Respiratory Today—October 3, 2025

Respiratory Health Update: Vapendavir COPD Win, WINREVAIR PAH Impact, Taladegib IPF Signals and More

Stay current with key respiratory milestones! This week’s highlights feature Vapendavir’s COPD challenge study showing viral load and lung function benefits, and Merck’s WINREVAIR cutting clinical worsening by 76 percent in PAH. Endeavor Bio’s Taladegib improved FVC and fibrosis imaging in IPF, while Redx and PureTech reported encouraging stabilization signals. Enanta’s zelicapavir and aTyr’s efzofitimod delivered mixed readouts, and Zymeworks advanced a bispecific COPD program. Diagonal Tx added preclinical PAH insights, underscoring momentum across respiratory innovation.

In Today’s Newsletter

💊 Vapendavir human challenge signal in COPD (rhinovirus) [1] [EU • 28 Sep 2025]

https://www.prnewswire.com/news-releases/altesa-biosciences-presents-findings-demonstrating-beneficial-effects-of-vapendavir-for-treating-rhinovirus-infections-in-copd-challenge-study-302568959.html
Context: ERS 2025 late-breaker; 40 COPD patients challenged with rhinovirus; outpatient study model.
Key point: Vapendavir improved PROs, reduced viral load, preserved lung function; well tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Amneal files BLA for Xolair® (omalizumab) biosimilar [2] [US • 26 Sep 2025]

https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-BLA-Submission-of-Biosimilar-Candidate-to-XOLAIR-omalizumab/default.aspx
Context: Kashiv-developed, Amneal exclusive US rights; $4.1B US sales trailing 12 months.
Key point: Early filing positions Amneal for first-wave biosimilar entry; 5 more biosimilars 2026–2027.
Implication: Introduces competition that may affect pricing and formulary access.

🫁 Zelasudil (RXC007; Redx) Phase 2a IPF “signal-searching” data [3] [EU • 29 Sep 2025]

https://www.redxpharma.com/wp-content/uploads/2025/09/RXC007-ERS-data-announcement-29-September-2025.pdf
Context: 48 patients, 12-week DB; 12-week OLE; no SAEs.
Key point: Numerical FVC decline reductions (−47% vs placebo at 20 mg); stabilization in OLE; supportive biomarker data.
Implication: May influence prescriber choice and payer reviews pending full data.

📈 Deupirfenidone (LYT-100; PureTech/Celea) OLE switch cohorts stabilize FVC [4] [EU • 29 Sep 2025]

https://news.puretechhealth.com/news-releases/news-release-details/puretech-presents-new-data-phase-2b-open-label-extension-study
Context: ELEVATE IPF Phase 2b; OLE >170 patients; ERS late-breaker.
Key point: Placebo→LYT-100 +20 mL; pirfenidone→LYT-100 −23 mL over 26 weeks; good tolerability; reg. talks underway.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 DIAG723 (Diagonal Therapeutics) preclinical PAH data at ERS [5] [US • 29 Sep 2025]

https://www.diagonaltx.com/news/diagonal-therapeutics-to-present-new-preclinical-data-demonstrating-disease-modifying-potential-of-diag723-in-pulmonary-arterial-hypertension-at-2025-ers-congress
Context: Sugen-Hypoxia rat PAH model; receptor clustering antibody restores ALK1:BMPRII signaling.
Key point: Prevented PAH, reversed RV hypertrophy, improved hemodynamics; outperformed sildenafil preclinically.
Implication: Signals pipeline investment and modality expansion.

🦠 Zelicapavir (Enanta) Phase 2b in high-risk adult RSV outpatients [6] [US • 29 Sep 2025]

https://www.businesswire.com/news/home/20250929135632/en/Enanta-Pharmaceuticals-Reports-Positive-Topline-Results-from-its-Phase-2b-Study-of-Zelicapavir-for-the-Treatment-of-Respiratory-Syncytial-Virus-RSV-in-High-Risk-Adults
Context: Randomized DBP; HR3 subgroup (COPD, CHF, ≥75) 81%.
Key point: Faster complete symptom resolution (HR3: +6.7 days), improved virology, lower hospitalization; primary endpoint not met.
Implication: May influence prescriber choice and payer reviews pending full data.

📄 Taladegib (ENV-101; Endeavor) IPF Phase 2a in Lancet Respiratory Medicine [7] [US • 30 Sep 2025]

https://endeavorbiomedicines.com/endeavor-biomedicines-announces-publication-of-positive-data-from-phase-2a-trial-in-the-lancet-respiratory-medicine-evaluating-taladegib-env101-in-individuals-with-idiopathic-pulmonary-fibrosis/
Context: 41 patients, 12 weeks, no background SOC; ERS ALERT.
Key point: Significant % predicted FVC benefit (+3.95%, p=0.035), TLC ↑, fibrosis metrics improved; safety favorable.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Efzofitimod (aTyr) Phase 3 EFZO-FIT™ additional findings [8] [US • 30 Sep 2025]

https://investors.atyrpharma.com/news-releases/news-release-details/atyr-pharma-presents-additional-findings-phase-3-efzo-fittm
Context: 268 patients; primary (steroid reduction) not met; ERS late-breaker.
Key point: Nominal gains in fatigue (FAS p=0.0226) & KSQ-General Health (p=0.0197); safety acceptable; KSQ-Lung earlier positive.
Implication: May influence prescriber choice and payer reviews pending full data.

