SOL-116 / Lipum - LARVOL DELTA

Lipum publishes positive Phase I results for SOL-116 (BioStock) - "The randomized, double-blind, placebo-controlled study (NCT05576012) included 56 participants – 48 healthy volunteers and 8 patients with mild RA – who received subcutaneous administration of SOL-116. The results show that the substance was well tolerated at all dose levels tested, with predominantly mild side effects and a low immunogenicity. Exposure increased dose-proportionally and the long half-life is considered to support the possibility of sparse dosing intervals. The study also showed that free circulating BSSL was effectively and sustainably reduced – a result confirming that the antibody actually reaches and binds its target protein...Since then, the company has also secured EUR 5,5 million of a total Horizon Europe grant of EUR 8 million for The BEYOND project, which will finance the planned phase IIa study without shareholder dilution."

First-in-human • New P2a trial • P1 data • Rheumatoid Arthritis

Lipum secures EUR 5,5 million for phase IIa study (BioStock) - "Lipum has signed the grant agreement for the BEYOND project within Horizon Europe, securing EUR 5,5 million of a total project grant of EUR 8 million. The funding will support the continued clinical development of SOL-116, including a planned phase IIa proof-of-concept study in rheumatoid arthritis."

Financing • New P2a trial • Rheumatoid Arthritis

First-in-human (phase I) trial of SOL-116, a humanised IgG4 monoclonal antibody targeting bile salt-stimulated lipase, in healthy participants and rheumatoid arthritis patients. (PubMed, RMD Open) - P1 | "This study demonstrated that SOL-116 has a favourable safety and PK profile. Combined with effective reduction of free BSSL in the circulation, findings in this study support ongoing clinical development of SOL-116, with a focus on elucidating the efficacy and mechanism of action of BSSL in the treatment of chronic inflammation, primarily RA."

First-in-human • Journal • P1 data • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

First-in-human (Phase I) trial of SOL-116, a humanized IgG4 monoclonal antibody targeting bile salt-stimulated lipase, in healthy participants and rheumatoid arthritis patients. (EULAR 2026) - "Conclusions This study demonstrated that SOL-116 has a favorable safety and PK profile. Combined with effective reduction of free BSSL in the circulation, findings in this study support ongoing clinical development of SOL-116, with a focus on elucidating the efficacy and mechanism of action of BSSL in the treatment of chronic inflammation, primarily RA."

Clinical • First-in-human • P1 data • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Flerie and Lipum have agreed on a merger plan (Nasdaq) - "The purpose of the merger is to establish the conditions necessary to continue financing Lipum’s operations....SOL-116 will now advance into a Phase 2 study, in which Lipum intends to evaluate treatment efficacy in patients with moderate to severe rheumatoid arthritis (RA). To initiate the Phase 2 study, the principal remaining requirements relate to financing for CRO collaboration and study execution."

Financing • New P2 trial • Immunology • Rheumatoid Arthritis

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