A Randomized, Double-blind, Placebo-controled, Phase 2a Trial Evaluating the Safety and Initial Efficacy of Resomelagon in Patients With Dengue Infection

The goal of this clinical trial is to understand if Resomelagon can treat adult patients with Dengue virus infection. The main questions the investigators aim to answer are:
Is Resomelagon safe to use in patients with Dengue? Is Resomelagon able to reduce the duration of illness? (defined by clinical and laboratory criteria) Participants will be allocated to Resomelagon or placebo groups in this study and asked to take the medication and submitted to blood tests.

开始日期2026-02-01

申办/合作机构

Universidade Federal de Minas Gerais

CTIS2024-514981-37-00

/ Active, not recruiting临床2期

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.

开始日期2024-12-05

申办/合作机构

SynAct Pharma ApS

NCT06671054

/ Recruiting临床2期

A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy and Safety of Oral AP1189 Administered at the Doses of 40, 70, or 100 mg for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Participants With Early Rheumatoid Arthritis and Active Inflammation.

The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.

开始日期2024-10-01

申办/合作机构

SynAct Pharma ApS

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100 项与 Resomelagon 相关的临床结果

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100 项与 Resomelagon 相关的转化医学

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100 项与 Resomelagon 相关的专利（医药）

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项与 Resomelagon 相关的文献（医药）

2025-11-01·PHYTOMEDICINE

Baicalin ameliorates high-fat diet induced MAFLD by inhibiting ERK/PPARγ/CD36 pathway

Article

作者: Xu, Xiaona ; Liu, Hanqiang ; Gao, Peipei ; Su, Zheng ; Wang, Xiaohui ; Li, Yuting ; Li, Mengying ; Zhang, Xianjiao ; Zhang, Lei ; Lei, Jiamin

OBJECTIVE:

Metabolic dysfunction-associated fatty liver disease (MAFLD) is a global health concern with limited therapeutic options. Baicalin (BA), a natural flavonoid, has shown promise in ameliorating lipid metabolism and liver function. This study employed an integrated strategy combining network pharmacology, molecular docking, and in vivo/in vitro validation to elucidate the novel protective mechanism of BA against MAFLD through modulation of the ERK/PPARγ/CD36 signaling axis in high-fat diet (HFD)-induced mice.

METHODS:

Potential targets of BA and MAFLD were identified from multiple databases, with common targets screened via Venn analysis. A protein-protein interaction (PPI) network was constructed and visualized based on degree values. Gene Ontology (GO) and KEGG pathway enrichment analyses were conducted using R software. Molecular docking and surface plasmon resonance (SPR) experiments were performed to evaluate the binding affinity of BA to key targets, and a positive control was also added. For the in vivo study, MAFLD was induced in mice via 16-week HFD. Body weight, average food intake, glucose metabolism (GTT, ITT), serum lipid metabolism indexes (TG, TC, HDL-C, LDL-C), and serum liver function markers (ALT, AST, ALP, GGT) were assessed. Hepatic lipid deposition was analyzed using H&E, oil red O staining and NAS score. The protein and mRNA expression of p-ERK, PPARγ, CD36, SREBP-1c, FAS, ACC, and SCD1 were examined by Western blot or RT-PCR, with CD36 expression was further confirmed by immunofluorescence. In vitro, cell viability was measured using CCK8 at 12, 24, and 48 h after BA treatment. LO2 cells were treated with BA, free fatty acids (FFA), SCH772984 (a p-ERK inhibitor), or resomelagon (a p-ERK agonist), and lipid accumulation and protein expression were evaluated using Western blot and oil red O staining.

RESULTS:

Network pharmacology analysis identified 37 common targets between BA and MAFLD, with PPARγ confirmed as a high-affinity BA target by molecular docking (pKi = -11.6096 µM) and SPR (K_D = 6.84 × 10^-7 M). In vivo, BA significantly reduced body weight (p < 0.05) and improved glucose metabolism (p < 0.05), lowered serum TG, TC, LDL-C levels (p < 0.05) and pro-inflammatory cytokines IL-1β, IL-6, TNF-α levels (p < 0.05). Additionally, BA attenuated hepatic steatosis and downregulated the expression levels of p-ERK, PPARγ and CD36 in liver tissues (p < 0.05). In vitro, BA or SCH772984 inhibited p-ERK, PPARγ, and CD36 expression (p < 0.05), as well as lipid accumulation in FFA-treated LO2 cells (p < 0.05). The resomelagon-treated cells were consistent with the effect of FFA, while BA could reverse the effects (p < 0.05).

CONCLUSION:

This study by using integrates computational prediction demonstrated that PPARγ was the main target of BA, then with multi-level experimental validation, elucidated that BA could ameliorate MAFLD by modulating core ERK/PPARγ/CD36 signaling pathway, highlighting a novel therapeutic target for MAFLD.

2024-12-01·British Journal of Pharmacology

Effects of a pro‐resolving drug in COVID‐19: preclinical studies to a randomized, placebo‐controlled, phase Ib/IIa trial in hospitalized patients

Article

作者: Silva, Barbara L. V. ; Costa, Vivian V. ; Almeida, Pedro R. J. ; Milhorato, Larissa B. ; Queiroz‐Junior, Celso M. ; Jonassen, Thomas E. N. ; Teixeira, Danielle C. ; Teixeira, Mauro M. ; Periard, Alexandre M. ; Fonseca, Talita C. M. ; Tana, Fernanda L. ; Perretti, Mauro ; Avila, Renata E. ; Serufo, Angela V. ; Alcantara, Katlen M. M. ; Resende, Carolina B. ; Santos, Felipe R. ; Souza, Renan P.

