SOL-116 / Lipum - LARVOL DELTA

Lipum Announces Successful Completion of Phase I Trial for SOL-116 – Supporting Continued Clinical Development (Lipum Press Release) - P1 | N=56 | NCT05576012 | Sponsor: Lipum AB | "Lipum AB (publ) announces the completion and publication of the Clinical Study Report (CSR) for its First-in-Human (FIH) Phase I trial evaluating SOL-116....Favorable safety profile: SOL-116 was well tolerated across all dose levels, with no serious adverse events deemed related to the investigational drug. Predictable pharmacokinetics (PK): Dose-proportional increases in exposure and an average terminal half-life of about 16–21 days support a once-monthly dosing regimen. Low immunogenicity: Anti-drug antibodies (ADA) were detected in only one participant (RA cohort), and the patient reverted to ADA-negative at the subsequent measurement. Confirmed target engagement: Exploratory results demonstrated reduced levels of bile salt-stimulated lipase (BSSL) in participants receiving SOL-116, suggesting direct on-target activity."

P1 data • Rheumatoid Arthritis

Lipum has successfully completed the phase I study with SOL-116 (Lipum Press Release) - P1 | N=56 | NCT05576012 | Sponsor: Lipum AB | "Lipum AB...announces the completion of its phase I clinical trial (LPM-116-001) evaluating SOL-116, with positive results...full Clinical Study Report is expected to be available by the end of March 2025...Key top-line results: Baseline characteristics: Total number of subjects: 56 (SOL-116: 42, Placebo: 14)...Safety and tolerability: SOL-116 was well tolerated at all dose levels tested...Anti-drug antibodies (ADA) were detected in only one of 336 post-dose samples from 56 subjects....The PK analysis showed favourable results that support the possibility of a monthly dosing. SOL-116 had a half-life of approximately 20 days and median Tmax values ranging from 5.1 to 7.2 days across different dose levels. SOL-116 systemic exposures as well as peak exposures (Cmax) demonstrated a dose-proportional increase across the single SC injection dose range of 0.075 to 6.075 mg/kg in healthy subjects."

P1 data • PK/PD data • Trial completion • Rheumatoid Arthritis

First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Lipum AB | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Lipum presents promising phase I data at ACR 2024 (BioStock) - P1 | N=56 | NCT05576012 | Sponsor: Lipum AB | "Lipum will present positive data from the phase I study of its drug candidate SOL-116 at the American College of Rheumatology (ACR) Annual Meeting 2024, a leading global conference in rheumatology. The interim results confirm that SOL-116 demonstrates a favourable safety profile and pharmacokinetics in line with expectations. The study approaches its conclusion, and Lipum plans to share the final report in the first quarter of 2025....Lipum has demonstrated that BSSL is linked to chronic inflammation in diseases such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), and psoriatic arthritis (PsA)....The findings demonstrate that SOL-116 is well-tolerated, with no reported severe adverse effects at any dose level. Pharmacokinetic data aligned with expectations, confirming that SOL-116 is efficiently absorbed and has a half-life of 20 days, supporting a long-lasting therapeutic profile."

P1 data • PK/PD data • Immunology • Psoriatic Arthritis • Rheumatoid Arthritis

A First-in-Human Clinical Trial Evaluating the Safety and Pharmacokinetics of SOL-116, a Novel Humanized Monoclonal Antibody Targeting Bile Salt-Stimulated Lipase for the Treatment of RA (ACR Convergence 2024) - "SOL-116 was well tolerated, with robust and predictable PK and no induction of ADAs following single and multiple dosing in healthy subjects. Single doses of SOL-116 effectively eliminated circulating BSSL. These findings strongly support the continued clinical development of SOL-116."

Clinical • P1 data • PK/PD data • Idiopathic Arthritis • Immunology • Inflammation • Rheumatology

First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Lipum AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Lipum has included first RA patient (BioStock) - "Lipum recently announced that the first patient with rheumatoid arthritis has been included and dosed in ongoing phase I clinical trial with SOL-116 in the Netherlands. Previously, only healthy subjects were included in the study, but now the first patient has received a dose of SOL-116 or placebo....The company has announced positive safety and pharmacokinetic results from the first part of the study – single dose escalation (SAD) in five groups of healthy subjects. The second part includes a group of eight healthy subjects receiving multiple doses of SOL-116, and this part is expected to be completed in March."

Trial completion date • Trial status • Rheumatoid Arthritis

First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Lipum AB | Trial completion date: Mar 2024 ➔ Aug 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Lipum AB | Trial completion date: Aug 2023 ➔ Mar 2024 | Trial primary completion date: Aug 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase) (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Lipum AB | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase) (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Lipum AB

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology