Inhalation

INH0223

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In the treatment of lung disease, a novel pathway known as excipient enhanced growth is progressing through toxicological studies and showing promise for the treatment of both asthma and lung cancer by delivering active molecules to target sites in the lungs. 26 February 2023 Inhalation Excipient enhanced growth (EEG): Expanding delivery options for the treatment of lung diseases Formulation and design approaches for excipient enhanced growth Maureen Kadleck, BSE a ; Joseph Churchman, BS a and Bryce Beverlin II, PhD b a Lonza AG b Quench Medical, Inc. Abstract In the treatment of lung disease, a novel pathway known as excipient enhanced growth is progressing through toxicological studies and showing promise for the treatment of both asthma and lung cancer by delivering active molecules to target sites in the lungs. e following article expounds on the formulation development process for two candidates, budesonide and gemcitabine, for local lung delivery using this formulation approach in combination with tradi- tional spray drying for the generation of respirable engineered particles. Background Local treatment of lung diseases by the inhalation route is a therapeutic area with increased inter- est following the COVID-19 pandemic, although platforms for delivery to the lung have been com- mon for centuries. Today, respiratory delivery, by either metered dose inhaler (MDI) or dry powder inhaler (DPI), is standard-of-care for numerous dis- eases, such as chronic obstructive pulmonary disease (COPD) and asthma. In recent years, local delivery has been investigated in clinical trials for additional lung indications such as pulmonary hypertension, lung infections and lung cancer. e reduced risk of systemic adverse effects and the potential for reduced dose are compelling advantages of local delivery. Lung cancer continues to have a poor prognosis in most patients, which can be attributed to the ineffec- tive delivery of drugs to the lung tissue with standard therapies. Inhaled delivery of pharmaceuticals is an approach that circumvents the shortcomings of stan- dard intravenous (IV) delivery, including trypano- phobia and hospital visits. Prior attempts at lung delivery have had issues either reaching the lungs or with treatment exhalation after initial delivery. However, an innovative excipient enhanced growth (EEG) platform for inhalation drug delivery offers a mechanism to overcome previous issues and has high feasibility for transporting a promising therapeutic agent directly into the lungs. Originally developed at Virginia Commonwealth University (VCU), the technology is now being commercialized by Quench Medical, Inc., which has partnered with Lonza AG, for the spray drying of two compounds to utilize the platform and fur- ther demonstrated its efficacy. e two compounds, budesonide and gemcitabine, are intended to treat asthma and non-small-cell lung cancer, respectively. Budesonide is precedented for lung delivery to treat asthma, but gemcitabine is limited to intravenous dosing. Both Quench Medical EEG programs are currently in toxicological studies and show promise. Rat studies, including lung histology, conducted by Quench Medical at Lovelace Biomedical Research Institute using this technique to deliver gemcitabine via inhalation to lung cancer tumors resulted in a significant decrease in lung weight and in the prev- alence of tumors. Figure 1 shows the lung weight results from the study while Figure 2 shows a qual- itative decrease in tumor prevalence [1]. Figure 1

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