KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) announced that it presented data demonstrating the effectiveness of sebetralstat in reducing anxiety during hereditary angioedema (HAE) attacks at the HAEi Global Angioedema Forum (GAF) in Copenhagen, Denmark, on October 4-5, 2024. This data, derived from the KONFIDENT phase 3 clinical trial, was initially disclosed in February 2024. Sebetralstat is a novel investigational oral plasma kallikrein inhibitor aimed at the on-demand treatment of HAE attacks in adults and adolescents aged 12 and older.
KalVista Pharmaceuticals presented findings from the KONFIDENT phase 3 clinical trial at the HAEi Global Angioedema Forum in Copenhagen, showing that sebetralstat significantly reduces anxiety during hereditary angioedema (HAE) attacks. This analysis, led by Dr. William R. Lumry from AARA Research Center, highlighted how patients reported anxiety levels using a Modified Generalized Anxiety Numeric Rating Scale. Results indicated that anxiety decreased among patients taking sebetralstat, with notable reductions observed at both 300mg (P=0.004 and P=0.022) and 600mg (P=0.0008 and P=0.0012) doses compared to placebo.
Participants with moderate-to-extreme anxiety showed a change from baseline of −2.8 (−3.6, −1.9) for both sebetralstat groups at 4 hours, versus −1.3 (−2.2, −0.4) for placebo. At 12 hours, reductions were even greater: −3.5 (−4.3, −2.6) for 300mg and −4.3 (−5.2, −3.5) for 600mg, compared to −1.7 (−2.6, −0.8) for placebo. Importantly, anxiety reduction correlated with a quicker onset of symptom relief.
Dr. Lumry emphasized the importance of these findings, stating, “People with HAE often face significant anxiety during attacks, impacting their quality of life. Sebetralstat’s ability to significantly reduce this anxiety, especially for those with moderate-to-extreme anxiety, highlights its potential value for HAE patients.”
The forum also featured additional poster presentations, including:
- Anxiety with Parenteral Treatments: Riccardo Senter discussed survey results indicating that many patients experience anxiety related to anticipated treatment, particularly among adolescents and those with previous anxiety diagnoses.
- The HAE Attack Journey: Douglas Jones presented findings showing that patients often delay treatment due to anxiety, with longer delays reported by those feeling more anxious.
- Impact of Delayed Treatment: Patrick Yong’s research highlighted that most participants waited over an hour to treat their attacks, adversely affecting their quality of life and work productivity.
- Quality of Life in UK Patients: Yong also noted that a significant proportion of respondents receiving long-term prophylaxis reported severe attacks, with considerable burdens on physical, mental, and social well-being.
- Efficacy Across Subgroups: Andrea Zanichelli’s analysis confirmed that sebetralstat’s efficacy and safety were consistent across European and U.S. patient subgroups.
- Benefits of Early Treatment: Mar Guilarte reported that patients treating attacks early experienced greater overall benefits and less anxiety compared to those who delayed.
- Future Oral Treatments: Anna Valerieva noted that patients using parenteral treatments indicated they would likely treat more attacks and feel less anxious with the availability of oral on-demand options.
- Diagnosis Delays in Normal C1INH Patients: Markus Magerl pointed out significant delays in diagnosing HAE for patients with normal C1INH, underscoring the need for standardized diagnostic pathways.
These findings collectively underscore the importance of addressing anxiety and improving treatment options for those living with HAE.
