KalVista Pharma Presents Data at 2024 Allergy and Dermatology Conferences

KalVista Pharmaceuticals, Inc., a prominent entity in the pharmaceutical industry specializing in oral medicines for diseases with significant unmet needs, has recently shared significant findings from its phase 3 KONFIDENT trial. The trial, which focuses on the on-demand treatment of hereditary angioedema (HAE) using sebetralstat, includes a noteworthy US subgroup analysis presented at the Eastern Allergy Conference (EAC) 2024.

The KONFIDENT trial is pioneering in its inclusion of Japanese sites as part of its phase 3 HAE development program. Findings from the US subgroup revealed that the median time from the onset of an attack to the administration of sebetralstat was approximately 38 minutes, compared to the overall trial population's median time of 41 minutes. Additionally, the median time to the beginning of symptom relief for the 300 mg dose in the US subgroup was recorded at 1.28 hours, slightly faster than the overall trial population's median time of 1.61 hours.

Despite the increasing adoption of long-term prophylaxis (LTP) therapies in the US, the volume of on-demand treatments for HAE has remained stable. From a retrospective analysis of a large multi-payer claims database, it was observed that the annual variability in the number of on-demand syringes and vials dispensed per quarter has remained relatively consistent, with variations falling within 3% and 10% of the baseline figures from Q3 2018 to Q3 2023.

In terms of healthcare costs, the analysis of claims data indicated that HAE-related non-pharmacy resource utilization costs for patients using non-androgen LTP are substantial, averaging more than $641,000 per patient annually. Approximately one-third of these patients had at least one HAE-related emergency room visit, and nearly a quarter had at least one home health visit related to HAE.

The impact of HAE attacks on patients' quality of life (QoL) was also examined. It was found that treated attacks, regardless of whether patients were on non-androgen LTP or on-demand treatment only, similarly affected their physical and social QoL. Attacks treated within an hour were linked to a lower impact on QoL.

Furthermore, the attacks had significant ramifications on the employment and work productivity of patients. Both groups—those on non-androgen LTP and those receiving on-demand treatment—reported impairments in their ability to work, including substantial absenteeism, reduced productivity, and presenteeism for those who managed to work during an attack.

Among patients with untreated attacks, the severity often escalated, spreading to other body parts and leading to social isolation and adverse impacts on their physical and mental health. Seventy percent of patients reported that their last untreated attack affected their energy levels, with 55% of LTP patients and 22% of on-demand only patients expressing reluctance to go out in public due to their condition.

The Japanese subgroup's results, presented at the Japanese Dermatological Association's 123rd Annual Meeting, indicated a consistent primary endpoint with the overall trial population. Sebetralstat was well tolerated among Japanese participants, with no treatment-related adverse events (TEAEs), serious or severe TEAEs, or events leading to study discontinuation.

Ben Palleiko, CEO of KalVista Pharmaceuticals, emphasized the consistency of results across various subgroups in the KONFIDENT trial, highlighting the ongoing unmet need in HAE management despite advancements in LTP therapies. He pointed out that even patients on LTP continue to experience attacks with comparable impacts as those relying solely on on-demand treatments. Additionally, the stability of on-demand prescription volumes, despite new prophylaxis options, underscores the potential of sebetralstat to revolutionize HAE management.

KalVista Pharmaceuticals aims to submit a new drug application to the U.S. FDA for sebetralstat in June 2024, with anticipated approvals in the UK, Europe, and Japan later in the year. The company remains committed to addressing the significant unmet needs in HAE treatment and improving patient outcomes through its innovative oral therapies.