Ekterly eases most HAE attacks within 20 minutes, trial data show
Now approved on-demand therapy found to stop attacks from getting worse
For most people with hereditary angioedema (HAE) given on-demand treatment in clinical trials with the now-approved therapy Ekterly (sebetralstat), swelling attacks stopped getting worse within 20 minutes of the oral medication being administered.
That’s according to new data that Kalvista Pharmaceuticals, Ekterly’s developer, shared earlier this month at the 20th German Allergy Congress [DGAKI] in Düsseldorf, Germany. The results were detailed in a poster titled “Time to End of Progression of Hereditary Angioedema Attacks Treated with Sebetralstat.”
“The data presented at DGAKI underscore the transformative potential of Ekterly for people living with HAE,” Paul Audhya, MD, chief medical officer of Kalvista, said in a company press release.
Audhya added that the “oral on-demand treatment has the ability to empower patients to better manage their condition, enabling earlier treatment of more attacks.”
HAE is a genetic disorder marked by swelling attacks driven by the overproduction of a signaling molecule called bradykinin. Ekterly is designed to lower bradykinin levels, thereby controlling swelling.
Ekterly approved for use in U.S., Europe for HAE patients 12 and older
Over the past few months, Ekterly has been successively approved in the U.S., the U.K., and, in September, in the European Union and Switzerland as an on-demand treatment for swelling attacks in HAE patients ages 12 and older.
Injectable on-demand HAE treatments were available before Ekterly’s approvals, but this medication is notably the first oral option for on-demand HAE management in any of these countries. Kalvista is planning to launch the therapy commercially in Germany in the coming months.
“With Ekterly now approved in the European Union, we look forward to bringing this innovation to more people living with HAE — beginning with a launch in Germany [before the end of this year] followed by additional European launches in 2026 and beyond,” Audhya said.
Ekterly’s approvals were largely based on data from the Phase 3 KONFIDENT trial (NCT05259917), which showed that on-demand treatment with the oral therapy led to faster symptom relief compared with a placebo.
An extension study called KONFIDENT-S (NCT05505916) is ongoing, and expected to run into next year. Previously reported data from the extension study have indicated that on-demand treatment with Ekterly can quickly resolve swelling attacks, including severe attacks and those affecting the airways.
Results show Ekterly took a median of 19.8 minutes to end attack progression
In this new analysis, a research team looked at data from more than 1,000 swelling attacks treated with Ekterly in KONFIDENT and KONFIDENT-S. Their aim was to determine how quickly the therapy led to the end of attack progression — that is, the point where swelling is no longer getting worse.
The results showed that the median time from taking Ekterly to the end of attack progression was 19.8 minutes.
Putting this result together with previous findings, the researchers then outlined the typical timeline seen in these trials for treating a swelling attack with Ekterly. The median time from noticing an attack to taking Ekterly was nine minutes. That means that, in most cases, swelling attacks stopped getting worse in less than half an hour after patients first noticed the episode was occurring, according to the data from the new analysis plus the earlier findings.
For people living with hereditary angioedema, halting an attack early is critical to minimize severity and reduce morbidity. The ability to achieve such rapid control across a broad range of attacks represents a meaningful step forward in the [on-demand] treatment of HAE.
The median time to the beginning of symptom relief was less than two hours after taking Ekterly, with most patients experiencing substantial symptom relief less than an hour after symptoms started to ease. In most cases, Ekterly led to complete attack resolution in less than a day.
“These data are very compelling. In both the pivotal KONFIDENT trial and the KONFIDENT-S extension, [Ekterly] consistently stopped attack progression in under 20 minutes,” said Markus Magerl, MD, a professor at Charité-Universitätsmedizin Berlin. Magerl presented the results at the conference.
“For people living with hereditary angioedema, halting an attack early is critical to minimize severity and reduce morbidity. The ability to achieve such rapid control across a broad range of attacks represents a meaningful step forward in the acute [on-demand] treatment of HAE,” Magerl said.
Separate poster focused on Ekterly use in European patients
In light of the recent approval of Ekterly in Europe, a separate poster was presented at the same conference to share an interim analysis of data from 69 participants in the KONFIDENT-S extension study. These individuals with HAE lived in 15 European countries. The poster was titled “Sebetralstat for On-Demand Treatment of Hereditary Angioedema Attacks in European Participants: Interim Analysis from KONFIDENT-S.”
Results from these European patients were overall consistent with findings from the broader study. The median time from recognition of an attack to Ekterly treatment was 16 minutes, and the median time to the end of attack progression was slightly longer than 20 minutes following Ekterly treatment. Most patients started experiencing symptom relief within two hours of taking Ekterly, and most attacks resolved in less than a day.
Other data from KONFIDENT-S presented at the conference indicated that Ekterly reduced attack-related anxiety, and that the on-demand therapy’s ability to resolve swelling attacks was consistent in the subset of patients receiving prophylactic treatment with Orladeyo (berotralstat) to prevent swelling attacks.
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