The FDA Grants Breakthrough Therapy Designation To Insmed Incorporated’s (NASDAQ:INSM) Brensicatib in Treatment of NCFBE

Insmed Incorporated (NASDAQ:INSM) announced the FDA has granted its brensocatib (INS1007) a breakthrough therapy designation for the reduction of exacerbations in the treatment non-cystic fibrosis bronchiectasis adult patients.

Insmed receives breakthrough therapy designation for brensocatib

Brensocatib is the company’s proprietary oral dipeptidyl peptidase 1 (DDP1) reversible inhibitor that the company is currently developing. It is meant for bronchiectasis treatment as well as other inflammatory diseases. The breakthrough designation is meant to accelerate the development as well as the review process of therapies meant for the treatment of severe or life-threatening diseases. It is given for drugs in which initial clinical evidence shows that it will have considerable effect relative to available therapy.

The advantages of a breakthrough designation in the drug development process include regular meetings and communication with the FDA. Equally, there is eligibility for commencing priority review and intensive guidance on the drug development program’s efficiency.

Martina Flammer, the Chief Medical Officer of Insmed, was delighted to receive the breakthrough therapy designation for brensocatib in NCFBE treatment. Martina said that the move signifies the strength of the company’s data from the second phase WILLOW study. It also shows the potential of brensocatib becoming a first-in-class therapy for the treatment of bronchiectasis. Currently, no approved therapy specifically targets these chronic and severe pulmonary diseases in the US, Japan, or Europe. The chief medical officer added that they are looking forward to continuing working with the FDA to advance the development of this therapy.

Insmed to provide full WILLOW study data on June 24

The company received the breakthrough therapy designation for the drug based on the positive second phase WILLOW study. The company conducted a double-blind, randomized, placebo-controlled study of brensocatib in the treatment of NCGBE with full results expected to be presented on June 24, 2020.

Insmed will present the results in a virtual clinical study session that the American Thoracic Society will host. The company is expected to hold a conference call after the oral session, after which the principal investigator of the study will discuss the data.