KalVista Pharmaceuticals Presents Data at Eastern Allergy Conference 2024 and the Japanese Dermatological Association 2024

Rhea-AI Summary

KalVista Pharmaceuticals presented data from the US subgroup of the phase 3 KONFIDENT trial and real-world claims at the Eastern Allergy Conference 2024, and the Japanese subgroup at the Japanese Dermatological Association 2024. The US subgroup showed a median time to treatment of 38 minutes and symptom relief beginning at 1.3 hours, comparing favorably with overall trial results. Despite increased long-term prophylaxis use in the US, on-demand treatment prescriptions remain steady, with significant non-prescription healthcare costs. Japanese trial results were consistent with overall data, and sebetralstat was well tolerated with no serious adverse events. Real-world data also highlighted that HAE attacks impact quality of life and work productivity similarly for both prophylaxis and on-demand treatment patients.

Positive

• US subgroup median time to treatment was 38 minutes, faster than the overall trial median of 41 minutes.
• US subgroup median time to symptom relief was 1.28 hours, better than the overall trial median of 1.61 hours.
• Japanese subgroup data consistent with overall trial results.
• Sebetralstat well tolerated in Japanese subgroup with no serious adverse events.
• On-demand prescription volumes have remained stable despite increased prophylaxis use.

Negative

• HAE-related non-pharmacy resource utilization costs average >$641,000 per patient per year.
• 33% of patients on non-androgen LTP had at least one HAE-related ER visit.
• 22% of patients on non-androgen LTP had at least one HAE-related home health visit.
• HAE attacks significantly impact work productivity and quality of life.

Insights

Medical Research Analyst

The KONFIDENT trial data presented by KalVista Pharmaceuticals provides significant insights into the treatment landscape for hereditary angioedema (HAE). The trial's findings, particularly the median time to treatment and symptom relief for the US subgroup, indicate a faster treatment response compared to the overall population, which could suggest enhanced efficacy of sebetralstat in this subgroup.

This result is important because it highlights that sebetralstat could potentially offer quicker relief for patients, making it a valuable option for managing HAE attacks. Moreover, the data from the Japanese subgroup, although limited, also show consistency with the overall trial, which is beneficial for the drug's potential approval in diverse populations.

The presentation also underscores the substantial non-pharmacy healthcare costs associated with HAE management. An average of $641,000 per patient annually points to a high burden on healthcare systems. This economic insight emphasizes the need for effective and timely treatment options, potentially positioning sebetralstat as a cost-saving solution in the long run.

Financial Analyst

From a financial standpoint, the data presented could be viewed as a positive signal for KalVista Pharmaceuticals. The consistency of clinical trial results across different regions, including the US and Japan, suggests robust efficacy and safety of sebetralstat. This consistency is important for gaining regulatory approvals and market acceptance globally.

Furthermore, the stable demand for on-demand HAE treatments in the face of increasing long-term prophylaxis options is an encouraging indicator for sebetralstat's market potential. If approved, sebetralstat could tap into a relatively stable and substantial market despite the introduction of other prophylactic treatments.

However, investors should also consider the high healthcare costs associated with HAE management, as indicated by the retrospective analysis. While this underscores the need for effective treatments, it also highlights the financial burden on patients and insurers, which could influence market dynamics and pricing strategies. Investors should monitor further developments and regulatory milestones closely.

Overall, the presented data strengthens the drug's value proposition and could positively impact KalVista's stock performance, reflecting investor confidence in their product pipeline.

– US subgroup in the phase 3 KONFIDENT trial demonstrates median time to treatment of 38 minutes and time to beginning of symptom relief 1.3 hours –

– Despite growing use of long-term prophylaxis therapies in the US on-demand treatment prescription volumes stay stable and non-prescription healthcare costs for management of HAE remain substantial –

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that it presented the US subgroup analysis from the sebetralstat phase 3 KONFIDENT trial and real-world claims and patient survey data at the Eastern Allergy Conference (EAC) 2024, as well as the Japanese subgroup from KONFIDENT at the 123rd Annual Meeting of the Japanese Dermatological Association (JDA) 2024. KONFIDENT is the first pivotal phase 3 trial to include Japanese sites in an HAE development program.

The following presentations occurred at EAC 2024:

