Respiratory Weekly News—September 12th, 2025

LucidQuest

2 months ago

This Week in Respiratory Health: Orphan Drugs, Asthma Campaigns, Phage Science, and COPD Breakthroughs and More.

From orphan designations in Japan to national asthma prevention efforts and next-gen COPD trials, this week’s Respiratory Health Updates highlights the clinical and regulatory milestones shaping pulmonary care.

In Today’s Newsletter

🌐 Pulmovant wins orphan drug nod in Japan for mosliciguat [1] [JP • 04 Sep 2025]

https://www.pulmovant.com/press-release-september-4-2025

Key point: Japan’s MHLW granted orphan designation to mosliciguat (inhaled sGC activator) for PH-ILD.

Context: Based on PMDA recommendation; provides up to 10 years exclusivity. Global Phase 2 PHocus study ongoing (n≈120).

Implication: Introduces competition that may affect pricing and formulary access.

🤝 Aptar + Dianosic intranasal scaffold alliance [2] [FR • 05 Sep 2025]

https://aptar.com/news-events/aptar-pharma-and-dianosic-announce-exclusive-partnership-to-advance-the-active-resorbable-intranasal-scaffold-platform-for-the-treatment-of-chronic-allergic-rhinitis-and-chronic-rhinosinusitis/

Key point: Aptar Pharma formed exclusive partnership with Dianosic to advance ARIS scaffold for CAR/CRS.

Context: Resorbable insert designed for long-acting intranasal delivery; partnership also explores nose-to-brain applications.

Implication: Signals pipeline investment and modality expansion.

🫁 NHS launches campaign to cut child asthma deaths [3] [UK • 07 Sep 2025]

https://www.echo-news.co.uk/news/25438635.nhs-launches-campaign-reduce-childhood-asthma-deaths/

Key point: NHS rolled out regional asthma campaign across East of England, timed to seasonal hospital admissions peak.

Context: Focus on action plans, inhaler technique, regular reviews, and air quality awareness.

Implication: May expand screening, initiation, and follow-up at scale.

🔬 Armata publishes phage Pa223 structure [4] [US • 08 Sep 2025]

https://investor.armatapharma.com/2025-09-08-Armata-Pharmaceuticals-Announces-Structural-Biology-Publication-in-the-Journal-of-Molecular-Biology

Key point: Armata reported cryo-EM structure of Pseudomonas phage Pa223, part of AP-PA02 cocktail.

Context: AP-PA02 previously tested in two Phase 2 trials in chronic respiratory infections.

Implication: May influence prescriber choice and payer reviews pending full data.

💊 AstraZeneca starts Phase 2b UMBRIEL asthma trial [5] [CN • 09 Sep 2025]

https://www.vbdata.cn/intelDetail/788580

Key point: AstraZeneca initiated Phase 2b study of tozorakimab in adults with poorly controlled asthma.

Context: Randomized, double-blind trial (n≈600 global; registry CTR20253511); primary endpoint severe exacerbation rate.

Implication: May influence prescriber choice and payer reviews pending full data.

⚡ NS-229 granted FDA Fast Track for EGPA [6] [US • 09 Sep 2025]

https://www.nspharma.com/fda-grants-fast-track-designation-to-ns-229-for-the-treatment-of-eosinophilic-granulomatosis-with-polyangiitis/

Key point: FDA granted Fast Track to NS-229 (JAK1 inhibitor) for eosinophilic granulomatosis with polyangiitis.

Context: Follows April 2025 orphan designation; global Phase 2 placebo-controlled trial ongoing.

Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Altesa + bioMérieux partner on COPD trial [7] [US/UK • 09 Sep 2025]

https://www.prnewswire.com/news-releases/altesa-biosciences-and-biomerieux-announce-collaboration-for-altesas-upcoming-phase-2b-copd-clinical-trial-302549995.html

Key point: Altesa to use bioMérieux’s SPOTFIRE diagnostic in Phase 2b COPD trial of vapendavir.

Context: Planned for Q1 2026; n=600 GOLD II–IV COPD; randomized, placebo-controlled. Vapendavir targets rhinovirus-triggered exacerbations.

Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

Why it matters

Japan’s orphan designation expands Pulmovant’s regulatory runway in PH-ILD.
Aptar and Dianosic broaden nasal delivery into chronic rhinitis and CNS.
NHS highlights preventable asthma deaths and promotes adherence basics.
Armata strengthens phage therapy credibility with structural biology data.
AstraZeneca adds mid-stage evidence for IL-33 antibody in uncontrolled asthma.
NS Pharma gains expedited path for rare autoimmune vasculitis therapy.
Altesa links point-of-care diagnostics with antiviral COPD trial design.

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FAQ

What is mosliciguat and why is Pulmovant advancing it?

Mosliciguat is an inhaled sGC activator for pulmonary hypertension associated with interstitial lung disease. Pulmovant, a Roivant company, is studying it in the global Phase 2 PHocus trial [1].

What does the Aptar–Dianosic alliance involve?

Aptar is investing in Dianosic and co-developing the ARIS intranasal scaffold for chronic allergic rhinitis and chronic rhinosinusitis, with future nose-to-brain applications [2].

How is the NHS targeting asthma mortality?

Through a regional campaign emphasizing action plans, inhaler technique, and routine reviews. The effort is concentrated in the East of England during peak admissions [3].

What did Armata reveal about AP-PA02?

It published the cryo-EM structure of phage Pa223, part of its multi-phage candidate AP-PA02, which has already been tested in two Phase 2 trials [4].

What is tozorakimab being tested for?

AstraZeneca is running the Phase 2b UMBRIEL study in adults with poorly controlled asthma, assessing exacerbation outcomes and safety [5].

What is NS-229’s regulatory status?

The FDA granted Fast Track designation to NS-229, a JAK1 inhibitor, for eosinophilic granulomatosis with polyangiitis. It also has orphan designation since April 2025 [6].

How will Altesa use SPOTFIRE in its COPD trial?

Altesa’s Phase 2b trial will use bioMérieux’s SPOTFIRE point-of-care test to quickly confirm rhinovirus infections before randomizing patients to vapendavir or placebo [7].

Entities / Keywords

Pulmovant (Roivant); mosliciguat; PH-ILD; Aptar Pharma; Dianosic; ARIS scaffold; NHS England; childhood asthma; Armata Pharmaceuticals; AP-PA02; phage Pa223; AstraZeneca; tozorakimab; UMBRIEL trial; NS Pharma; Nippon Shinyaku; NS-229; EGPA; Altesa BioSciences; vapendavir; bioMérieux; BIOFIRE SPOTFIRE; COPD.