This week’s Respiratory update highlights clinical trial progress, regulatory approvals, product launches, and emerging modalities across infectious and chronic lung diseases.
In Today’s Newsletter
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🌬️ Avalyn starts AURA for AP02 in IPF [1] [US • 23 Mar 2026]
https://www.globenewswire.com/news-release/2026/03/23/3260821/0/en/Avalyn-Announces-First-Patient-Dosed-in-AURA-Phase-2-Clinical-Trial-Evaluating-AP02-Inhaled-Nintedanib-for-the-Treatment-of-Idiopathic-Pulmonary-Fibrosis.html
Context: Avalyn Pharma is testing AP02, inhaled nintedanib delivered via the PARI eFlow nebulizer, in idiopathic pulmonary fibrosis.
Key point: Avalyn announced initiation of the randomized, double-blind, placebo-controlled AURA Phase 2 trial, expected to enroll 160 untreated IPF patients across two dose levels versus placebo.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 Insmed posts positive ENCORE topline for ARIKAYCE in MAC lung disease [2] [US • 23 Mar 2026]
https://investor.insmed.com/2026-03-23-Insmed-Announces-Positive-Topline-Results-from-Phase-3b-ENCORE-Study-of-ARIKAYCE-R-Amikacin-Liposome-Inhalation-Suspension-in-Patients-with-MAC-Lung-Disease
Context: ENCORE randomized 425 patients with new MAC lung infection to ARIKAYCE plus azithromycin and ethambutol, or placebo plus multidrug therapy.
Key point: Insmed said ENCORE met the primary endpoint on respiratory symptom score and all multiplicity-controlled secondary culture conversion endpoints; the company plans an sNDA filing and PMDA submission in 2H 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Beam advances BEAM-302 toward pivotal development in AATD [3] [US • 25 Mar 2026]
https://investors.beamtx.com/news-releases/news-release-details/beam-therapeutics-announces-compelling-updated-clinical-data
Context: BEAM-302 is a liver-targeting base-editing candidate designed to correct the PiZ mutation in alpha-1 antitrypsin deficiency.
Key point: Beam reported updated Phase 1/2 data, selected 60 mg as the optimal biological dose, and said a global pivotal cohort is expected to start in 2H 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Shionogi wins Japan prophylaxis label expansion for XOCOVA [4] [Japan • 23 Mar 2026]
https://www.shionogi.com/global/en/news/2026/03/20260323_1.html
Context: The supplemental indication is for post-exposure prophylaxis of COVID-19 and is based on the Phase 3 SCORPIO-PEP study.
Key point: Shionogi said XOCOVA (ensitrelvir fumaric acid) became the first oral antiviral approved in Japan for COVID-19 post-exposure prophylaxis.
Implication: Introduces competition that may affect pricing and formulary access.
📊 Avalyn publishes AP01 imaging analysis in IPF [5] [US • 25 Mar 2026]
https://www.globenewswire.com/news-release/2026/03/25/3262138/0/en/Avalyn-Announces-Publication-Demonstrating-Correlation-Between-Imaging-Improved-Lung-Function-and-Quality-of-Life-with-AP01-in-Patients-with-Idiopathic-Pulmonary-Fibrosis.html
Context: The analysis is a post-hoc readout from the Phase 1b ATLAS trial of AP01, inhaled pirfenidone, and used quantitative HRCT in collaboration with UCLA.
Key point: Avalyn said the publication showed correlation between imaging changes, lung function, and quality of life in AP01-treated IPF patients, with more than 70% of evaluable patients on AP01 100 mg twice daily showing fibrosis stabilization or improvement at Week 24.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🤧 Sandoz launches azelastine/fluticasone nasal spray in Germany and Switzerland [6] [EU • 23 Mar 2026]
https://www.sandoz.com/sandoz-launches-azelastinefluticasone-nasal-spray-germany-and-switzerland-expanding-patient-access/
Context: The fixed-dose combination is positioned as an alternative to Dymista and expands Sandoz allergy care in two European markets.
Key point: Sandoz launched azelastine/fluticasone nasal spray in Germany and Switzerland ahead of the 2026 allergy season.
Implication: Introduces competition that may affect pricing and formulary access.
🧴 Zydus launches foldable pMDI spacer, Aerolife Mini [7] [India • 19 Mar 2026]
https://zyduslife.com/investor/admin/uploads/21/83/Zydus-launches-Aerolife-Mini—to-simplify-inhaler-use-for-asthma-and-COPD-patients.pdf
Context: Aerolife Mini is an inhaler enhancer launched under an exclusive licensing arrangement with AeroDel Technology Innovations.
Key point: Zydus said Aerolife Mini is India’s first portable, foldable next-generation pMDI enhancer, aimed at simplifying inhaler use in asthma and COPD.
Implication: May expand screening, initiation, and follow-up at scale.
🦠 Interna signs Oxford challenge-trial deal for intranasal siRNA COVID prophylaxis [8] [Israel • 23 Mar 2026]
https://interna.bio/news/interna-therapeutics-announces-human-challenge-trial-agreement-with-the-university-of-oxford-to-advance-intranasal-mnm-sirna-sars-cov-2-prophylaxis-program/
Context: Interna Therapeutics is developing an intranasal Molecular Nano-Motor siRNA candidate targeting SARS-CoV-2, with Gates Foundation support.
