BBT001 / Bambusa Therapeutics - LARVOL DELTA

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT001, a Novel Bispecific IL-4Rα/IL-31 Antibody: Phase 1 Single-Ascending-Dose Study Results in Healthy Volunteers (ISDS 2025) - P1 | "BBT001 was well tolerated up to 1200 mg with no DLTs, and demonstrated prolonged half-life with rapid, potent, and durable target engagement. These results support advancing BBT001 into MAD and evaluation in patients with moderate-to-severe AD."

Clinical • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL4

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: Bambusa Therapeutics

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=198 | Recruiting | Sponsor: Bambusa Therapeutics | N=98 ➔ 198

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT001, a Novel Bispecific IL-4Rα/IL-31 Antibody: Results from the Single-Ascending Dose Portion of a Double-Blind, Placebo-Controlled Phase I Study in Healthy Volunteers and Patients with A (ISAD-RAJKA 2025) - P1 | "BBT001 was well tolerated at all doses with no DLTs, and demonstrated prolonged half-life with rapid, potent and durable target engagement. These results support advancing BBT001 into MAD and evaluation in patients with moderate-to-severe AD."

Clinical • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL4

…Bambusa Therapeutics unveiled highly positive results from the single ascending dose portion of its ongoing Phase I healthy volunteer study of BBT001 at the European Academy of Dermatology and Venereology (EADV) 2025 (PRNewswire-Asia) - "The data demonstrated:...Rapid, complete, and sustained IL-4Rα binding and pSTAT6 inhibition observed through Week 8+ following a single dose of BBT001. An unprecedented, dose-dependent, rapid, deep, and sustained reduction in TARC levels after a single dose of BBT001, with potent suppression maintained through Week 8+."

P1 data • Atopic Dermatitis

…Bambusa Therapeutics has achieved its next major milestone: the dosing of the first patient with moderate-to-severe atopic dermatitis in the Phase I clinical trial of BBT001 (PRNewswire-Asia)

Trial status • Atopic Dermatitis

Dual Inhibition of IL-4Rα and IL-31 by BBT001: A Novel Tetravalent Bispecific Antibody for Enhanced Atopic Dermatitis Therapy (EADV 2025) - "In OXA- and MC903-induced AD models, BBT001 outperformed dupilumab analog monotherapy in reducing ear thickness. These preclinical findings highlight BBT001's potential to deliver enhanced therapeutic benefit in AD patients by simultaneously targeting inflammatory and pruritic pathways. Its engineered Fc region enables reduced effector function and extended half-life, potentially supporting more convenient dosing. A first-in-human clinical trial is currently underway to evaluate the safety, tolerability, PK and exploratory clinical activity of BBT001 in healthy volunteers and AD patients."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13 • IL31RA • IL4 • OSMR • STAT6

Safety, tolerability, and pharmacokinetic (PK) results from the single-ascending dose (SAD) portion of the Phase 1 study of BBT001—a novel bispecific IL-4Rα/IL-31 antibody—conducted in healthy volunteers and patients with atopic dermatitis (EADV 2025) - P1 | "This Phase 1 SAD study characterizes the safety, tolerability, and PK profile of BBT001 in healthy volunteers. The findings support dose selection and scheduling for subsequent MAD cohorts in healthy individuals and patients with AD, and contribute to the early clinical development profile of BBT001."

Clinical • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13 • IL4

Shanzhuyao Biopharmaceuticals BBT001 starts Phase I clinical trial for moderate to severe atopic dermatitis [Google translation] (Sina Corp) - "Data from the Drug Clinical Trial Registration and Information Disclosure Platform show that a Phase I clinical trial of Shanzhuyao (Beijing) Technology Co., Ltd. has been launched to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and clinical activity of BBT001 in healthy subjects and adult patients with moderate to severe atopic dermatitis. The clinical trial registration number is CTR20252966, and the first public information date is July 25, 2025...The primary endpoints of this trial include the incidence, relevance and severity of adverse events (AEs) graded according to NCI CTCAE v5.0; changes in vital sign measurements, physical examinations, clinical laboratory test results and 12-lead results....Currently, the experiment is in progress (not yet recruited), with a target enrollment of 74 people."

Trial status • Atopic Dermatitis

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Bambusa Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT001, a Novel Multi-Targeting, Half-Life Extended Bispecific Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Skin Diseases (PRNewswire) - "Bambusa Therapeutics...announced the initiation of dosing in healthy volunteers (HV) in its first clinical trial for BBT001, a novel, multi-targeting, half-life extended bispecific antibody, which is being developed initially as a treatment for atopic dermatitis (AD)....The Phase 1 clinical trial (BBT001-001; NCT06808477) is a randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating BBT001 in healthy volunteers and adults with moderate to severe atopic dermatitis. The trial will assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and preliminary clinical activity of BBT001 and is expected to enroll approximately 98 participants across multiple cohorts. Interim safety and pharmacokinetic data are anticipated in the second half of 2025."

P1 data • Trial status • Atopic Dermatitis

Bambusa Therapeutics Raises Approximately $90 Million in Series A Financing to Advance Next-generation Bispecific Antibodies for Immunology & Inflammation Diseases (PRNewswire) - "Bambusa Therapeutics, Inc...today announced the successful completion of its oversubscribed Series A financing of approximately $90 million. The round was led by new investor RA Capital Management, with participation from new investors including Janus Henderson Investors, Redmile Group, Invus, and ADAR1 Capital Management. All existing investors also participated. The funding will support the advancement of Bambusa's lead programs through Phase I trials and drive further pipeline development...Two of Bambusa's four programs are on track to enter the clinic in Q1 2025 and mid-2025, respectively. BBT001...intended to supplant the current standard of care for a range of dermatological conditions. BBT002...created as a 'platform in a molecule' with applications across respiratory, dermatology, and gastroenterology indications...BBT003 and BB004, also have best-in-disease potential in the inflammatory bowel diseases and rheumatological indications."

Financing • New P1 trial • Dermatology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Rheumatology