What do you get when you combine the efforts of one of the world’s leading respiratory drugmakers with a global pioneer in biological medicines? You get a next-gen treatment like Tezspire, which according to pivotal results revealed this month, could become an important new therapy for an underserved respiratory condition.
Co-developed by biopharma giants AstraZeneca and Amgen, and approved in 2021 for severe asthma, Tezspire raked in combined sales of $1.2 billion for the full year 2024. Now, late-stage data in the respiratory condition chronic rhinosinusitis with nasal polyps, or CRSwNP, showed that the drug reduces the need for surgery by a startling 98% and the use of corticosteroids by 88%.
The results underscore a growing conversation about biologic treatments that offer a more comprehensive view of immunological pathways as disease targets. While competitors in CRSwNP include biologic blockbusters such as Dupixent from Sanofi and Regeneron, Novartis’ Xolair and GSK’s Nucala, Tezspire stands apart by aiming at a target higher in the immunological cascade, said Andrew Menzies-Gow, vice president of respiratory and immunology in global biopharmaceuticals medical at AstraZeneca.
“As we discover new mechanisms, our ambition will quite rightly improve — we will aim higher to achieve remission and prevent disease progression.”
Andrew Menzies-Gow
Vice president, respiratory and immunology, AstraZeneca
By reducing cytokine release in the airway’s first line of defense, the epithelium, Tezspire is potentially more versatile than other treatments on the market.
“It’s very logical to move from these first-generation biologics to now targeting the epithelial cytokine at the top, focusing on the key role of the epithelium in driving downstream disease,” Menzies-Gow said. “If we think about our epithelium in our airway and then in the nose, it has a really important barrier function. As we breathe in and out, it’s the first thing that comes into contact with viruses, pollution, cigarette smoke, allergens and more.”
And with Tezspire’s ability to reduce the need for invasive surgery or corticosteroids that carry a host of long-term side effects, AstraZeneca and Amgen are looking to carve out a new pocket in the respiratory landscape.
‘We will aim higher’
Dr. Alison Church, vice president of global development for inflammation at Amgen, recalls a time during her medical fellowship before biologics were introduced to the space, when she felt there must be a better way to address CRSwNP.
“I’m a pediatric allergist and immunologist by training, and I can recall an 18-year-old coming out of his second surgery for nasal polyps, and I didn’t have much to offer him,” Church said. “I couldn’t be sure that anything I did would prevent him from having to have another surgery.”
Now, the growing impact of biologics on respiratory conditions has given drug developers more hope for the future in conditions like CRSwNP.
“I love the immune system, but I would be remiss to tell you that I know everything about it despite many years in the field, and there are still discovery efforts underway to find new drivers of disease — there are still plenty of potential targets that could be disease modifying or advance the current standard of care,” Church said. “It’s an exciting time in immunology and across pharma to see how much is being invested in developing new medicines for new targets.”
These new opportunities raise the bar for what’s possible, Menzies-Gow said.
“Our level of ambition is changing, and you can see that as we start to regularly talk about achieving clinical remission for people with severe asthma and even talk about defining remission for CRSwNPs, as well,” Menzies-Gow said. “As we discover new mechanisms, our ambition will quite rightly improve — we will aim higher to achieve remission and prevent disease progression.”
The companies have filed for regulatory approval of Tezspire in CNSwNP, and although the trial didn’t pit the drug against biologic competitors due to design differences, analysts have pointed to “best-in-disease” potential. Commercially, Amgen owns the U.S. rights while AstraZeneca sells Tezspire elsewhere.
The companies are also taking next-gen ambition to another tricky disease target: chronic obstructive pulmonary disorder. With successful mid-stage results in hand, they plan to launch a large phase 3 study in the first half of this year. It’s also in a late-stage study to treat eosinophilic esophagitis, characterized by inflammation of the esophagus.
As far as the market opportunity in CRSwNP, Church sees room for multiple biologics to make a difference for patients.
“There’s enough room in the marketplace for different treatments — Tezspire has a different mechanism of action than Dupixent, targeting the top of the inflammatory cascade, where it all starts, right when the epithelium is perturbed and releases cytokines that drive [the] downstream inflammatory cascade,” Church said.
Biologics overall are becoming a more prominent treatment for different conditions, and doctors are prescribing them earlier in the course of a disease, Church said.
“We’re looking to be more selective in our targets, and that’s one thing biologics do,” Church said. “Physicians around the globe are becoming more comfortable prescribing biologics because they’ve seen the benefit. You’re not waiting and using biologics as the last line of therapy, and now the patients who meet the prescribing information and the severity for which biologics are indicated are being prescribed those medications at the appropriate point of their disease.”
The art of Big Pharma collaboration
Collaboration between two powerhouses like AstraZeneca and Amgen comes with a bevy of moving pieces, but for the two biopharmas who have worked together since 2012, the partnership is now a well-oiled machine, Church said.
While both companies have enough bandwidth to take on the world of biologics and respiratory, they bring different strengths to the table that have made Tezspire what it is today. Amgen’s biologic expertise and AstraZeneca’s respiratory disease specialty has made the collaboration more than the sum of its parts.
“Amgen has a long history in the inflammation space of discovery and development, and of course, AstraZeneca is a powerhouse in respiratory, so it’s a nice collaboration across the two companies to develop Tezspire,” Church said. “The teams work seamlessly together in terms of developing clinical study designs, indications of interest, and we work very well as a unit.”
For Menzies-Gow, Tezspire’s versatility is a direct result of a successful partnership.
“Clearly there is very good synergy between the two companies, and we’re delivering the medicine to an increasing number of patients with new indications,” he said.
