Stay informed with this biweekly overview of the latest in respiratory. We cover new trial data, acquisitions, approvals and important company developments.
Watch Our Video Summary Capturing Respiratory News from the Last Two Weeks
💡 Savara’s IMPALA-2 Results at CHEST 2025
Context: Savara will showcase encore Phase 3 data on molgramostim for aPAP at CHEST 2025, along with partner TrilliumBiO’s assay data.
Key Point: Focus on efficacy by disease severity and HRQoL links.
Implication: Data may influence prescriber choices and payer decisions pending full data.
🦠 Invivyd’s US IND Clearance for VYD2311
Context: VYD2311 program to prevent COVID via IM dosing; Phase 3 and Phase 2 trials outlined.
Key Point: Alignment with FDA on pivotal trials with anticipated top-line data in mid-2026.
Implication: Advances antibody-based prevention against COVID, influencing future treatment options.
💸 Merck Completes Verona Pharma Acquisition
https://www.merck.com/news/merck-completes-acquisition-of-verona-pharma/
Context: Merck completes ~$10B acquisition of Verona Pharma, adds Ohtuvayre (ensifentrine) for COPD.
Key Point: Strengthens Merck’s portfolio with a first-in-class PDE3/4 inhibitor for COPD maintenance.
Implication: Potential for new COPD treatment options and market expansion for Merck.
🌬️ Boehringer Ingelheim’s Jascayd Approved for IPF
Context: Jascayd (nerandomilast), the first new FDA-approved treatment for IPF in over a decade.
Key Point: Demonstrates a tolerability edge over older treatments; limited survival benefit observed.
Implication: May reshape IPF treatment protocols and influence prescriber preferences.
🔬 4DMT Advances 4D-710 with Cystic Fibrosis Foundation Support
Context: 4DMT receives up to $11M to accelerate 4D-710 into Phase 2 with Cystic Fibrosis Foundation support.
Key Point: Focus on durable genetic medicine for CF lung disease, with redosing planned.
Implication: Advancements could lead to a foundational therapy for CF treatment.
💔 Tvardi’s Preliminary Data from TTI-101 in IPF
Context: Mixed Phase 2 results for TTI-101 in IPF, with high variability in efficacy and safety.
Key Point: No significant improvement in FVC observed; gastrointestinal adverse events lead to higher discontinuation.
Implication: Further analysis required to determine next steps in clinical development.
💨 Chiesi’s Triple Combo Inhaler NDA Accepted by FDA
Context: FDA acceptance of Chiesi’s triple combination inhaler for asthma maintenance treatment.
Key Point: Aimed to address uncontrolled asthma, following approval in over 50 countries.
Implication: Potential new option for asthma patients, expanding Chiesi’s respiratory portfolio in the US.
💶 Leyden Labs Adds €30M for Pan-Influenza Nasal Spray
Context: Leyden Labs receives €30M equity from EIC Fund and Invest-NL to advance pan-influenza nasal spray and mucosal pipeline.
Key Point: Funding strengthens Europe’s pandemic preparedness and expands global investor base.
Implication: Signals pipeline investment and modality expansion, with potential for strategic partnerships.
Why It Matters
- COPD and IPF Treatments: The landscape is evolving with novel therapies like ensifentrine and nerandomilast, bringing fresh options for patients and healthcare providers.
- COVID-19 Prevention: Antibody-based treatments, such as VYD2311, may reshape prevention strategies, offering an alternative to mRNA vaccines.
- Cystic Fibrosis: 4DMT’s 4D-710 offers hope for a durable, redosable genetic solution to CF, moving closer to Phase 2 with support from the Cystic Fibrosis Foundation.
- New Asthma Options: Chiesi’s triple therapy may significantly impact asthma management by offering a convenient, single-inhaler treatment for complex cases.
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FAQ
What is the significance of Savara’s IMPALA-2 results?
Savara will present encore data on molgramostim at CHEST 2025, focusing on efficacy by disease severity and related HRQoL metrics. These results could influence prescriber decisions for aPAP treatment. [1]
What’s the status of Invivyd’s COVID prevention program?
VYD2311, an antibody-based COVID prevention treatment, has received FDA IND clearance and is set for Phase 3 trials with top-line results expected in mid-2026. [2]
How does Merck’s acquisition of Verona Pharma impact COPD treatment?
Merck’s acquisition of Verona Pharma adds Ohtuvayre (ensifentrine) to their portfolio, a promising COPD maintenance therapy that strengthens their cardio-pulmonary offerings. [3]
What does the FDA approval of Jascayd mean for IPF treatment?
Jascayd (nerandomilast) offers a new therapy for IPF, the first in over a decade, showing potential for improved lung function but with limited survival benefits. [4]
What’s the update on Tvardi’s TTI-101 in IPF?
TTI-101 in IPF did not meet efficacy goals in Phase 2, with gastrointestinal side effects causing higher discontinuation rates. Further analysis will guide next steps. [6]
What is Leyden Labs doing with the €30M raise?
Leyden Labs will use the €30M from EIC Fund and Invest-NL to advance their pan-influenza nasal spray (PanFlu) and broader mucosal pipeline, enhancing global pandemic preparedness. [8]
Entities / Keywords
Savara; molgramostim; IMPALA-2; aPAP; CHEST 2025
Invivyd; VYD2311; COVID prevention; FDA IND
Merck; Verona Pharma; Ohtuvayre; COPD
Boehringer Ingelheim; Jascayd; nerandomilast; IPF
4DMT; 4D-710; Cystic Fibrosis; Phase 2
Tvardi Therapeutics; TTI-101; IPF; Phase 2
Chiesi; Triple Combination Inhaler; Asthma
Leyden Labs; PanFlu; EIC Fund; Invest-NL
References
https://www.merck.com/news/merck-completes-acquisition-of-verona-pharma/