Highlights from

ATS 2019

American Thoracic Society international conference

Dallas, USA 17-22 May 2019

Dactolisib Phase 2b Clinical Trial Data Shows Reduction of Respiratory Tract Infections in Senior Asthma Patients

Dr Joan Mannick (resTORbio Inc, USA) presented new results from a phase 2b trial in which >900 65+ year old adults were treated with 10 mg dactolisib once daily for 16 weeks during the winter cold and flu season [1]. Dactolisib was observed to improve immune function by upregulation of antiviral gene expression and to significantly reduce the incidence of respiratory tract infections (RTIs) in senior adults with asthma.

Dactolisib is an oral, selective, and potent inhibitor of target of rapamycin complex 1 (TORC1). Dactolisib 10 mg once daily was observed to reduce the percentage of patients 65 years of age and older with asthma who developed laboratory-confirmed RTIs by 68.9% as compared with placebo (P=0.0001) and the rate of all RTIs (with or without laboratory confirmation) by 58.2% as compared with placebo (P=0.0002). Furthermore, the incidence of RTIs caused by multiple different viruses including rhinovirus (the most common viral cause of asthma exacerbations) was specifically reduced, implying direct clinical benefit for senior asthma patients at elevated risk.

As part of the aging process, the immune system weakens and becomes less effective at detecting and fighting infections such as RTIs. As a result, RTIs are more likely to be of greater severity, prolonged duration, and are more likely to be associated with medical complications in people age 65 years and older as compared with younger adults. “RTIs are one of the most common triggers of asthma exacerbations and are caused by many different kinds of viruses, most of which lack current treatments,” said Dr Mannick. “Preventing RTIs is of particular importance in asthmatics who are age 65 years and older. Asthma exacerbations are associated with a 5-fold increased risk of overall mortality in older as compared to younger adults with asthma.” In conclusion, dactolisib was well-tolerated, and adverse events were balanced between both study arms. Prophylactic treatment with dactolisib reduced the incidence of RTIs in patients 65 years of age and older with asthma.

  1. Mannick J et al. Oral TORC1 Inhibitor Dactolisib Enhances Immune Function and Reduces the Incidence of Respiratory Tract Infections in Elderly Subjects with Asthma. A2623 ATS 2019, 17-22 May, Dallas, USA.

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