This week’s respiratory update highlights continued momentum across pulmonary and respiratory diseases, with new clinical signals in idiopathic pulmonary fibrosis, cystic fibrosis, COPD, and severe asthma, alongside gene therapy and in vivo editing advances. Developments span early- and mid-stage trials, financings, and regulatory clearances that may shape future treatment landscapes.
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🧪 Tvardi TTI-101 further REVERT IPF analysis [1] [08 Jan 2026]
Context: Randomized Phase 2 IPF trial; 12-week subset analysis of 40 patients after exclusions.
Key point: Greater decline in HRCT fibrosis score with TTI-101 vs placebo, IL-6 reductions aligned with STAT3 inhibition, and more patients with FVC increases at 12 weeks.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 GRI-0621 Phase 2a IPF immune-profiling update [2] [08 Jan 2026]
Context: 12-week, randomized, placebo-controlled study in 35 IPF subjects, BAL sub-study (n=8).
Key point: iNKT inhibition with shift toward IFN-γ and reduced IL-4/IL-13/IL-17A/IL-22/TGF-β in BAL and PBMC; prior readout met safety and showed supportive clinical signals.
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.
🌬️ Agomab AGMB-447 Phase 1 interim + IPF cohort start [3] [08 Jan 2026]
https://www.agomab.com/wp-content/uploads/2026/01/20260108_AGMB-447-Topline-Ph1-in-HV_FINAL.pdf
Context: SAD/MAD healthy-volunteer study of inhaled ALK5 inhibitor; Part C dosing initiated in IPF.
Key point: No safety signals, lung-restricted PK, dose-dependent pSMAD3 reduction in BAL cells; plans for Phase 2 in 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Krystal KB407 CF gene therapy CORAL-1 update [4] [08 Jan 2026]
Context: Phase 1, open-label, high-dose cohort; inhaled redosable vector in CF patients.
Key point: Wild-type CFTR delivery and expression confirmed, airway transduction ~29–42% across biopsies; generally well tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.
🧿 Clarametyx CMTX-101 Phase 1b/2a in CF [5] [09 Jan 2026]
https://clarametyx.com/clarametyx-biosciences-announces-positive-topline-data/
Context: Randomized, double-blind, placebo-controlled single-dose IV in 42 pwCF on SOC.
Key point: Met safety endpoint, reduced neutrophil elastase and other inflammatory markers, lowered P. aeruginosa CFU, preserved FEV1.
Implication: May influence prescriber choice and payer reviews pending full data.
💨 AirNexis launches with $200M, licenses AN01 for COPD [6] [09 Jan 2026]
Context: Newco backed by Frazier and others; ex-China rights from Haisco.
Key point: Dual PDE3/4 inhibitor AN01 in Phase 2 in China, two inhaled dosage forms; proceeds fund global development.
Implication: Signals pipeline investment and modality expansion.
🌪️ Kinaset raises $103M Series B for frevecitinib [7] [10 Jan 2026]
Context: Financing led by RA Capital and Forge.
Key point: Funds Phase 2 dose-ranging in severe asthma for inhaled pan-JAK inhibitor with lung-targeted exposure.
Implication: Signals pipeline investment and modality expansion.
🧫 AN2 epetraborole IIT cleared in M. abscessus [8] [12 Jan 2026]
Context: FDA cleared OHSU IND for 90-patient randomized, placebo-controlled multicenter IIT.
Key point: Targets treatment-naive M. abscessus lung disease to assess safety, efficacy, PK of oral epetraborole.
Implication: May influence prescriber choice and payer reviews pending full data.
🧷 Tessera IND cleared for TSRA-196 in AATD [9] [12 Jan 2026]
Context: First IND for in vivo TPRT-based genome editing; HREC approval in Australia.
Key point: Phase 1/2 open-label study to assess single IV dose in adults with AATD, tracking safety and AAT biomarkers.
Implication: Signals pipeline investment and modality expansion.
🌱 Boehringer starts Phase IIa for IL-11 inhibitor in IPF [10] [13 Jan 2026]
Context: BI 765423, anti-IL-11 mAb, first-in-class mechanism entering IPF efficacy testing.
Key point: Phase IIa to evaluate lung function outcomes following favorable Phase I safety.
Implication: May influence prescriber choice and payer reviews pending full data.
🦠 Traws: TXM IND for influenza; ratutrelvir COVID-19 update [11] [13 Jan 2026]
Context: TXM is single-dose CEN inhibitor; ratutrelvir is ritonavir-free 3CL protease inhibitor.
