Respiratory Today—March 20, 2026

This week’s Respiratory, Research update highlights regulatory progress, mid-stage clinical execution, regional approvals, platform expansion, and advancing development across infectious, inflammatory, fibrotic, and rare pulmonary diseases.

In Today’s Newsletter

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🫁 Alpibectir-ethionamide enters Phase 2b in pulmonary TB [1] [EU • 12 Mar 2026]

https://ir.bioversys.com/news/bioversys-announces-first-patient-dosed-in-phase-2b-clinical-trial-of-alpe-in-pulmonary-tuberculosis/9715421b-5c9f-4f78-9b71-2c3bcc605796
Context: The study is running in six African countries within UNITE4TB; AlpE is given for two months with RZE, then patients continue RH for 18 weeks.
Key point: Alpibectir-ethionamide, AlpE (BioVersys; GSK) reached first-patient-dosed status in a Phase 2b trial in adults with drug-susceptible pulmonary tuberculosis.
Implication: May influence prescriber choice and payer reviews pending full data.

🌼 INI-2004 advances in allergic rhinitis Phase 2 study [2] [US • 12 Mar 2026]

https://inimmune.com/inimmune-completes-enrollment-and-doses-first-patient-in-phase-2-chamber-trial-of-ini-2004-for-allergic-rhinitis/
Context: The company said the study is evaluating safety, tolerability, and efficacy, with topline data expected in June 2026.
Key point: INI-2004 (Inimmune; TLR4-targeting immunotherapy) completed enrollment and dosed the first patient in a randomized, placebo-controlled Phase 2 allergen challenge chamber trial in allergic rhinitis.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Baseimmune expands into fibrosis with an IPF lead program [3] [UK • 12 Mar 2026]

https://www.baseimmune.co.uk/press-release-baseimmune-announces-strategic-expansion-into-fibrosis.html
Context: The company said preclinical IPF work is advancing toward proof-of-concept efficacy readouts in 2026 and 2027, and it named a fibrosis-focused scientific advisory board.
Key point: Baseimmune launched a fibrosis-focused pipeline, initially centered on idiopathic pulmonary fibrosis, IPF, using a multi-pathway immunotherapy strategy.
Implication: Signals pipeline investment and modality expansion.

🧪 YOLT-202 wins FDA clearance for Phase 2/3 in AATD [4] [US • 13 Mar 2026]

https://www.yoltx.com/news/press-release/110
Context: YolTech said two patients in an ongoing first-in-human investigator-initiated trial had completed dosing, with rapid increases in AAT levels reported after treatment.
Key point: YOLT-202 (YolTech Therapeutics; in vivo base-editing therapy) received FDA IND clearance to start a Phase 2/3 study in alpha-1 antitrypsin deficiency, AATD.
Implication: May influence prescriber choice and payer reviews pending full data.

💨 Ohtuvayre approved in Hong Kong for COPD maintenance [5] [Hong Kong SAR • 12 Mar 2026]

https://www.prnewswire.com/apac/news-releases/nuance-pharma-announces-approval-of-ohtuvayre-ensifentrine-in-hong-kong-sar-china-302712086.html
Context: Nuance said the approval used the Global Phase 3 ENHANCE trials and the completed ENHANCE-CHINA trial; the company also noted prior Macau approval and mainland China NDA review acceptance.
Key point: Ohtuvayre, ensifentrine (Nuance Pharma; licensed from Verona Pharma for Greater China) was approved in Hong Kong SAR for maintenance treatment of COPD in adults.
Implication: Introduces competition that may affect pricing and formulary access.

🍽️ EP-104GI posts six-month symptom data in EoE [6] [Canada • 17 Mar 2026]

https://investors.eupraxiapharma.com/news-releases/news-release-details/eupraxia-pharmaceuticals-reports-six-month-symptom-data-highest
Context: Eupraxia reported 31 patients treated across the Phase 1b/2a study, more than 220 patient-months of follow-up, no serious adverse events, and no reported oropharyngeal candidiasis.
Key point: EP-104GI (Eupraxia Pharmaceuticals) showed a mean 4-point SDI reduction at 24 weeks in the highest-dose cohort (n=3) of the Phase 1b/2a RESOLVE trial in eosinophilic esophagitis, EoE.
Implication: May influence prescriber choice and payer reviews pending full data.

❤️ CS014 cleared for FDA-aligned PK work ahead of PH-ILD Phase II [7] [EU • 17 Mar 2026]

https://cerenoscientific.com/press-single/?releaseIdentifier=F135CAC51B1103DE
Context: The 14-volunteer crossover study will compare steady-state PK after seven days of oral dosing versus valproic acid; results are expected in mid-2026.
Key point: CS014 (Cereno Scientific; precision deuterated HDAC inhibitor) received Swedish regulatory approval to start an FDA-aligned Phase I pharmacokinetic study supporting Phase II development in PH-ILD.
Implication: Signals pipeline investment and modality expansion.