Key point: Interna said it signed an agreement with the University of Oxford to run a Phase IIa human challenge trial evaluating antiviral efficacy, safety, and prophylactic potential in healthy volunteers.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Respiratory drug delivery is the common thread, from inhaled antifibrotics and inhaled antibiotics to intranasal RNA therapeutics and inhaler-support devices.
- Avalyn placed two separate markers this week, a new interventional Phase 2 start for AP02 and a publication package supporting biomarker and imaging strategy for AP01.
- Insmed’s ENCORE topline could broaden ARIKAYCE beyond refractory MAC lung disease and strengthen its regulatory position in the US and Japan.
- Beam’s BEAM-302 update stands out for moving a one-time editing approach in AATD closer to pivotal development, with biomarker-driven regulatory planning.
- Commercial access stories from Sandoz and Zydus show that respiratory competition is not only about novel molecules, but also formulation, device design, and route-to-patient convenience.
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FAQ
What is AP02 from Avalyn Pharma, and what happened this week?
AP02 is Avalyn’s inhaled nintedanib program for idiopathic pulmonary fibrosis. This week, Avalyn announced the AURA Phase 2 trial had started, with first patient dosed and 160 patients expected overall [1].
Why does ARIKAYCE matter in the ENCORE study?
ARIKAYCE (Insmed) is already used in a limited refractory MAC lung disease setting. ENCORE reported positive topline results in patients with a new MAC infection, which could support label expansion and traditional approval in the US [2].
What did Beam actually show for BEAM-302?
Beam reported updated Phase 1/2 data in alpha-1 antitrypsin deficiency, selected 60 mg as the optimal biological dose, and said pivotal development is expected to begin in the second half of 2026 [3].
What changed for XOCOVA in Japan?
Shionogi said Japan approved a supplemental indication for XOCOVA for post-exposure prophylaxis of COVID-19, based on SCORPIO-PEP. The company also noted ongoing US and EU regulatory review paths [4].
How strong is the AP01 evidence from Avalyn?
The AP01 story is a peer-reviewed, post-hoc analysis from the Phase 1b ATLAS trial, not a new randomized efficacy readout. It links quantitative HRCT findings with lung function and quality-of-life trends, so it is best read as supportive, hypothesis-strengthening evidence [5].
Is the Interna Oxford study a registrational trial?
No. Interna described it as a Phase IIa human challenge trial in healthy adult volunteers, designed to generate rapid efficacy and safety data for its intranasal MNM-siRNA program [8].
Entities / Keywords
Avalyn Pharma: Avalyn, AP01, inhaled pirfenidone, AP02, inhaled nintedanib, AURA, ATLAS, MIST, IPF, PPF
Insmed: ARIKAYCE, amikacin liposome inhalation suspension, ENCORE, MAC lung disease
Beam Therapeutics: BEAM-302, AATD, alpha-1 antitrypsin deficiency, PiZ, base editing, M-AAT, Z-AAT
Shionogi: XOCOVA, ensitrelvir, SCORPIO-PEP, COVID-19 post-exposure prophylaxis
Sandoz: azelastine/fluticasone, allergy nasal spray, Dymista alternative, Germany, Switzerland
Zydus Lifesciences: Aerolife Mini, AeroDel, pMDI enhancer, spacer, asthma, COPD
Interna Therapeutics: MNM-siRNA, Molecular Nano-Motor, intranasal siRNA, Oxford human challenge trial, SARS-CoV-2 prophylaxis
References
- https://www.globenewswire.com/news-release/2026/03/23/3260821/0/en/Avalyn-Announces-First-Patient-Dosed-in-AURA-Phase-2-Clinical-Trial-Evaluating-AP02-Inhaled-Nintedanib-for-the-Treatment-of-Idiopathic-Pulmonary-Fibrosis.html
- https://investor.insmed.com/2026-03-23-Insmed-Announces-Positive-Topline-Results-from-Phase-3b-ENCORE-Study-of-ARIKAYCE-R-Amikacin-Liposome-Inhalation-Suspension-in-Patients-with-MAC-Lung-Disease
- https://investors.beamtx.com/news-releases/news-release-details/beam-therapeutics-announces-compelling-updated-clinical-data
- https://www.shionogi.com/global/en/news/2026/03/20260323_1.html
- https://www.globenewswire.com/news-release/2026/03/25/3262138/0/en/Avalyn-Announces-Publication-Demonstrating-Correlation-Between-Imaging-Improved-Lung-Function-and-Quality-of-Life-with-AP01-in-Patients-with-Idiopathic-Pulmonary-Fibrosis.html
- https://www.sandoz.com/sandoz-launches-azelastinefluticasone-nasal-spray-germany-and-switzerland-expanding-patient-access/
- https://zyduslife.com/investor/admin/uploads/21/83/Zydus-launches-Aerolife-Mini—to-simplify-inhaler-use-for-asthma-and-COPD-patients.pdf
- https://interna.bio/news/interna-therapeutics-announces-human-challenge-trial-agreement-with-the-university-of-oxford-to-advance-intranasal-mnm-sirna-sars-cov-2-prophylaxis-program/