Drugs / SOL-116
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05576012 | Oct 2022 → Nov 2024 | rheumatoid arthritis | Lipum AB | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-06 | Lipum AB | Results Lipum Announces Peer-Reviewed Publication of Positive First-in-Human Phase I Results for SOL-116 lipum.se ↗
The randomised, double-blind, placebo-controlled trial (NCT05576012) evaluated subcutaneous SOL-116 in 56 participants – 48 healthy volunteers and 8 patients with mild RA. |
| 2025-10-30 | Lipum AB | Results Lipum presents new topline data supporting BSSL’s role in rheumatoid arthritis lipum.se ↗
The results strengthen the rationale for Lipum’s lead candidate, SOL-116, a first-in-class humanized antibody designed to neutralize BSSL and reduce chronic inflammation in RA. |
| 2025-04-24 | Lipum AB | Results Lipum AB – interim report Q1 for the period January-March 2025 lipum.se ↗
Lipum has completed the Phase I study with SOL-116 and is sharing the top-line results |
| 2025-04-11 | Lipum AB | Results Lipum Announces Successful Completion of Phase I Trial for SOL-116 – Supporting Continued Clinical Development lipum.se ↗
Favorable safety profile: SOL-116 was well tolerated across all dose levels, with no serious adverse events deemed related to the investigational drug. |
| 2025-02-26 | Lipum AB | Results Lipum AB – Year-end report 2024 lipum.se ↗
Over the past year, we have successfully enrolled all subjects and patients in our Phase I study, and we are now able to present the first results. |
| 2025-02-25 | Lipum AB | Results Lipum has successfully completed the phase I study with SOL-116 lipum.se ↗
The study confirmed SOL-116’s favourable safety, tolerability, and predictable pharmacokinetics, supporting a once-monthly dosing regimen. |
| 2024-11-18 | Lipum AB | Results Lipum Presents Promising Data on Novel Antibody SOL-116 at ACR 2024 lipum.se ↗
Lipum AB (publ), a Swedish biopharmaceutical company focusing on innovative treatments for chronic inflammatory diseases, presented positive findings from its first-in-human clinical trial of SOL-116 at the American College of Rheumatology (ACR) Annual Meeting 2024. |
| 2024-06-18 | Lipum AB | Results LIPUM REPORTS FURTHER PROGRESS WHERE THE MULTIPLE DOSE PART OF THE PHASE I CLINICAL STUDY IS COMPLETED lipum.se ↗
Interim analysis of the multiple dose part show that subjects had few adverse events and there was no serious adverse event in subjects administered SOL-116. |
| 2024-01-29 | Lipum AB | Results Lipum reports positive interim results from clinical phase 1 study showing that SOL-116 reduces plasma BSSL levels in healthy subjects lipum.se ↗
Lipum AB (publ) announces that the first part of the clinical phase 1 study, where healthy subjects received a single dose of the drug candidate SOL-116, has been completed with positive results. |
| 2023-03-23 | Lipum AB | Results Lipum’s ongoing clinical phase 1 study proceeds as planned lipum.se ↗
After a fourth dose escalation, a safety evaluation has now been conducted and as expected, data show that SOL-116 remains safe and well tolerated. |
| 2022-09-27 | Lipum AB | Regulatory Lipum gets approval to start Phase 1 clinical trial with drug candidate SOL-116 lipum.se ↗
Lipum AB (publ) announces today that the CTA (clinical trial application) for the drug candidate SOL-116 has been approved by the regulatory authorities in The Netherlands. |
All press releases naming this drug 21 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SOL-116 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05576012 ↗ |
| Modality | Monoclonal antibody | “first-in-class humanised IgG4 monoclonal antibody targeting BSSL” PMID 42331396 ↗ Jun 2026 |
| Route | Subcutaneous | “subcutaneously administered SOL-116” PMID 42331396 ↗ Jun 2026 |