• Sebetralstat for On-demand Treatment of Hereditary Angioedema Attacks: US Subgroup Analysis from the Double-blind, Placebo-controlled Phase 3 KONFIDENT Trial: Daniel Soteres, Asthma & Allergy Associates P.C., Colorado Springs, Colorado, United States. (Poster presentation)
  • Median time from attack onset to administration was 38 minutes (IQR 5-124) for the US subgroup (78 attacks), which compares favorably to the median time to treatment of 41 minutes (IQR 6-140) in the overall trial population
  • Median time to beginning of symptom relief for 300 mg in the US subgroup was 1.28 hours (IQR 0.77-3.12), which also compares favorably to the 300 mg median time to beginning of symptom relief of 1.61 hours (IQR 0.78-7.04) for the overall trial population
• Trends in volume of on-demand hereditary angioedema treatments in the US: A retrospective analysis of a large multi-payer claims database: Daniel Soteres, Asthma & Allergy Associates P.C., Colorado Springs, Colorado, United States. (Poster presentation)
  • Despite the advent of multiple non-androgen LTPs since 2017, the overall trend in the total number of claims reimbursed and quantity dispensed for on-demand treatments has remained stable in the US
  • Average year-over-year variability in the total number of on-demand syringes and vials dispensed per quarter has remained within 3% and 10%, respectively, of baseline from Q3 2018 – Q3 2023
• Healthcare Costs Among Commercially Insured Patients with Hereditary Angioedema Managed with Long-term Prophylaxis: a Retrospective US Claims Database Analysis: Daniel Soteres, Asthma & Allergy Associates P.C., Colorado Springs, Colorado, United States. (Poster presentation)
  • Claims database analysis revealed that HAE-related non-pharmacy resource utilization costs among patients receiving non-androgen LTP were substantial, averaging >$641,000 in HAE healthcare costs per patient per year
  • Approximately one-third of patients receiving non-androgen LTP had ≥1 HAE-related ER visits during follow-up (33%), and nearly one-quarter (22%) had ≥1 HAE-related home health visit
• Real-World Impact of Treated Hereditary Angioedema Attacks on Patients’ Quality of Life: Maeve O’Connor, Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte, NC, United States. (Poster presentation)
  • Attacks occurring among patients receiving non-androgen LTP and those receiving on-demand treatment only similarly impact physical and social quality of life (QoL)
  • Attacks treated in <1 hour were associated with a lower impact on QoL
• Real-world Impact of Treated Hereditary Angioedema Attacks on Patients’ Employment and Work Productivity: Maeve O’Connor, Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte, NC, United States. (Poster presentation)
  • HAE attacks among patients receiving non-androgen LTP and those receiving on-demand treatment only similarly impacted the work lives of employed patients resulting in impairments in their ability to work, substantial absenteeism, reduced productivity, and presenteeism among those who were able to work
• Burden of the Untreated Attacks and its Impact on Social, Mental and Physical Health: Maeve O’Connor, Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte, NC, United States. (Poster presentation)
  • Patients, including those taking LTP, reported that untreated HAE attacks often progressed in severity, migrated to other locations, and were associated with social isolation and impact on physical/mental health
  • 70% of patients indicated that their last untreated attack had an impact on their energy levels; 55% and 22% of LTP and on-demand only patients, respectively, felt reluctant to go out in public

The following presentation occurred at the Annual Meeting of the JDA 2024:

• Sebetralstat KONFIDENT Is the First Phase 3 On-demand HAE Trial to Include Japanese Sites: Daisuke Honda, Chiba University Graduate School of Medicine, Chiba, Japan. (Poster presentation)
  • Despite the relatively small number of attacks that were treated in the subgroup of Japanese KONFIDENT participants, primary endpoint results were consistent with those observed in the overall trial population
  • Among Japanese participants, sebetralstat was well tolerated with no treatment-related TEAEs, no serious or severe TEAEs, and no TEAEs leading to study discontinuation

“We have observed exceptional consistency of results across subgroups in the KONFIDENT trial including attack severity, location, treatment paradigm (with or without long-term prophylaxis) and geography,” said Ben Palleiko, CEO of KalVista Pharmaceuticals. “This data further highlights that patients on LTP generally continue to have attacks, and that those attacks have similar impact as on-demand only users, showing the continued unmet need although it is not generally recognized. In parallel, claims data also highlight that on-demand prescription volumes have remained stable despite the introduction of subcutaneous and oral long-term prophylaxis options. Sebetralstat has the potential to transform the management of HAE.”

Links to all posters and presentations can be found on the KalVista website under “Publications”.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024. The Company anticipates submitting a new drug application to the U.S. Food and Drug Administration (FDA) for sebetralstat in June 2024 and expects to file for approval in the UK, Europe and Japan later in 2024.

For more information about KalVista, please visit www.kalvista.com.

Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA or other international regulatory agencies, our expectations about safety and efficacy of our product candidates, our ability to obtain regulatory approvals for sebetralstat and other candidates in development within our expected timelines or at all, our success in engaging with potential commercial partners, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, our ability to commence pediatric trials of sebetralstat and develop an ODT formulation, the future progress and potential success of our oral Factor XIIa program, our ability to reduce spending on discovery and preclinical activities, and our expectation to become cash flow positive. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2023, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240606656084/en/

KalVista Pharmaceuticals, Inc.

Jarrod Aldom

Vice President, Corporate Communications

(201) 705-0254

jarrod.aldom@kalvista.com

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Source: KalVista Pharmaceuticals, Inc.

FAQ

What were the key results of the US subgroup in KalVista Pharmaceuticals' KONFIDENT trial?

The US subgroup showed a median time to treatment of 38 minutes and median time to symptom relief beginning at 1.3 hours.

How did on-demand prescription volumes change in the US despite long-term prophylaxis?

On-demand prescription volumes remained stable despite the increased use of long-term prophylaxis therapies.

What were the healthcare costs associated with non-androgen long-term prophylaxis for HAE?

Non-pharmacy resource utilization costs averaged over $641,000 per patient per year.

How did HAE attacks impact the quality of life and work productivity?

HAE attacks impacted physical, social quality of life, and work productivity similarly among patients using both non-androgen LTP and on-demand treatments.

Were there any serious adverse events reported in the Japanese subgroup of the KONFIDENT trial?

No serious or severe treatment-related adverse events were reported in the Japanese subgroup.