Respiratory Video Recap—November 28, 2025

LucidQuest

2 days ago

This respiratory video recap covers regulatory approvals, pediatric safety readouts, Phase 3 trial initiations, payer-aligned support programs, early-stage feasibility deals, and development setbacks—plus more respiratory and inflammatory disease news.

🎯 Watch Our Video Summary Capturing Respiratory News from the Last Two Weeks

🗓️ Explore weekly details and sources

Week 14–20 November 2025
Week 21–27 November 2025

📚 See the full Respiratory archive on our research hub page.

Transcript

Welcome to the latest edition of Respiratory Research Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

Cipla USA extended its partnership with the COPD Foundation for a third year, launching World COPD Day initiatives including the Blow Art Challenge, Lace-Up for Lungs, and an Orange Day awareness drive. The effort aims to boost community engagement and access for people living with COPD in the United States.

Insmed announced European Commission approval of BRINSUPRI, brensocatib 25 mg tablets, for non-cystic fibrosis bronchiectasis in patients 12 years and older with two or more exacerbations in the past year. Reviewed under accelerated assessment, the decision was supported by ASPEN and WILLOW data, including a 19.4% reduction in annual exacerbation rate versus placebo and improvements in time to first exacerbation.

New interim data from IMPAACT 2034 showed that a single dose of pretomanid in female children with rifampicin-resistant TB achieved adult-comparable pharmacokinetics and was well tolerated. The Phase 1 study enrolled 28 participants in South Africa and Thailand, using weight-based cohorts and both adult and pediatric dispersible tablets, with plans to include male children in later multidose work.

Partners Health Management launched Free2BREATHE across 15 North Carolina counties to support youth with asthma. Eligible members aged 0 to 18 can receive allergen-barrier mattress covers and pillowcases at no cost to reduce nighttime triggers and improve symptom control.

Inhibikase Therapeutics will initiate IMPROVE-PAH, a single, adaptive global Phase 3 of IKT-001 in pulmonary arterial hypertension, in the first quarter of 2026. Part A will assess pulmonary vascular resistance at Week 24 in approximately 140 patients, and Part B will assess 6-minute walk distance at Week 24 in approximately 346 patients, with a 12-week dose-titration phase, uninterrupted enrollment, and up to about 180 global sites.

Flagship Pioneering and GSK signed the first feasibility agreements under their framework collaboration, involving ProFound Therapeutics and Quotient Therapeutics. ProFound will mine the expanded proteome for COPD and IPF targets, while Quotient applies somatic genomics to COPD, IPF, and MASH, with GSK holding exclusive options after preclinical advancement.

BiomX reported that the FDA continues evaluating the third-party nebulizer used in its Phase 2b BX004 cystic fibrosis trial, maintaining a US clinical hold. An independent data monitoring committee recommended continuing the study with an adjusted dosing regimen, and topline results are now expected in the second quarter of 2026.

Qilu Pharmaceutical initiated a randomized, double-blind, parallel, positive-controlled Phase 1 PK similarity study of QL2302 versus Tezspire in healthy adults. The single 1.91 mL subcutaneous dose trial (CTR20254685) focuses on Cmax and AUC0–∞ as primary endpoints, targets enrollment of 178 participants, and supports a severe asthma maintenance indication.

Stay ahead in Respiratory Research! Like, share, and subscribe for our updates. Visit www.lqventures.com or email us at info@lqventures.com for expert healthcare consulting. See you next time!

Why It Matters

First-in-disease EU approval reshapes the NCFB landscape and sets up 2026 access negotiations [2].
Pediatric RR-TB development is moving toward child-friendly regimens, addressing a long-standing gap [3].
Adaptive single-pivotal design in PAH aligns hemodynamic and functional endpoints while compressing timelines [5].
Device dependencies can drive trial risk in inhaled therapies; BiomX illustrates mitigation via protocol and dosing updates [7].
Potential tezepelumab-referenced biologic competition signals future pressure in severe asthma markets [8].

🗓️ Explore weekly details and sources

Week 14 –20 November 2025
Week 21–27 November 2025

📚 See the full Respiratory archive on our research hub page.

FAQ

What exactly did the EU approve for bronchiectasis?

BRINSUPRI (brensocatib 25 mg) for non-cystic fibrosis bronchiectasis in patients 12+ with two or more exacerbations in the prior 12 months, reviewed under accelerated assessment [2].

What is Inhibikase’s Phase 3 IMPROVE-PAH design?

Two-part adaptive study: Part A primary endpoint PVR at Week 24, Part B primary endpoint 6MWD at Week 24, with a 12-week dose-titration and uninterrupted enrollment between parts [5].

What did IMPAACT 2034 show for pretomanid in children?

A single dose in female children with RR-TB produced adult-comparable exposures and was well tolerated, supporting progression to multidose pediatric studies [3].

Why is BiomX’s BX004 trial on hold in the US?

FDA is evaluating the third-party nebulizer device used for administration. A DMC endorsed continuation with adjusted dosing, with topline now expected in Q2 2026 [7].

What is Qilu testing with QL2302?

PK similarity of a single subcutaneous dose versus Tezspire in healthy adults, with Cmax and AUC0–∞ as primary endpoints for a severe asthma maintenance program [8].

What is Cipla USA doing with the COPD Foundation?

Extending the partnership for a third year and running awareness initiatives tied to World COPD Day to boost community engagement (endpoint not specified) [1].

Entities / Keywords

Cipla USA; COPD Foundation; COPD awareness • Insmed; BRINSUPRI; brensocatib; NCFB; EC approval; ASPEN; WILLOW • TB Alliance; pretomanid; IMPAACT 2034; rifampicin-resistant TB; pediatric PK • Partners Health Management; Free2BREATHE; pediatric asthma; allergen-barrier bedding • Inhibikase Therapeutics; IKT-001; imatinib prodrug; PAH; IMPROVE-PAH • Flagship Pioneering; GSK; ProFound Therapeutics; Quotient Therapeutics; COPD; IPF; MASH; somatic genomics; expanded proteome • BiomX; BX004; cystic fibrosis; Pseudomonas aeruginosa; phage therapy; DMC; FDA device hold • Qilu Pharmaceutical; QL2302; tezepelumab (Tezspire); severe asthma; CTR20254685.