🏁 WINREVAIR™ (sotatercept-csrk; Merck) HYPERION success in early PAH [9] [US • 30 Sep 2025]

https://www.merck.com/news/winrevair-sotatercept-csrk-reduced-the-risk-of-clinical-worsening-events-by-76-compared-to-placebo-in-patients-recently-diagnosed-with-pah-on-background-therapy-in-phase-3-hyperion-trial/
Context: Newly diagnosed PAH (≤12 months), background double/triple therapy; ERS + NEJM.
Key point: 76% risk reduction in clinical worsening (HR 0.24); early benefit by 6 weeks; subgroup consistency; safety aligned.
Implication: May influence prescriber choice and payer reviews pending full data.

🧯 ZW1528 (Zymeworks) IL-4Rα x IL-33 bispecific for COPD inflammation [10] [EU • 29 Sep 2025]

https://www.zymeworks.com/zymeworks-presents-preclinical-data-on-zw1528-at-the-european-respiratory-society-annual-congress/
Context: Preclinical ERS poster; IND 2H-2026 planned.
Key point: Dual blockade exceeded benchmarks in vitro; in vivo biomarker engagement; reduced lung inflammation; favorable PK in NHPs.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Early-PAH HYPERION data support initiating sotatercept on top of background therapy soon after diagnosis.
Multiple IPF approaches (taladegib, deupirfenidone, zelasudil) show signals beyond traditional antifibrotics.
RSV antivirals advance for high-risk adult outpatients, a historical therapeutic gap.
Omalizumab biosimilar activity could reshape access and spend in respiratory-adjacent immunology.

📢 Stay Ahead in Respiratory Health Research!

✅ Contact LucidQuest at info@lqventures.com for strategic guidance on Respiratory Health innovations and clinical research

FAQ

What’s new about WINREVAIR’s evidence base in PAH?

HYPERION adds early-disease data: within 12 months of diagnosis, sotatercept cut clinical worsening by 76% vs placebo on background therapy, with early curve separation and consistent subgroup effects [9].

Did Enanta’s zelicapavir hit its primary endpoint?

No. The primary (time to resolution of LRTD symptoms to mild) wasn’t met. But complete symptom resolution, PGI-S, hospitalization rates, and virology favored zelicapavir, especially in HR3 patients [6].

How strong are Endeavor’s taladegib results for IPF?

In a 12-week randomized Phase 2a (no background SOC), taladegib significantly improved % predicted FVC vs placebo, increased TLC, and improved HRCT fibrosis metrics, with favorable safety; data are peer-reviewed in Lancet Respiratory Medicine [7].

What did PureTech/Celea show with deupirfenidone in the OLE?

Switch cohorts from placebo or pirfenidone to deupirfenidone over 26 weeks showed FVC stabilization (+20 mL / −23 mL, respectively), with continued favorable tolerability; regulatory design discussions are underway [4].

Is Redx’s zelasudil ready for Phase 3?

Phase 2a “signal-searching” data are supportive (numerical FVC benefits, biomarkers, SOC combinability, tolerability). Redx is seeking a partner for next steps [3].

What’s the significance of Amneal’s omalizumab biosimilar BLA?

Positions Amneal/Kashiv for potential first-wave US entry, potentially affecting pricing and access once approved [2].

Entities / Keywords

Merck; WINREVAIR™; sotatercept-csrk; HYPERION; PAH; Enanta; zelicapavir; RSV; HR3 subgroup; RiiQ™; PGI-S; Endeavor BioMedicines; taladegib; ENV-101; IPF; TLC; HRCT; PureTech Health; Celea Therapeutics; deupirfenidone; LYT-100; ELEVATE IPF; OLE; Redx Pharma; zelasudil; RXC007; ROCK2 inhibitor; PRO-C3; CHI3L1; Amneal; Kashiv BioSciences; omalizumab; Xolair®; biosimilar; Altesa BioSciences; vapendavir; COPD; rhinovirus challenge; aTyr Pharma; efzofitimod; EFZO-FIT™; pulmonary sarcoidosis; KSQ; FAS; Diagonal Therapeutics; DIAG723; ALK1; BMPRII; Sugen-Hypoxia; Zymeworks; ZW1528; IL-4Rα; IL-33; Azymetric™; COPD.