Deucrictibant

European Commission Grants Orphan Designation to Pharvaris' Deucrictibant for Bradykinin-Mediated Angioedema

2 months ago

• The European Commission has granted orphan designation to Pharvaris' investigational drug deucrictibant for treating bradykinin-mediated angioedema, following similar FDA designation in 2022. • Deucrictibant, an oral bradykinin B2 receptor antagonist, is currently in Phase 3 clinical trials for hereditary angioedema (HAE) with potential to address broader bradykinin-mediated angioedema conditions. • Pharvaris is developing two oral formulations of deucrictibant: an extended-release tablet for prophylactic treatment and an immediate-release capsule for on-demand therapy of angioedema attacks.

Deucrictibant Shows Promising Long-term Safety and Efficacy in Hereditary Angioedema Treatment

3 months ago

• Pharvaris's oral drug deucrictibant demonstrated strong efficacy in Phase 3 studies, with patients experiencing a median of zero attack days per month during long-term prophylactic treatment. • The medication showed consistent safety and efficacy in treating both upper airway and non-upper airway HAE attacks, with rapid and complete symptom resolution using a single dose. • Clinical data revealed significant improvements in patients' quality of life, particularly in functioning and psychological aspects, addressing key concerns in the HAE community.

Major Advances in Angioedema Pipeline: Intellia's Gene Therapy Enters Phase 3 as Multiple Companies Race for Novel Treatments

3 months ago

• Intellia Therapeutics has initiated Phase 3 trials for NTLA-2002, a groundbreaking CRISPR-based gene therapy for hereditary angioedema, with potential U.S. launch targeted for 2027. • KalVista Pharmaceuticals' sebetralstat receives Orphan Drug Designation in Japan, marking progress toward the first oral on-demand treatment for HAE attacks. • The global angioedema pipeline includes 20+ companies developing innovative therapies, with several promising candidates in late-stage development from companies like ADARx, BioMarin, and Astria Therapeutics.

Pharvaris Expands Deucrictibant Development to Acquired Angioedema Following Promising Early Data

4 months ago

Pharvaris announces plans to initiate a clinical trial for deucrictibant in acquired angioedema, expanding beyond its ongoing Phase 3 trials in hereditary angioedema. The decision follows encouraging results in three patients, as the company advances its bradykinin B2 receptor antagonist program with both immediate and extended-release formulations.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Major Breakthroughs in HAE Treatment: 2024 Highlights Gene Editing and Novel Therapeutics

5 months ago

2024 marked significant advances in hereditary angioedema (HAE) treatment, with Intellia's gene-editing therapy NTLA-2002 showing a remarkable 95% reduction in monthly attacks. The year also saw important developments in multiple therapeutic candidates, including donidalorsen and garadacimab, while established treatments like Takhzyro demonstrated continued efficacy in adolescent populations.

Pharvaris Advances Deucrictibant for HAE and AAE, Outlines 2025 Priorities

6 months ago

• Pharvaris is progressing with Phase 3 trials for deucrictibant, targeting both on-demand treatment and prophylactic use for hereditary angioedema (HAE). • Clinical development plans are underway to explore deucrictibant's potential in treating acquired angioedema due to C1-INH deficiency (AAE-C1INH), addressing an unmet medical need. • The company anticipates topline data from the RAPIDe-3 trial in Q1 2026 and CHAPTER-3 trial in the second half of 2026, with a strong cash position to support these initiatives. • Recent presentations at medical congresses highlighted positive long-term extension data for deucrictibant, reinforcing its potential as a preferred HAE therapy.

BRAIN Biotech AG Secures €128.88 Million Royalty Monetization Deal for Deucrictibant

8 months ago

• BRAIN Biotech AG заключила сделку по монетизации роялти на сумму до 128,88 млн евро с Royalty Pharma в отношении исследуемого фармацевтического соединения деукриктибант. • BRAIN Biotech получит авансовый платеж в размере 18,41 млн евро, потенциальные промежуточные платежи за нормативное соответствие в размере до 18,42 млн евро и долгосрочные промежуточные платежи, связанные с продажами, в размере до 92,05 млн евро. • Деукриктибант, часть конвейера BioIncubator компании, в настоящее время находится на стадии клинической разработки компанией Pharvaris NV для лечения наследственного ангионевротического отека. • Чистая выручка от этой транзакции будет использована BRAIN Biotech для финансирования будущего роста и погашения кредитов.

Deucrictibant Shows Sustained Benefits in Hereditary Angioedema Treatment

8 months ago

• Data from open-label extensions of Phase 2 trials demonstrate deucrictibant's sustained efficacy in preventing and treating swelling attacks associated with hereditary angioedema (HAE). • Results showed a 93% reduction in HAE attack rates after one year in the extension period, with a median monthly attack rate of zero. • Pharvaris is advancing deucrictibant with Phase 3 trials for both on-demand (RAPIDe-3) and prophylactic (CHAPTER-3) treatment of HAE, and exploring its potential in acquired angioedema. • The median time to onset of symptom relief was 1.1 hours, with nearly all (98.5%) of attacks starting to ease within 12 hours.

Drug Development Updates