Kither Biotech successfully completes Phase 1 clinical trial of KIT2014, a novel inhaled peptide therapy for respiratory diseases

• First-in-human Phase 1 study in 56 healthy participants demonstrated KIT2014’s safety and tolerability
• KIT2014 is being developed as an inhalation therapy for respiratory diseases including chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis (NCFB) and cystic fibrosis (CF)
• KIT2014’s unique mode of action improves respiratory symptoms by promoting bronchodilation and reducing lung inflammation
  

TURIN, Italy, June 19, 2026 (GLOBE NEWSWIRE) -- Kither Biotech Pty Ltd and Kither Biotech srl, a clinical-stage biopharmaceutical group of companies developing innovative therapies for respiratory diseases, today announced the successful completion of their Phase 1 clinical study of KIT2014 in healthy participants.

“We are pleased to report the successful completion of this first-in-human Phase 1 study with KIT2014, a significant milestone for Kither Biotech,” said Dr. Dimitrios Goundis, CEO of Kither Biotech. “The study results demonstrate KIT2014’s favourable safety and tolerability profile. The unique ability of KIT2014 to increase cAMP in different airway cell types offers the potential for multiple therapeutic benefits, including bronchodilation and anti-inflammatory effects. We look forward to advancing the clinical development of KIT2014, to assess its therapeutic potential in patients with respiratory diseases including COPD, NCFB and CF.”

“We are delighted that this first-in-human study has successfully demonstrated that inhaled KIT2014 was safe and well tolerated across all dose levels evaluated, with no measurable systemic exposure,” said Anita van der Meer, Director of Kither Biotech Pty Ltd. “These findings support the continued clinical development of KIT2014 and provide a strong foundation for advancing into patient studies in COPD, where we aim to further explore its unique multimodal mechanism of action and potential to address important unmet medical needs.”

KIT2014 is a novel cell-permeable peptide delivered via inhalation, which is designed to address multiple pathological pathways common to a number of major respiratory diseases. The drug, which consists of 42 amino acids, acts to promote bronchodilation and reduce lung inflammation. It does this through balanced dual inhibition of the enzymes phosphodiesterase 3 and 4 (PDE3/4), which increases local concentrations of the key signalling molecule cAMP (cyclic adenosine monophosphate). KIT2014 is being developed for a number of respiratory diseases including COPD, NCFB and CF.

Key findings of the Phase 1 study were that:

• Treatment with KIT2014 at doses ranging from 0.1 mg to 2 mg daily for up to 7 days was safe and well tolerated.
• Blood plasma levels of KIT2014 were below the limit of detection at all dose levels, both in the single ascending dose (SAD) and multiple ascending dose (MAD) parts of the study, indicating direct administration to the lungs results in very low systemic exposure.

This Phase 1 clinical trial was a double-blind, randomised, placebo-controlled, two-part dose escalation study (single ascending dose and multiple ascending dose), conducted in 56 healthy participants. The primary objective was to evaluate the safety and tolerability of KIT2014. The secondary objective was to evaluate blood plasma pharmacokinetics.

For more information, visit clinicaltrials.gov NCT06659757.

Kither Biotech’s leadership team will be attending the BIO International Convention in San Diego, US, from 22–25 June 2026. The team will be available to meet investors, pharmaceutical and biotech partners, research analysts, and potential collaborators. To schedule a meeting, please contact: info@kitherbiotech.com.

Contact Information

Kither Biotech
Dr. Dimitrios Goundis
Chief Executive Officer
Email: info@kitherbiotech.com

Optimum Strategic Communications
Stephen Adams / Aoife Minihan / Ben Cowe
Tel: +44 203 821 6420
Email: kither@optimumcomms.com

Notes for editors

About Kither Biotech
Kither Biotech is a clinical-stage biopharmaceutical company focused on developing innovative therapies for respiratory diseases. The company’s lead program, KIT2014, represents a novel approach to treating respiratory conditions by targeting multiple respiratory disease pathways, simultaneously. Kither Biotech has successfully raised $26 million to date from leading life sciences investors including Claris Ventures, 2Invest, 3B Future Health, CDP Venture Capital, Italian Angels for Growth, Club degli Investitori, Ersel and ACE Venture. For more information, please visit www.kitherbiotech.com and follow us on LinkedIn.

About KIT2014
KIT2014 is a first-in-class inhaled peptide therapy that targets multiple pathways critical to respiratory disease pathophysiology. By equally inhibiting both phosphodiesterase 3 and 4 (PDE3/4) and enhancing cyclic adenosine monophosphate (cAMP) levels in airway cells, KIT2014 improves airway flow via relaxation of airway smooth muscle and bronchodilation, reduces epithelial and neutrophil-driven inflammation, and increases CFTR gating to improve chloride ion transport and airway mucus hydration and clearance. Inhaled delivery allows direct targeting of the lungs while minimising systemic exposure, potentially offering an improved safety profile compared to similar therapies with greater systemic exposure and side effects.

About KIT2014’s target indications
KIT2014 has the potential to address significant unmet needs across respiratory diseases including COPD, NCFB and CF.

Chronic obstructive pulmonary disease (COPD) affects more than 400 million people globally, and continues to be the third largest cause of death worldwide. It is an irreversible airflow-limiting disease primarily caused by smoking and environmental exposures, characterised by chronic respiratory symptoms, and progressive decline in lung function. The underlying pathology is driven by inflammation leading to small airway remodelling, and parenchymal destruction.

Non-CF bronchiectasis (NCFB) impacts approximately 500,000 people in the US and a similar number in Europe, with limited treatment options available. It is a chronic airway disease characterised by permanent dilation of the bronchi, leading to cough, sputum production, and recurrent infective exacerbations. The disease creates a vicious cycle of mucus accumulation, infection and neutrophilic inflammation.

Cystic fibrosis (CF) affects approximately 130,000 people worldwide and, despite advances in CFTR modulators, many patients continue to experience persistent inflammation and recurrent infections. It is a life-limiting genetic disease caused by mutations in the CFTR gene, leading to defective chloride ion transport in multiple organ systems. In the lungs, this results in thick, sticky mucus buildup promoting chronic bacterial infections, persistent inflammation and decline in lung function.

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