Will Lewis, Chairman & CEO,

INSMED

"Insmed developed a drug-device combination that became the first approved therapy to treat patients with a refractory form of a rare and serious lung infection."

Could you update our readers on how 2021 was for Insmed?

In 2021, the company expanded upon the growth it experienced in 2020, which had been the most significant year in the company’s history to date. As a company focused on rare diseases, Insmed is currently pursuing four different pillars. Our first pillar and lead program is now approved in the US, Europe and Japan, and has commercially launched. We have advanced our other two development programs, both pulmonary-related, and we added our fourth pillar focused on translational medicine.

Can you provide more insight into the process of bringing your commercial drug to the market?

Insmed developed a drug-device combination that became the first approved therapy to treat patients with a refractory form of a rare and serious lung infection. We are now evaluating this therapy in a frontline patient population, with two clinical trials that are underway.

What is the status of Insmed’s second and third pillars?

The company’s second pillar, brensocatib, is currently in a phase 3 clinical trial as the first investigational DPP1 inhibitor developed for neutrophil-driven inflammatory conditions. We aim to enroll more than 1,600 patients globally in the study to address bronchiectasis, a pulmonary condition that currently has no approved treatments. The drug is unique in that it targets the inflammatory process associated with bronchiectasis rather than the historically unsuccessful approach of treating with anti-infectives. Results from the phase 2 trial were published in the New England Journal of Medicine, the first time in nearly 20 years this journal has published on bronchiectasis. Given the mechanism the drug utilizes, we are evaluating or plan to study it in several other diseases such as cystic fibrosis, chronic rhinosinusitis without nasal polyps, and hidradenitis suppurativa.

Our third pillar is treprostinil palmitil inhalation powder (TPIP), a novel, investigational formulation of prostanoid, a class of drugs used for the treatment of pulmonary arterial hypertension (PAH). PAH is a serious, progressive, rare disease involving narrowing and constriction of the pulmonary arteries, making it difficult for the heart to pump blood effectively. TPIP relaxes the vasculature in a pulmonary setting. We currently have three phase 2 programs underway to evaluate the efficacy of TPIP in PAH and pulmonary hypertension associated with interstitial lung diseases.

What work is Insmed doing in the translational medicine space?

Our fourth pillar is translational medicine. In 2021, Insmed acquired three small companies with teams that are leaders in the fields of gene therapy, protein engineering, and protein manufacturing. This has augmented our existing research capabilities to develop the next generation of medicines utilizing cutting-edge technologies. Insmed wanted to develop an engine that could continuously produce impactful medicines to address rare and serious diseases and write the future of the company. Currently, we have close to 10 pre-clinical programs running and expect to have at least one IND filed every year for the next several years.

Has Insmed faced any supply chain challenges related to Covid-19?

Before the pandemic hit, we had already decided to invest in strengthening our supply chains because we see it as a corporate responsibility to have redundancy within your supply chain if you are in the world of pharmaceuticals. Not all materials are available in the US, so it is important to create inventory supply. We could not have anticipated a global disruption as severe as the pandemic, but our strategy has allowed us to avoid any significant disruptions for Insmed along the way.

The concept of globalization as an unfettered path which everyone is going to pursue has certainly been challenged over the past two years, first with the pandemic and now with increasing geopolitical turmoil. This changes the way companies regard just-in-time production and the origin of raw materials.

Can you elaborate on Insmed’s Investigator-Initiated Research initiative and what it means for the life sciences space?

At Insmed, we follow the science. The idea behind our investigator-initiated research program is to be responsive to key opinion leaders around the world who have ideas for how our therapies may be able to help patients. We want to support innovation in the life sciences ecosystem and will provide financial support and/or product supply for novel research proposals that answer important scientific and medical questions in our areas of interest. In some cases, we will even take on an investigator’s proposed research idea as inspiration for a study of our own.