Respiratory Today—October 17, 2025

Explore this week’s Respiratory highlights, including new developments, pipeline updates, and progress from biopharma leaders.

In Today’s Newsletter

💊 Sunshine Biopharma partners with University of Arizona for new protease inhibitors targeting SARS-CoV-2 [1] [US • 09 Oct 2025]

https://sunshinebiopharma.com/wp-content/uploads/2025/10/20251009_SBFM_Press-Release_Develops-New-Series-of-Non-Covalent-Protease-Inhibitors.pdf
Context: Novel oral PLpro inhibitors show efficacy in preclinical SARS-CoV-2 models.
Key Point: Significant step in antiviral drug development for emerging coronavirus variants.
Implication: Potential to reshape therapeutic approaches against future viral outbreaks.

🌬️ Rein Therapeutics gains European regulatory approval for Phase 2 trial of LTI-03 in IPF [2] [EU • 09 Oct 2025]

https://ir.reintx.com/news-releases/news-release-details/rein-therapeutics-receives-european-regulatory-approval-initiate
Context: EMA approval to initiate the RENEW trial of LTI-03 for idiopathic pulmonary fibrosis.
Key Point: LTI-03 targets fibrosis reduction and lung regeneration.
Implication: Rein’s trial could set a new standard for treating fibrotic lung diseases.

🇨🇳 Changxi Pharmaceutical collaborates with Huadong Pharmaceutical for CXG87 asthma treatment [3] [China• 09 Oct 2025]

https://www.chancepharmaceuticals.com/newsinfo/10750000.html
Context: Exclusive commercialization deal for CXG87 in mainland China, Phase III trials complete.
Key Point: Modified budesonide/formoterol inhaler shows promise for asthma patients with limited inspiratory airflow.
Implication: Major expansion opportunity for Changxi in the Chinese asthma market.

🫁 Boehringer Ingelheim’s JASCAYD® (nerandomilast) approved for IPF [4] [US • 09 Oct 2025]

https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-jascayd-nerandomilast-first-new-treatment-ipf-over-decade
Context: First new oral therapy for IPF in over a decade, improving lung function in clinical trials.
Key Point: Demonstrated efficacy in slowing Forced Vital Capacity (FVC) decline.
Implication: A new option for IPF patients in need of better disease management.

💰 Expedition Therapeutics raises $165M to push EXPD-101 into Phase 2 for COPD [5] [US • 09 Oct 2025]

https://expeditiontx.com/news/expedition-therapeutics-raises-165-million-in-oversubscribed-series-a-financing-to-advance-next-generation-dpp1-inhibitor-for-copd/
Context: Funding will support global Phase 2 study of DPP1 inhibitor EXPD-101.
Key Point: Targeting neutrophil-driven inflammation in COPD with first-in-class potential.
Implication: Strong investor interest signals optimism around COPD therapies targeting inflammatory pathways.

🔬 Oticara’s intranasal steroid cream shows promise in Phase 2 CRS trial [6] [13 Oct 2025]

https://www.hcplive.com/view/intranasal-steroid-cream-post-surgery-improves-crs-symptoms-phase-2-trial
Context: Steroid cream improves symptoms of post-surgical chronic rhinosinusitis.
Key Point: In-office application provides durable symptom relief with minimal adverse effects.
Implication: Potential to revolutionize post-surgical CRS management in ENT practices.

🧪 Tvardi Therapeutics’ TTI-101 shows limited efficacy in Phase 2 IPF trial [7] [US • 13 Oct 2025]

https://ir.tvarditherapeutics.com/news-releases/news-release-details/tvardi-therapeutics-provides-update-preliminary-data-phase-2
Context: Preliminary Phase 2 data show no significant benefit of TTI-101 over placebo in IPF patients.
Key Point: Gastrointestinal side effects led to high discontinuation rates in treatment arms.
Implication: Tvardi may reconsider development strategy for TTI-101 in IPF, seeking new approaches.

🌬️ 4D Molecular Therapeutics advances 4D-710 with new Cystic Fibrosis Foundation funding [8] [US • 13 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/13/3165500/0/en/4DMT-Advances-4D-710-to-Phase-2-with-Additional-Funding-and-Support-from-the-Cystic-Fibrosis-Foundation.html
Context: Additional funding to support Phase 2 clinical trial for cystic fibrosis treatment. Key Point: 4D-710 shows potential as a durable, redosable genetic therapy for CF lung disease.
Implication: Potential for 4D-710 to become a foundational CF therapy with long-term benefits.

💉 Precigen’s PAPZIMEOS™ shows durable responses in RRP patients [9] [US • 13 Oct 2025]

https://investors.precigen.com/news-releases/news-release-details/precigen-announces-long-term-follow-results-highlighting-ongoing
Context: Long-term follow-up data show 83% of complete responders maintain remission for up to 36 months.
Key Point: Significant reduction in surgeries and no new safety events observed.
Implication: PAPZIMEOS may set a new standard in RRP treatment, offering sustained benefits and fewer surgeries.

