KAKEN PHARMACEUTICAL

KalVista Completes Enrollment in Pediatric HAE Trial for Oral Therapy Sebetralstat

2 months ago

• KalVista Pharmaceuticals has completed enrollment in the KONFIDENT-KID trial of sebetralstat, an oral plasma kallikrein inhibitor for children aged 2-11 with hereditary angioedema, a full year ahead of schedule. • Due to overwhelming interest from families affected by HAE, the trial was expanded from 24 to nearly 36 children across seven countries in Asia, Europe, and North America. • If approved, sebetralstat would become the first oral on-demand therapy for pediatric HAE patients, with initial results expected later this year and a supplemental New Drug Application planned by mid-2026.

Alumis to Present 52-Week Phase 2 Data for Novel TYK2 Inhibitor in Psoriasis at AAD 2025

3 months ago

• Alumis will showcase long-term safety and efficacy data for ESK-001, their oral TYK2 inhibitor, in moderate-to-severe plaque psoriasis through multiple presentations at the 2025 AAD annual meeting. • The company has accelerated the timeline for their Phase 3 ONWARD program, with topline data now expected in Q1 2026, reflecting strong patient enrollment and investigator interest. • ESK-001 demonstrated sustained PASI score improvements and favorable safety profile in interim 28-week open-label extension data, with most patients achieving PASI 75 at the 40mg twice-daily dose.

Sebetralstat Receives Orphan Drug Designation in Japan, NDA Submitted for HAE Treatment

4 months ago

• KalVista's sebetralstat has been granted Orphan Drug Designation by Japan's MHLW, potentially expediting its approval for hereditary angioedema (HAE). • A New Drug Application (NDA) for sebetralstat has been submitted in Japan, seeking approval for on-demand treatment of HAE attacks in patients 12 and older. • Sebeteralstat, if approved, would be the first oral on-demand treatment option available for HAE patients in Japan, addressing a significant unmet need. • The NDA submission is backed by positive data from the KONFIDENT Phase 3 trial and the KONFIDENT-S open-label extension study, demonstrating safety and efficacy.

Kymera Therapeutics Advances Immunology Pipeline with Promising Degrader Programs

5 months ago

• Kymera Therapeutics is progressing KT-621, a STAT6 degrader, with Phase 1 data expected in Q2 2025 and Phase 1b trials in atopic dermatitis planned for Q2 2025. • The company's TYK2 degrader, KT-295, is set to enter Phase 1 testing in Q2 2025, with results anticipated by the end of the year, expanding Kymera's immunology portfolio. • Sanofi-partnered IRAK4 degrader, KT-474, is in Phase 2b studies for hidradenitis suppurativa and atopic dermatitis, with completion expected by mid-2026, showing advancement in clinical trials. • Kymera plans to unveil a novel oral immunology program targeting an undrugged transcription factor in H1 2025, with clinical testing slated for early 2026, demonstrating pipeline expansion.