Respiratory Video Recap—February 6, 2026

This biweekly Respiratory Video Recap highlights regulatory actions, clinical progress across mid- to late-stage trials, new data releases, and program updates across pulmonary diseases. Coverage spans approvals, NDA reviews, and study milestones.

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

🗓️ Explore weekly details and sources

• Week 23–26 January 2026
• Week 30 Januar –6 February 2026

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

Top Stories Covered in This Video

Chapters

0:00 Introduction
0:08 China approves Trelegy Ellipta for asthma, first single-inhaler triple therapy for both asthma and COPD
0:29 Ratutrelvir Phase 2 enrollment complete versus Paxlovid, TXM once-monthly influenza prophylaxis program advancing
1:03 Ohtuvayre (ensifentrine) NDA accepted in China for COPD maintenance
1:36 GRI-0621 in IPF shows Phase 2a RNA-seq modulation of fibrosis and repair pathways
2:05 MRX-5 IND cleared by FDA for Mycobacterium abscessus pulmonary disease Phase 2a
2:30 KT-621 first patient dosed in BREADTH Phase 2b eosinophilic asthma trial, FEV1 as primary endpoint
2:57 WVE-006 rights regained by Wave Life Sciences for AATD, FDA engagement on potential accelerated approval in 2026
3:26 CS1 PAH Expanded Access Program completes last-patient last-visit, initial learnings expected Q1 2026
3:58 How to reach us

Transcript

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

China has approved the asthma indication for Trelegy Ellipta, adding to its COPD label. This makes it the first single-inhaler triple therapy for both asthma and COPD in China, with the CAPTAIN study supporting the decision. Expect new competition that could influence pricing and formulary access.

Traws Pharma has completed enrollment in its open-label Phase 2 study of ratutrelvir versus PAXLOVID, with an additional arm for PAXLOVID-ineligible patients, totaling 90 participants. Ongoing analyses point to differentiated tolerability and symptom resolution signals, while a monthly tivoxavir marboxil tablet is advancing toward a 2026 influenza challenge study aiming for 28 days of coverage, with the primary endpoint not specified.

Nuance Pharma’s new drug application for Ohtuvayre, or ensifentrine, for COPD maintenance has been accepted in China following ENHANCE-CHINA. Prior access was available via Boao and the Greater Bay Area, and Macau has already approved it. Ensifentrine is a first-in-class dual PDE3 and PDE4 inhibitor that combines bronchodilation and non-steroidal anti-inflammatory activity, which could affect pricing and access dynamics.

GRI Bio reported Phase 2a RNA sequencing results for GRI-0621 in idiopathic pulmonary fibrosis showing favorable modulation of genes associated with lung injury, myofibroblast activation, extracellular matrix deposition, and epithelial repair compared with placebo. These signals align with earlier biomarker and functional findings, though the sample size was not stated.

MicuRx received FDA clearance of an investigational new drug application to begin a Phase 2a study of oral MRX-5 in Mycobacterium abscessus pulmonary disease. MRX-5 holds prior orphan designation, showed preclinical potency against resistant isolates, and demonstrated favorable early safety profiles.

Kymera Therapeutics dosed the first patient in BREADTH, a global, randomized, placebo-controlled, 12-week, dose-ranging Phase 2b trial in eosinophilic asthma. The primary endpoint is change in FEV1. KT-621 is an oral STAT6 degrader designed to impact IL-4 and IL-13 signaling that drives Type 2 inflammation.

Wave Life Sciences regained full rights to WVE-006 for alpha-1 antitrypsin deficiency from GSK and plans to engage with the FDA in 2026 to discuss potential accelerated approval. Additional RestorAATion-2 cohort readouts are expected, and the RNA editing AIMer is intended to address both lung and liver disease with subcutaneous dosing.

Cereno Scientific’s Expanded Access Program in pulmonary arterial hypertension completed the last-patient last-visit. Initial learnings are planned for the first quarter of 2026 to complement Phase 2a signals. CS1 is an oral histone deacetylase inhibitor with disease-modifying potential and holds orphan drug designation in the United States and European Union, along with FDA Fast Track.

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Why It Matters

• China respiratory market: Back-to-back NMPA actions on Trelegy and ensifentrine could reshape COPD and asthma maintenance options.
• Oral immunology in asthma: Kymera’s STAT6 degradation pushes biologics-like effects toward convenient oral dosing.
• Antiviral diversification: Traws advances non-ritonavir COVID therapy and once-monthly influenza prophylaxis strategy.
• Fibrosis repair biology: GRI-0621 adds multi-omic support for tissue repair mechanisms in IPF, a high-need setting.

🗓️ Explore weekly details and sources

• Week 23–29 January 2026
• Week 30 January–6 February 2026

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