👶 SK bioscience wins RIGHT Foundation backing for RSV antibody RSM01 [8] [South Korea • 18 Mar 2026]

https://www.skbioscience.com/en/news/news_01_01?mode=2&id=342&page=1
Context: SK bioscience said it licensed RSM01 from Gates Medical Research Institute earlier in March and will lead Phase 1b, process development, and commercialization.
Key point: RSM01 (SK bioscience; RSV preventive monoclonal antibody) secured RIGHT Foundation funding to support early clinical development and accelerate a Phase 1b trial in infants.
Implication: Access programs may expand screening, initiation, and follow-up at scale.

Why it matters

Tuberculosis, COPD, allergic disease, EoE, PH-ILD, AATD, IPF, and RSV prevention all saw tangible development milestones in one week, spanning dosing, enrollment, regulatory clearance, approval, and funding.
Several programs moved from early validation toward later-stage execution, notably AlpE in TB [1], YOLT-202 in AATD [4], and EP-104GI in EoE [6].Regulatory path-shaping is a clear theme, with FDA-linked decisions affecting YOLT-202 [4] and CS014 [7], and regional access expanding for Ohtuvayre in Greater China [5].
Platform stories remain prominent, including Baseimmune’s multi-pathway fibrosis strategy [3], Inimmune’s allergen-agnostic approach [2], and SK bioscience’s global-access framing for RSM01 [8].
Source language is optimistic in several releases, so the strongest near-term readouts to watch are named toplines and PK data expected in 2026 [1][2][6][7].

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FAQ

What changed this week for AlpE in tuberculosis?

BioVersys said Alpibectir-ethionamide, AlpE, dosed its first patient in a Phase 2b pulmonary TB study under UNITE4TB. The company also said Phase 2b results are expected by the end of 2027 and a TB meningitis Phase 2 study is planned for H1 2026. [1]

What is notable about INI-2004 in allergic rhinitis?

Inimmune said INI-2004 completed enrollment and dosed the first patient in a randomized, placebo-controlled Phase 2 chamber study. The company positioned it as an allergen-agnostic, potentially disease-modifying immunotherapy, with topline data expected in June 2026. [2]

Why does FDA clearance for YOLT-202 matter?

The clearance allows YolTech to begin a Phase 2/3 study in adults with AATD. The company also cited early first-in-human investigator-initiated data showing AAT increases after dosing, but those results remain early and from a very small treated set. [4]

What did Eupraxia report for EP-104GI in RESOLVE?

Eupraxia reported 24-week symptom data from the highest-dose Phase 1b/2a cohort, with a mean 4-point SDI reduction in three patients. The company also said no serious adverse events had been reported across 31 treated patients and over 220 patient-months of follow-up. [6]

What is the role of the new CS014 pharmacokinetic study?

Cereno said the FDA-aligned Phase I PK study is designed to compare CS014 with valproic acid and could support a more streamlined path toward Phase IIb in PH-ILD. The company said successful data may remove the need for additional safety studies and a Phase IIa trial. [7]

What is RSM01 and how is SK bioscience positioning it?

RSM01 is an RSV preventive monoclonal antibody that SK bioscience licensed from Gates MRI. SK bioscience said RIGHT Foundation funding will help accelerate Phase 1b in infants and support a dual commercialization strategy that includes broader global supply. [8]

Entities / Keywords

Alpibectir-ethionamide (AlpE), alpibectir, BVL-GSK098, BioVersys, GSK, UNITE4TB, pulmonary tuberculosis, TB meningitis
INI-2004, Inimmune, allergic rhinitis, allergen challenge chamber, TLR4, allergen-agnostic immunotherapy
Baseimmune, idiopathic pulmonary fibrosis, IPF, fibrosis, computational protein design, multi-pathway immunotherapy
YOLT-202, YolTech Therapeutics, alpha-1 antitrypsin deficiency, AATD, SERPINA1, in vivo base editing
Ohtuvayre, ensifentrine, Nuance Pharma, Verona Pharma, MSD, COPD, ENHANCE, ENHANCE-CHINA
EP-104GI, Eupraxia Pharmaceuticals, RESOLVE, eosinophilic esophagitis, EoE, SDI, Diffusphere
CS014, Cereno Scientific, PH-ILD, pulmonary hypertension associated with interstitial lung disease, HDAC inhibitor, PK study
RSM01, SK bioscience, RIGHT Foundation, Gates Medical Research Institute, RSV preventive antibody, monoclonal antibody