Respiratory Today—November 28, 2025

Explore this week’s respiratory highlights, including new developments, pipeline updates, and progress from biopharma leaders.

In Today’s Newsletter

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🫀 Inhibikase moves IKT-001 into single pivotal Phase 3 in PAH [1] [US • 20 Nov 2025]

https://www.inhibikase.com/news/press-releases/detail/135/inhibikase-therapeutics-advancing-ikt-001-to-global-phase-3

Context: Pivot from planned Phase 2b to an adaptive Phase 3, IMPROVE-PAH; initiation Q1 2026.

Key point: Part A (n=140) primary endpoint PVR at Week 24; Part B (n=346) primary endpoint 6MWD at Week 24; 12-week dose-titration.

Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.

🌬️ Glenmark launches world-first nebulized fixed-dose triple for COPD [2] [IN • 25 Nov 2025]

https://glenmark.b-cdn.net/gpl_pdfs/media/Press%20Release%20-%20Glenmark%20Pharmaceuticals%20Announces%20World%E2%80%99s%20First%20Nebulized%20Triple%20Therapy%20for%20COPD.pdf

Context: India launch of Nebzmart GFB Smartules and Glenmark Airz FB Smartules.

Key point: Fixed-dose Glycopyrronium, Formoterol, Budesonide in a nebulized format; local study showed rapid lung-function improvement and dyspnea control (numbers not stated).

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

🤝 Flagship Pioneering and GSK sign first feasibility agreements [3] [US • 20 Nov 2025]

https://www.prnewswire.com/news-releases/flagship-pioneering-announces-new-agreements-with-profound-therapeutics-and-quotient-therapeutics-under-its-collaboration-with-gsk-302621224.html

Context: ProFound to mine expanded proteome for COPD/IPF targets; Quotient to apply somatic genomics across COPD, IPF, MASH.

Key point: If progressed, GSK holds exclusive option after preclinical advancement by partners.

Implication: Partnerships/BD. Signals pipeline investment and modality expansion.

🧫 BiomX BX004 CF trial: FDA device hold persists, dosing adjusted per DMC [4] [IL • 25 Nov 2025]

https://ir.biomx.com/news-releases/news-release-details/biomx-provides-update-bx004-phase-2b-trial-cystic-fibrosis

Context: Hold relates to third-party nebulizer; sponsor assembling additional information for FDA.

Key point: DMC reviewed AEs, recommended continuation with adjusted dosing; topline now expected Q2 2026.

Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.

🧪 Qilu starts Phase 1 PK similarity study for QL2302 vs Tezspire [5] [CN • 25 Nov 2025]

https://finance.sina.cn/2025-11-25/detail-infyqumz4940705.d.html

Context: CTR20254685; randomized, double-blind, parallel, positive-controlled in healthy adults; target n=178.

Key point: Single subcutaneous dose 1.91 ml; primary endpoints Cmax and AUC0–∞; program aimed at severe asthma maintenance.

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

Why it matters

Adaptive single-pivotal design in PAH can compress timelines and align endpoints with hemodynamics and function [1].
A nebulized triple FDC could broaden COPD access for patients who struggle with MDI/DPI technique [2].
Platform collaborations may accelerate novel target discovery in COPD and IPF where mechanisms remain heterogeneous [3].
Managing device dependencies is critical for inhaled phage development in CF, with dosing refinements ongoing [4].
A potential Tezspire-referenced biologic signals future competition in severe asthma biologics in China and beyond [5].

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FAQ

What is the primary readout for Inhibikase’s IMPROVE-PAH study?

Part A focuses on pulmonary vascular resistance at Week 24; Part B focuses on 6-minute walk distance at Week 24, with dose-titration over 12 weeks [1].

What exactly did Glenmark launch for COPD?

Two nebulized fixed-dose triple products, combining Glycopyrronium, Formoterol, and Budesonide, positioned as the first known nebulized triple therapy for COPD in India [2].

How do the Flagship–GSK feasibility deals work?

ProFound and Quotient run discovery and validation. If GSK elects to proceed, they can take programs forward after preclinical milestones with exclusive options [3].

Why is BiomX’s BX004 trial on clinical hold?

The FDA is evaluating the third-party nebulizer device. A DMC endorsed continuation with adjusted dosing, and topline timing shifted to Q2 2026 [4].

What is Qilu’s QL2302 study comparing?

PK similarity of a single subcutaneous dose of QL2302 versus Tezspire in healthy adults. Primary endpoints are Cmax and AUC0–∞, with additional PK parameters as secondary endpoints [5].

Entities / Keywords

Inhibikase Therapeutics; IKT-001; imatinib prodrug; PAH; IMPROVE-PAH • Glenmark Pharmaceuticals; Nebzmart GFB Smartules; Glenmark Airz FB Smartules; COPD; nebulized triple therapy; Glycopyrronium; Formoterol; Budesonide • 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; PK similarity; CTR20254685.