Major Highlights and Insights from the AAAAI Annual Meeting, 2024

American Academy of Allergy, Asthma & Immunology (AAAAI) 2024 annual meeting, is the premier educational event for allergists/immunologists around the world that was held from February 23 to 26 at the Walter E. Washington Convention Center this year. The American Academy of Allergy, Asthma & Immunology (AAAAI) is the leading membership organization of more than 7,000 allergists/immunologists (in the United States, Canada, and 72 other countries) and patients’ trusted resource for allergies, asthma, and immune deficiency disorders.

Results of various promising emerging assets were presented during the recently concluded AAAAI conference. Some of the key highlights from the conference include:

Chronic Spontaneous Urticaria (CSU) Highlights

Major Pharma companies involved in presenting their Chronic Spontaneous Urticaria data readouts during the recently concluded AAAAI conference include Celldex Therapeutics, Novartis Pharmaceuticals, Sanofi, and others.

• Novartis presented efficacy and safety results of REMIX-1 and REMIX-2. Remibrutinib demonstrated greater efficacy as compared to placebo, independent of prior exposure to anti-IgE biologics, in patients with CSU, with a favorable safety profile in both subgroups.
• Celldex Therapeutics announced Top Line results from a Phase II trial in Chronic Spontaneous Urticaria patients’ refractory to antihistamines, including patients with prior biologic experience. The study achieved its primary endpoint. Barzolvolimab administered at 150mg every 4 weeks and 300mg every 8 weeks showed a significant and meaningful improvement in Urticaria Activity Score over 7 days (UAS7) compared to the placebo after 12 weeks in patients suffering from Chronic Spontaneous Urticaria who were unresponsive to antihistamine treatment.
• Sanofi presented the results of the RILECSU study carried out for the treatment of Chronic Spontaneous Urticaria in patients who remain symptomatic despite the use of h1 antihistamine. The initial phase of the RILECSU dose-ranging investigation in adults experiencing moderate to severe Chronic Spontaneous Urticaria exhibited effectiveness and swift onset of action with rilzabrutinib at a dosage of 400mg three times a day (TID). Rilzabrutinib also displayed a positive safety profile.
• Hangzhou Highlightll Pharmaceuticals announced the safety and efficacy results of TLL-018. The drug was well tolerated and showed high efficacy in moderate-to-severe Chronic Spontaneous Urticaria patients with inadequate response to high doses or a combination of antihistamine treatment.
• Tezepelumab, a monoclonal antibody inhibiting thymic stromal lymphopoietin (TSLP), demonstrated continued reductions in Chronic Spontaneous Urticaria disease activity and biomarkers after treatment discontinuation in anti-IgE–naive patients.
• Novartis presented the results of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201.

Hereditary Angioedema (HAE) Highlights

Key pharma companies involved in presenting Hereditary Angioedema data readouts during the recent AAAAI conference are KalVista, Pharvaris and others.

• Sebetralstat, a novel oral plasma kallikrein inhibitor for on-demand treatment in hereditary angioedema was evaluated in the KONFIDENT trial. This Phase III trial was the largest and most representative trial ever conducted in Hereditary Angioedema. The results showed that most patients given sebetralstat at either dose started experiencing symptom relief within two hours. Specifically, the median time to the beginning of symptom relief was 1.61 hours at the lower dose and 1.79 hours at the higher dose. KalVista plans to file for approval of the drug in the US, Japan and Europe this year.
• The integrated safety and efficacy results across Phase II, pivotal Phase III, and open-label extension (OLE) studies evaluating garadacimab (anti-activated factor XII monoclonal antibody) for hereditary angioedema prophylaxis were reported in the AAAAI 2024 conference. These results provides additional support for the strong effectiveness of garadacimab over a period exceeding one year for the prevention of hereditary angioedema in the long term, along with the favorable and consistent safety profile observed thus far.
• Positive results from the CHAPTER-1 Phase II Study of Deucrictibant for the prophylactic treatment of Hereditary Angioedema Attacks were presented at AAAAI 2024. Analysis of the primary endpoint revealed that deucrictibant led to a significant reduction in the monthly attack rate by 84.5% for participants receiving a daily dose of 40 mg and by 79.3% for those receiving a daily dose of 20 mg, compared to the placebo group. These results support the future development of deucrictibant, which could become the preferred option to both treat and prevent Hereditary Angioedema attacks.

Allergy Highlights

Key pharma companies involved in presenting allergy data readouts during the recent AAAAI conference are InnoUp Farma, ARS Pharma and others.

• INP20 demonstrated its potential as an immunotherapy with immunostimulatory capacity as per the results presented at the AAAAI 2024 conference. INP20 exhibited strong activation of cells transfected with TLR2 and TLR4, with both receptors being synergistically activated in a highly potent manner.
• Neffy’s efficacy results of a Phase III trial carried out in patients who developed anaphylactic symptoms after oral food challenge (OFC) were presented at the AAAAI 2024 conference. Neffy, an epinephrine nasal spray, is in development as a needle-free alternative for treating severe allergic reactions. It possesses pharmacokinetic and pharmacodynamic profiles similar to approved epinephrine injection products. ARS Pharma, the developer of Neffy, is scheduled to release top-line findings from its repeat dose investigation of neffy under nasal allergen challenge circumstances in the initial quarter of 2024. It plans to resubmit its New Drug Application (NDA) around the middle of the first half of 2024. Following approval, the expected Prescription Drug User Fee Act (PDUFA) action date and subsequent launch in the United States are anticipated to occur in the middle of the second half of 2024.

For more insights on these results and major breakthroughs from the global healthcare conference, you can visit the link: Healthcare Congress Intelligence And Conference Coverage