LP-003 / Longbio Pharma - LARVOL DELTA

Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Longbio Pharma

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Longbio Pharma

New P2 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3 | N=546 | Active, not recruiting | Sponsor: Longbio Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergic Rhinitis • Immunology • Inflammation

Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3 | N=251 | Recruiting | Sponsor: Longbio Pharma

New P3 trial • Allergic Rhinitis • Immunology • Inflammation

A Study of Single Dose of LP-003 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Longbio Pharma | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult (clinicaltrials.gov) - P2 | N=180 | Completed | Sponsor: Longbio Pharma | Recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Immunology • Inflammation

Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment (clinicaltrials.gov) - P2 | N=202 | Completed | Sponsor: Longbio Pharma | Recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Nov 2025

Trial completion • Trial completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Longbio Pharma | Active, not recruiting ➔ Completed

Trial completion • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study of Single Dose of LP-003 in Adolescent Subjects (clinicaltrials.gov) - P1/2 | N=6 | Not yet recruiting | Sponsor: Longbio Pharma

New P1/2 trial • Allergic Rhinitis • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Urticaria

LP-003, a novel high-affinity anti-IgE antibody for inadequately controlled seasonal allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical trial. (PubMed, Clin Transl Allergy) - "These findings support LP-003 as a promising add-on option to the SoC for patients with moderate to severe SAR. Fixed dosage regimen and extensive suppression of free-IgE render it a cutting-edge advantage."

Clinical • Journal • P2 data • Allergic Rhinitis • Immunology • Inflammation

Breakthrough! Exciting interim Phase II Data of LP-003 in CSU released by Longbio at AAAAI 2025 (PRNewswire) - P2 | N=200 | NCT06228560 | Sponsor: Longbio Pharma | "This is a multi-center, double-blind, placebo-controlled Phase II clinical study, randomized to receive 100 mg Q8W, 200 mg Q8W or 200 mg Q4W of LP-003 or 300mg Omalizumab or placebo (n=40/group)....Comparing to the first-generation anti-IgE antibody, omalizumab, LP-003 shows: superior improvement in mean change of UAS7 from baseline at week 12 as well as the percentage% of patients with UAS7=0 at week 4 and week 12; rapid and sustained relief in CSU symptoms in a dose-dependent manner; favorable safety profile, no statistically significant difference in adverse events were found between LP-003 and placebo groups...In addition, LP-003's efficacy result was also comparable to barzolvolimab without raising any new safety concerns."

P2 data • Chronic Spontaneous Urticaria

An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU (AAAAI-WAO 2025) - "A new anti-IgE antibody, LP-003 developed by Longbio, of even higher IgE binding affinity, stronger FcεRI inhibition and much longer half-life compared to Omalizumab and Ligelizumab, was investigated in refractory CSU patients. Conclusions These interim-analysis results indicated that 200mg Q4W and 200mg Q8W LP-003 demonstrated potentially superior improvement and 100 mg Q8W LP-003 shows non-inferiority compared to Omalizumab group. LP-003 was also well-tolerated with a favorable safety profile."

P2 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study of Single Dose of LP-003 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Longbio Pharma

New P1 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis (EAACI 2024) - "Omalizumab was the only approved anti-IgE antibody for several allergic diseases. In patients with moderate to severe SAR not well controlled despite SoC, LP-003 added to SoC demonstrated better efficacy in improving symptoms and was well tolerated. These results indicate that LP-003 renders a promising therapeutic option for AR."

P2 data • Allergic Rhinitis • Immunology • Inflammation

A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: Longbio Pharma

New P1 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Groundbreaking! Phase II Data of LP-003 Unveiled by Longbio Pharma at AAAAI2024 (PRNewswire) - "Longbio Pharma...proudly announced the release of preliminary Phase II data for LP-003, the new generation anti-IgE antibody, at the 2024 American Academy of Allergy, Asthma & Immunology annual meeting (AAAAI 2024)....The presentation of the poster titled 'A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis' by Longbio Pharma marked a significant moment during the conference."

P2 data • Allergic Rhinitis • Immunology

A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis (AAAAI 2024) - "Omalizumab was the only approved anti-IgE antibody for several allergic diseases. In patients with moderate to severe AR, LP-003 added to SoC demonstrated better efficacy in improving symptoms and was well tolerated. These results indicate that LP-003 renders a promising therapeutic option for AR."

P2 data • Allergic Rhinitis • Allergy • Immunology • Inflammation

Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Longbio Pharma

New P2 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Longbio Pharma Presented Positive Topline Phase 1 Results for LP-003 at JSA2023 (Yahoo Finance) - P1 | N=32 | "Longbio Pharma...oral presented the phase I data of LP-003 (new generation of anti-IgE antibody) at the 72nd Annual Meeting of The Japanese Society of Allergology (JSA2023)....LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 46.3 days to 75.6 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 70 days at 1 mg/kg group (except one with high baseline IgE level) to 10 mg/kg group. LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement....Two phase II study, with indication of allergic rhinitis or chronic spontaneous urticaria, are on-going. The company expects to have the topline result for LP-003 Phase II study by the end of 2023."

P1 data • P2 data • Allergic Rhinitis • Allergy • Chronic Spontaneous Urticaria • Immunology • Urticaria

Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Longbio Pharma

New P2 trial • Allergic Rhinitis • Immunology • Inflammation

Longbio Pharma Presented Positive Topline Phase 1 Results for LP-003 at ERS2023 (PRNewswire) - P1 | N=32 | CTR20221413 | "Longbio Pharma (Suzhou) Co., Ltd...announced the preliminary phase I data of LP-003 (new generation of anti-IgE antibody) at the 29th Congress of European Rhinologic Society...LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 46.3 days to 75.6 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 70 days at 1 mg/Kg group (except one with high baseline IgE level) to 10 mg/Kg group...LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement...'The positive results reinforce our belief in the best-in-class potential of LP-003 and its ability to address the urgent needs of patients suffering from allergic diseases, like allergic rhinitis.'....The company expects to have the topline result for LP-003 Phase II study by the end of 2023."

P1 data • P2 data • Allergic Rhinitis • Allergy • Immunology