Key point: TXM IND filed, positioning for BARDA consideration; interim Phase 2 shows ratutrelvir with fewer AEs, no rebounds, faster symptom resolution vs Paxlovid in small dataset.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- IPF pipeline momentum spans STAT3, IL-11, ALK5/TGFβ, and iNKT axes, indicating diversified shots on goal.
- CF therapeutics advance beyond modulators, with gene delivery and anti-biofilm strategies showing early promise.
- Respiratory infection space remains active, with oral antivirals targeting influenza and COVID-19 usability gaps.
- Financing for inhaled anti-inflammatories underscores investor interest in lung-restricted mechanisms and broader asthma/COPD coverage.
- Multiple regulatory clearances set up 2026 as a data-rich year across fibrotic and infectious lung indications.
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FAQ
What did Tvardi’s REVERT IPF analysis newly show for TTI-101?
Further 12-week analysis suggested greater HRCT fibrosis score improvement and IL-6 reduction vs placebo, with more patients showing FVC increases, though the overall study previously did not meet goals [1].
How does GRI-0621 aim to modify IPF biology?
GRI-0621 targets iNKT pathways. New flow cytometry data showed a shift toward anti-fibrotic cytokines and reduced TGF-β in BAL and PBMC, supporting earlier clinical signals from the 12-week randomized study [2].
What differentiates Agomab’s AGMB-447?
It is an inhaled, lung-restricted ALK5 (TGFβR1) inhibitor showing dose-dependent target engagement in BAL cells, low systemic exposure, and clean safety in healthy volunteers; IPF patient dosing has started [3].
What is novel about Krystal’s KB407 readout?
In CF patients, inhaled KB407 achieved broad airway transduction and confirmed expression of wild-type CFTR protein in relevant airway cells at the highest dose cohort, with tolerability consistent with earlier cohorts [4].
What signals did Clarametyx report in CF?
CMTX-101 met safety goals and showed reductions in neutrophil elastase and other inflammatory biomarkers, decreased P. aeruginosa burden, and preservation of FEV1 vs SOC in a Phase 1b/2a study [5].
Which programs just cleared key regulatory gates?
AN2’s epetraborole IIT in M. abscessus (FDA IND clearance) [8] and Tessera’s TSRA-196 in AATD (FDA IND and Australian HREC approval) [9] both cleared to initiate clinical evaluation.
Entities / Keywords
Idiopathic Pulmonary Fibrosis (IPF); Cystic Fibrosis (CF); Bronchiectasis; COPD; Severe asthma; M. abscessus; AATD; STAT3; IL-11; TGFβ/ALK5; iNKT; CFTR; Biofilm; PDE3/4; JAK inhibitors; Gene Writing (TPRT); Antivirals (CEN, 3CL).
References
- https://ir.tvarditherapeutics.com/news-releases/news-release-details/tvardi-therapeutics-announces-further-phase-2-revert-ipf-data
- https://gribio.com/gri-bio-announces-additional-positive-data-from-phase-2a-study-in-idiopathic-pulmonary-fibrosis-strengthening-clinical-proof-of-concept-for-gri-0621/
- https://www.agomab.com/wp-content/uploads/2026/01/20260108_AGMB-447-Topline-Ph1-in-HV_FINAL.pdf
- https://www.globenewswire.com/news-release/2026/01/08/3215774/0/en/Krystal-Biotech-Announces-Positive-Interim-Clinical-Update-from-KB407-Phase-1-CORAL-1-Study-with-Confirmation-of-Wild-Type-CFTR-Delivery-to-the-Lungs-of-Patients-with-Cystic-Fibros.html
- https://clarametyx.com/clarametyx-biosciences-announces-positive-topline-data/
- https://www.biospace.com/press-releases/airnexis-therapeutics-launches-with-200m-series-a-to-advance-phase-2-dual-pde3-4-inhibitor-an01-for-chronic-obstructive-pulmonary-disease-copd
- https://www.kinasettherapeutics.com/kinaset-therapeutics-announces-103-million-oversubscribed-series-b-financing
- https://investor.an2therapeutics.com/news-releases/news-release-details/an2-therapeutics-announces-fda-clearance-proceed-90-patient
- https://www.tesseratherapeutics.com/news/tessera-therapeutics-announces-fda-clearance-of-ind-application-for-its-lead-in-vivo-gene-editing-program-tsra-196-for-aatd
- https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/new-trial-explores-advancements-ipf-treatment
- https://www.trawspharma.com/press-release-single?id=traws-pharma-files-tivoxavir-marboxil-investigational-new-drug-ind-application-for-influenza-therapy-and-provides-updated-results-from-the-ongoing-clinical-study-of-ratutrelvir-in-paxlovid-r-eligible-and-ineligible-covid-19-patients