

ARO-MUC5AC and ARO-RAGE are two investigational ribonucleic acid interference (RNAi) therapeutics intended to lower the production of mucin 5AC (MUC5AC) and the receptor for advanced glycation end products (RAGE).

One of the trials is named AROMUC5AC-1001. This double-blinded, randomised, placebo-controlled trial will enrol up to 42 normal healthy volunteers (NHV) and up to 16 moderate-to-severe asthma patients.

The single ascending dose portion of the trial will comprise three sequentially enrolled NHV cohorts with escalating single-dose levels. 

Three NHV cohorts and two asthma patient cohorts will comprise the multiple ascending dose portion of the trial.

Analysing the safety and tolerability, pharmacokinetics and pharmacodynamics of ARO-MUC5AC in NHVs and asthma patients are the goals of the trial.

The other study is a Phase I/IIa double-blinded, placebo-controlled, randomised ARORAGE-1001 trial enrolling up to 64 healthy subjects and up to 16 mild-to-moderate asthma patients. 

The single ascending dose portion of this trial will have four sequentially enrolled NHV cohorts as well as an optional cohort receiving escalating single-dose levels. 

Its multiple ascending dose portion will include four NHV cohorts and two asthma patient cohorts. 

Evaluating the safety and tolerability, pharmacokinetics and pharmacodynamics of ARO-RAGE in NHVs and asthma patients are the objectives of this trial. 

Arrowhead Pharmaceuticals president and CEO Chris Anzalone said: “Initiating clinical studies for ARO-MUC5AC and ARO-RAGE, Arrowhead’s next-generation pulmonary targeted RNAi therapeutic candidates, is a significant milestone for the company. 

“These are potentially important new medicines that address targets that have been difficult to drug using other modalities and are designed to treat muco-obstructive and inflammatory lung diseases in fundamentally new ways.”

In February this year, the company concluded the participant enrolment as planned in the Phase IIb trial of ARO-ANG3 for treating mixed dyslipidemia patients.

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