Respiratory Video Recap—November 14, 2025

LucidQuest

4 days ago

This respiratory video recap spans late-stage trial launches, regulatory fast-track designations, trial resumptions, product rollouts, program discontinuations, and preclinical signals.

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Transcript

Welcome to this week’s Pulmonary & Respiratory Research Updates edition, covering the latest breakthroughs. Brought to you by LucidQuest.

Calluna Pharma has announced that its monoclonal antibody CAL101 has received FDA Orphan Drug Designation for the treatment of Idiopathic Pulmonary Fibrosis (IPF). CAL101, which targets S100A4, is currently being evaluated in the AURORA trial to assess its ability to prevent fibroblast activation in IPF patients. This designation could potentially expedite regulatory pathways and offer market exclusivity for CAL101.

The FDA has cleared Rein Therapeutics to resume its Phase 2 “RENEW” trial of LTI-03 in IPF. Enrollment will restart in late 2025 or early 2026. LTI-03, a peptide targeting fibrosis and promoting lung repair, offers hope for a new approach in treating IPF, a disease with limited treatment options.

Endeavor BioMedicines’ Taladegib (ENV-101), a Hedgehog pathway inhibitor, has received the EMA’s PRIME Designation for the treatment of IPF. The Phase 2a trial showed promising lung function improvements, accelerating the regulatory process for this potential breakthrough therapy.

Hanmi Pharma has signed a distribution agreement with Boehringer Ingelheim to bring COPD inhalers, including Spiriva Handihaler and Vahelva, to the Korean market. This partnership will increase access to vital COPD treatments in Korea, which has an estimated market value of 21.4 billion KRW.

Otsuka has initiated its Phase 3 QUANTUM-TB trial for quabodepistat, aimed at treating multidrug-resistant tuberculosis (MDR-TB). This trial will assess the efficacy of quabodepistat in both fluoroquinolone-sensitive and -resistant forms of MDR-TB, potentially offering a shorter and less toxic treatment option.

GSK Korea has launched the Nucala Auto Injector for patients with eosinophilic asthma, EGPA, and HES. This device, which allows for easy self-administration, could improve patient adherence and access to Nucala, a biologic therapy shown to be effective in treating these chronic eosinophilic diseases.

MannKind has announced the discontinuation of its Phase 3 ICoN-1 trial of nebulized clofazimine for non-tuberculous mycobacterial (NTM) lung disease due to lack of efficacy. Despite this, MannKind will continue to focus on the development of MNKD-102, a dry powder inhalation formulation of clofazimine, for NTM.

CalciMedica has published preclinical data supporting its CRAC channel inhibitor CM5480 as a potential therapy for pulmonary arterial hypertension (PAH). The data showed significant improvements in lung function and right ventricular hypertrophy, suggesting that CM5480 could offer a new approach to treating PAH.

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Why It Matters

IPF and pulmonary diseases: Advances in novel therapies like CAL101, LTI-03, and taladegib offer new hope for IPF, a disease with limited treatment options and high unmet need [1][2][3].
Global public health: New treatments for MDR-TB and COPD continue to emerge, expanding access and targeting resistant forms of these diseases [4][5].
Drug development: The CRAC channel inhibition mechanism in PAH and NTM lung disease illustrates how diverse approaches to fibrosis and vascular remodeling are gaining traction [7][8].

🗓️ Explore weekly details and sources

Week 31 October–6 November 2025
Week 7–13 November 2025

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

FAQ

What does PRIME Designation mean for Endeavor’s taladegib in IPF?

PRIME designation accelerates the development of taladegib, a promising therapy for IPF, potentially bringing it to market faster to address the significant unmet need in the disease [3].

What happened with MannKind’s ICoN-1 trial?

The ICoN-1 Phase 3 trial for nebulized clofazimine was discontinued after no sputum culture conversions were observed, though MannKind is still advancing its DPI formulation of the drug [7].

How will Otsuka’s quabodepistat address MDR-TB?

Otsuka’s Phase 3 QUANTUM-TB trial will evaluate quabodepistat regimens for MDR-TB, potentially offering a shorter and less toxic alternative to current treatments [5].

Entities / Keywords

Calluna Pharma; CAL101; IPF; FDA Orphan Drug Designation
Rein Therapeutics; LTI-03; FDA clinical hold; fibrosis
Endeavor BioMedicines; Taladegib; PRIME designation; EMA
Hanmi Pharma; Spiriva; Vahelva; COPD
Otsuka; Quabodepistat; MDR-TB; QUANTUM-TB
GSK; Nucala; Autoinjector; SEA; EGPA; HES
MannKind; MNKD-101; ICoN-1; NTM; MAC
CalciMedica; CM5480; Orai1; CRAC channel; Auxora; JCI Insight; PAH