Sebetralstat treatment provides relief from mild and moderate hereditary angioedema (HAE) attacks, according to results from a phase 2 clinical trial.

The trial results were presented at the Annual Conference of the Australasian Society of Clinical Immunology and Allergy (ASCIA), which took place in Melbourne, Australia, between August 30 and September 2, 2022. The treatment effects were similar regardless of the severity of the attacks at baseline.

During the randomized, double-blind, placebo-controlled, crossover trial, the aim of which was to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of sebetralstat in treating HAE attacks, 60 patients completed at least 1 treatment. The patients each had HAE type 1 or 2 and had experienced at least 3 attacks in the past 93 days.


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Symptom relief was achieved for 69.2% of mild HAE attacks within 12 hours of sebetralstat administration compared to 41.9% of attacks when patients were given a placebo. For moderate HAE attacks, sebetralstat administration led to symptom relief in 89.3% of cases compared to 60.9% with placebo in the same timeframe. Results were obtained using the Patient Global Impression of Change scale.

Read more about sebetralstat and other experimental therapies for hereditary angioedema

When a visual analog scale was used instead, symptom relief was achieved in 65.4% of cases in mild HAE attacks following sebetralstat administration compared to 22.6% with placebo, and 64.3% of moderate HAE attacks compared to 43.5% with placebo.

The Patient Global Impression of Change scale also showed that sebetralstat treatment led to an improvement in symptoms in 34.6% of mild HAE cases compared to 9.7% with placebo and in 78.6% of cases in moderate HAE attacks compared to 52.2% with placebo.

Sebetralstat is an experimental, on-demand plasma kallikrein inhibitor that KalVista Pharmaceuticals is developing to treat HAE attacks. 

References

Longhurst HJ, Smith MD, Yea C, Audhya P. P95: Sebetralstat effectiveness in the treatment of hereditary angioedema attacks rated mild or moderate at baseline in the phase 2 trial. Int Medicine J. Published online October 2, 2022. doi:10.1111/imj.94_15894 

A phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900 in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II. US National Library of Medicine. December 23, 2019. Updated January 6, 2021. Accessed October 7, 2022.