🫁 Chiesi’s triple combination inhaler for asthma receives FDA acceptance for NDA [10] [US • 13 Oct 2025]

https://www.chiesiusa.com/news-details.php?guid=https://www.globenewswire.com/news-release/2025/10/15/3167051/0/en/Chiesi-Announces-FDA-Acceptance-of-New-Drug-Application-for-its-Triple-Combination-Inhaler-for-the-Maintenance-Treatment-of-Asthma.html
Context: Triple inhaler (beclomethasone/formoterol/glycopyrrolate) shows positive results for uncontrolled asthma.
Key Point: Inhaler is already approved in over 50 countries and now seeks US approval.
Implication: Could help address the unmet needs of asthma patients in the US, offering a more convenient treatment option.

Why it matters

SARS-CoV-2 antiviral treatments: Sunshine Biopharma’s PLpro inhibitors could play a crucial role in fighting future coronavirus variants, expanding antiviral treatment options.[1]
IPF treatment: Rein Therapeutics’ LTI-03 could redefine IPF care by reducing fibrosis and promoting lung regeneration.[2]
Asthma therapy in China: The Changxi-Huadong partnership brings CXG87 to China, improving asthma treatment for patients with limited inspiratory flow.[3]
New IPF therapy: JASCAYD® (nerandomilast) offers a new option for IPF, addressing both fibrosis and immune modulation.[4]
COPD innovation: Expedition Therapeutics’ EXPD-101 targets neutrophil-driven inflammation, potentially transforming COPD treatment.[5]
CRS treatment: Oticara’s steroid cream offers rapid, durable relief for post-surgical CRS, reducing the need for repeated surgeries.[6]
RRP breakthrough: Precigen’s PAPZIMEOS™ offers a new, long-lasting treatment for recurrent respiratory papillomatosis, reducing surgeries.[9]
Cystic fibrosis: 4D-710 has the potential to become a transformative genetic treatment for CF.[8]
Asthma management: Chiesi’s triple combination inhaler could address unmet needs in asthma care in the U.S.[10]

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FAQ

What makes Sunshine Biopharma’s PLpro inhibitors important?

Sunshine Biopharma’s PLpro inhibitors are designed to target a key enzyme involved in SARS-CoV-2 replication. By inhibiting this protease, these compounds have the potential to slow down viral replication, reducing the severity and spread of the virus, particularly important in the face of emerging variants.

How could LTI-03 change the treatment of IPF?

LTI-03 from Rein Therapeutics is a first-in-class therapy that aims to both inhibit fibrosis and promote lung tissue regeneration. This dual approach could redefine how IPF is treated, improving patient outcomes and potentially reducing the burden of the disease on patients and the healthcare system.

What is the significance of the CXG87 partnership?

The collaboration between Changxi Pharmaceutical and Huadong Pharmaceutical aims to bring CXG87, an innovative asthma therapy, to the Chinese market. CXG87 addresses the challenges faced by patients with asthma who have limited inspiratory airflow, improving the delivery of the medication and enhancing treatment efficacy.

Why is the approval of JASCAYD for IPF important?

JASCAYD (nerandomilast) is the first new oral treatment for IPF in over a decade, offering a much-needed option for patients. Its approval highlights progress in managing the disease, offering a new mechanism of action that could slow the decline in lung function and improve overall patient quality of life.

What is the potential of EXPD-101 in COPD treatment?

EXPD-101, developed by Expedition Therapeutics, is a first-in-class DPP1 inhibitor targeting neutrophil-driven inflammation, a key factor in COPD. The funding will enable the next stages of its clinical development, potentially offering a new treatment option for patients, especially those with non-type 2 COPD, which remains difficult to treat.

How does Oticara’s intranasal steroid cream work for CRS?

Oticara’s intranasal steroid cream is applied in-office, providing patients with a single-dose treatment for post-surgical chronic rhinosinusitis (CRS). The treatment has shown promising results in Phase 2 trials, improving symptoms such as nasal congestion and drainage with minimal adverse effects.

What does Precigen’s PAPZIMEOS™ approval mean for RRP patients?

Precigen’s PAPZIMEOS™ offers a groundbreaking treatment for recurrent respiratory papillomatosis (RRP), a rare disease caused by HPV infection. The therapy has shown durable responses, significantly reducing the need for repeated surgeries, offering a much-needed improvement in the quality of life for RRP patients.

What is the significance of 4D-710 for cystic fibrosis?

4D-710, a genetic medicine from 4D Molecular Therapeutics, represents a novel approach to treating cystic fibrosis by directly addressing the root cause of the disease. This could dramatically improve lung function and overall health for CF patients, marking a significant step forward in CF therapy.

How could Chiesi’s triple combination inhaler help asthma patients?

Chiesi’s triple combination inhaler combines an inhaled corticosteroid, a long-acting beta-agonist, and an anticholinergic in a single device. This inhaler offers a more convenient treatment option for asthma patients, particularly those whose symptoms are difficult to control with current therapies.