Respiratory Today—February 6, 2026

LucidQuest

3 hours ago

This week’s Respiratory update covers regulatory engagement plans, clinical trial initiations, data readouts, and strategic partnerships across inflammatory, infectious, and rare lung diseases.

In Today’s Newsletter

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💊 MicuRx IND cleared for MRX-5 Phase 2a in M. abscessus [1] [29 Jan 2026]

http://www.micurx.com/2755.html
Context: FDA cleared IND for MRX-5, an oral antibacterial targeting non-tuberculous mycobacteria.
Key point: MicuRx to initiate a multicenter Phase 2a in M. abscessus pulmonary disease, following preclinical activity and favorable PK/safety.
Implication: May influence prescriber choice and payer reviews pending full data.

👃 ENA starts Phase II POSITS of INNA-051 nasal spray [2] [29 Jan 2026]

https://enarespiratory.com/ena-respiratory-announces-dosing-of-first-participants-in-phase-ii-study-of-inna-051-nasal-spray-designed-to-protect-against-symptomatic-viral-respiratory-infections/
Context: Community study evaluates weekly, virus-agnostic TLR2/6 agonist in crowded-exposure settings.
Key point: Up to 1,100 participants across two phases, assessing safety, tolerability, and impact on symptomatic viral infections.
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

🌬️ Kymera doses first patient in KT-621 asthma Phase 2b [3] [29 Jan 2026]

https://investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-first-patient-dosed-breadth-phase
Context: BREADTH is a global, randomized, double-blind, placebo-controlled, 12-week study in moderate to severe eosinophilic asthma (n≈264).
Key point: Primary endpoint is change from baseline in FEV1, with dose-ranging across three oral KT-621 regimens.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 Lupin partners with TB Alliance on telacebec [4] [02 Feb 2026]

https://www.lupin.com/lupin-and-tb-alliance-join-forces-to-advance-telacebec-for-the-treatment-of-tuberculosis-and-other-mycobacterial-diseases/
Context: Collaboration to advance clinical development and commercialization for TB and other mycobacterial diseases.
Key point: TB Alliance leads development, Lupin contributes manufacturing, regulatory, and global access capabilities.
Implication: Signals pipeline investment and modality expansion.

🧬 Wave regains WVE-006 rights, eyes accelerated path in AATD [5] [02 Feb 2026]

https://ir.wavelifesciences.com/news-releases/news-release-details/wave-life-sciences-announces-plans-accelerate-regulatory
Context: Wave assumes full control from GSK for RNA editing candidate WVE-006 in alpha-1 antitrypsin deficiency.
Key point: Plans FDA engagement on a potential accelerated approval pathway, with further RestorAATion-2 data expected in 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

🔬 MiNK presents iNKT depletion data in advanced IPF [6] [03 Feb 2026]

https://investor.minktherapeutics.com/news-releases/news-release-details/mink-therapeutics-presents-new-data-allo-inkt-cell-therapy
Context: Keystone Symposia poster shows significant iNKT cell depletion in lung-associated lymph nodes from end-stage IPF.
Key point: Findings extend iNKT platform rationale from acute lung injury to chronic fibrotic lung disease.
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

🗂️ aTyr sets FDA Type C meeting on efzofitimod in sarcoidosis [7] [03 Feb 2026]

https://investors.atyrpharma.com/news-releases/news-release-details/atyr-pharma-announces-scheduling-fda-type-c-meeting-discuss
Context: Meeting to review Phase 3 EFZO-FIT results and determine path forward in pulmonary sarcoidosis.
Key point: EFZO-FIT did not meet the primary endpoint, but multiple patient-reported measures favored efzofitimod with maintained lung function and tolerability.
Implication: May influence prescriber choice and payer reviews pending full data.

🫀 Cereno CS1 EAP completes last patient last visit in PAH [8] [03 Feb 2026]

https://cerenoscientific.com/press-single/?releaseIdentifier=635FC9D63E6B8A0C
Context: 12-month expanded access program for 10 post-Phase IIa PAH patients concluded active follow-up.
Key point: Initial learnings targeted for Q1 2026, with additional analyses planned in Q2 to complement Phase IIa signals.
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

🫁 Cereno broadens CS014 focus to PH-ILD, plans Phase II [9] [04 Feb 2026]

https://cerenoscientific.com/press-single/?releaseIdentifier=9A556543B80FFFF1
Context: CS014, an oral HDAC inhibitor with favorable Phase I safety, shifts to pulmonary hypertension associated with ILD.
Key point: Strategy aims for a more clinically relevant Phase II program in a high-need population, with initiation planned Q1 2027.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Oral MRX-5 and KT-621 represent convenient modalities that, if effective, could expand options in difficult lung infections and Type 2 inflammation [1][3].
INNA-051’s community study addresses broad, real-world viral exposure where vaccines or antivirals have limits [2].
Telacebec collaboration targets high-burden mycobacterial diseases with global access in mind [4].
WVE-006’s potential accelerated path could bring a first-in-class RNA editing therapy to AATD across lung and liver disease [5].
Translational and access data from MiNK and Cereno may de-risk future interventional trials in IPF and PAH/PH-ILD [6][8][9].

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FAQ

What is MRX-5 and what will the Phase 2a test?

MRX-5 is an oral antibacterial for non-tuberculous mycobacteria. The cleared Phase 2a will evaluate safety and efficacy in M. abscessus pulmonary disease at U.S. sites [1].

How is INNA-051 intended to be used in the POSITS study?

It is a once-weekly, dry powder nasal spray priming innate defenses via TLR2/6. POSITS assesses safety and impact on symptomatic viral infections in high-exposure young adults, with up to 1,100 participants across two phases [2].

What is the primary endpoint in Kymera’s BREADTH asthma trial?

Change from baseline in FEV1 over 12 weeks, with three oral dose arms of KT-621 in moderate to severe eosinophilic asthma (n≈264) [3].

What does the Lupin–TB Alliance deal cover for telacebec?

TB Alliance leads development. Lupin supports manufacturing, regulatory, and supply to enable global access across TB and other mycobacterial diseases [4].

Why did Wave regain WVE-006 and what is the next step?

Wave assumes full control from GSK to accelerate registrational strategy in AATD and plans to engage FDA regarding a potential accelerated approval pathway, while additional clinical data readouts are expected in 2026 [5].

Did aTyr’s Phase 3 meet its primary endpoint? What is happening next?

EFZO-FIT did not meet the primary endpoint but showed benefits on several patient-reported outcomes and maintained lung function. An FDA Type C meeting is scheduled for mid-April 2026 to determine next steps [7]

Entities / Keywords

MicuRx, MRX-5, Mycobacterium abscessus, non-tuberculous mycobacteria, ENA Respiratory, INNA-051, TLR2/6, Kymera Therapeutics, KT-621, STAT6 degrader, eosinophilic asthma, Lupin, TB Alliance, telacebec, Wave Life Sciences, WVE-006, alpha-1 antitrypsin deficiency, MiNK Therapeutics, iNKT cells, idiopathic pulmonary fibrosis, aTyr Pharma, efzofitimod, pulmonary sarcoidosis, Cereno Scientific, CS1, pulmonary arterial hypertension, CS014, PH-ILD.