Introduction:

Pro‐resolving molecules may curb disease caused by viruses without altering the capacity of the host to deal with infection. AP1189 is a melanocortin receptor‐biased agonist endowed with pro‐resolving and anti‐inflammatory activity. We evaluated the preclinical and early clinical effects of treatment with AP1189 in the context of COVID‐19.

Methods:

C57BL/6j mice were infected intranasally with MHV‐A59 or hK18‐ACE2 mice with SARS‐CoV‐2. AP1189 (10 mg·kg−1, BID, s.c.) was given to the animals from day 2 and parameters evaluated at day 5. Human PBMCs from health donors were infected with SARS‐CoV‐2 in presence or absence of AP1189 and production of cytokines quantified. In the clinical study, 6 patients were initially given AP1189 (100 mg daily for 14 days) and this was followed by a randomized (2:1), placebo‐controlled, double‐blind trial that enrolled 54 hospitalized COVID‐19 patients needing oxygen support. The primary outcome was the time in days until respiratory recovery, defined as a SpO2 ≥ 93% in ambient air.

Results:

Treatment with AP1189 attenuated pulmonary inflammation in mice infected with MHV‐A59 or SARS‐CoV‐2 and decreased the release of CXCL10, TNF‐α and IL‐1β by human PBMCs. Hospitalized COVID‐19 patients already taking glucocorticoids took a median time of 6 days until respiratory recovery when given placebo versus 4 days when taking AP1189 (P = 0.017).

Conclusion:

Treatment with AP1189 was associated with less disease caused by beta‐coronavirus infection both in mice and in humans. This is the first demonstration of the effects of a pro‐resolving molecule in the context of severe infection in humans.

2015-04-01·Journal of immunology (Baltimore, Md. : 1950)2区 · 医学

Biased Agonism as a Novel Strategy To Harness the Proresolving Properties of Melanocortin Receptors without Eliciting Melanogenic Effects

2区 · 医学

Article

作者: Gobbetti, Thomas ; Perretti, Mauro ; Jonassen, Thomas E N ; Montero-Melendez, Trinidad ; Cooray, Sadani N

Abstract:

There is a need for novel approaches to control pathologies with overexuberant inflammatory reactions. Targeting melanocortin (MC) receptors represents a promising therapy for obesity and chronic inflammation, but lack of selectivity and safety concerns limit development. A new way to increase selectivity of biological effects entails the identification of biased agonists. In this study, we characterize the small molecule AP1189 as a biased agonist at receptors MC1 and MC3. Although not provoking canonical cAMP generation, AP1189 addition to MC1 or MC3, but not empty vector, transfected HEK293 cells caused ERK1/2 phosphorylation, a signaling responsible for the proefferocytic effect evoked in mouse primary macrophages. Added to macrophage cultures, AP1189 reduced cytokine release, an effect reliant on both MC1 and MC3 as evident from the use of Mc1r−/− and Mc3r−/− macrophages. No melanogenesis was induced by AP1189 in B16-F10 melanocytes. In vivo, oral AP1189 elicited anti-inflammatory actions in peritonitis and, upon administration at the peak of inflammation, accelerated the resolution phase by ∼3-fold. Finally, given the clinical efficacy of adrenocorticotropin in joint diseases, AP1189 was tested in experimental inflammatory arthritis, where this biased agonist afforded significant reduction of macroscopic and histological parameters of joint disruption. These proof-of-concept analyses with AP1189, an active oral anti-inflammatory and resolution-promoting compound, indicate that biased agonism at MC receptors is an innovative, viable approach to yield novel anti-inflammatory molecules endowed with a more favorable safety profile.

项与 Resomelagon 相关的新闻（医药）

2026-02-18

·synactpharma.com

SynAct Pharma Year-end Report 2025

SynAct Pharma AB (publ) (“SynAct”) today announced its Year-end Report 2025 “As we close the fourth quarter and conclude 2025, I am pleased with the steady progress SynAct Pharma has made across clinical execution, corporate development and external validation. Our focus remains firmly on advancing resomelagon (AP1189), our potential first-in-class non-suppressive therapy for inflammatory diseases, toward meaningful clinical and strategic value creation.” Jeppe ØvlesenChief Executive Officer and Board Member Fourth quarter 2025 (October – December) The Group’s net sales amounted to SEK 0 (0) thousand. Operating expenses amounted to SEK 22,720 (20,797) thousand, an increase of 9%. The Group’s loss after tax amounted to SEK 22,929 (18,379) thousand. The Group’s earnings per share before and after dilution amounted to -0.43 (-0.44) SEK. Cash flow from operating activities amounted to SEK -23,965 (-17,779) thousand. Cash flow from financing activities amounted to SEK -147 (40,199) thousand. Cash flow for the period amounted to SEK -24,112 (22,420) thousand. Cash and cash equivalents at the end of the period amounted to SEK 53,405 (61,209) thousand. Twelve months 2025 (January – December) The Group’s net sales amounted to SEK 0 (0) thousand. Operating expenses amounted to SEK 116,540 (89,980) thousand, an increase of 29%. The Group’s loss after tax amounted to SEK 110,826 (82,401) thousand. The Group’s earnings per share before and after dilution amounted to -2.17 (-2.08) SEK. Cash flow from operating activities amounted to SEK -97,330 (89,197) thousand. Cash flow from financing activities amounted to SEK 90,458 (87,405) thousand. Cash flow for the period amounted to SEK -6,872 (-1,792) thousand. Significant events during the fourth quarter Oct 29 – Notice of Extraordinary General Meeting of SynAct Pharma AB on November 27, 2025. Nov 3 – 190 patients randomized in SynAct Pharma’s Phase 2b study ADVANCE. Nov 27 – Report from the Extraordinary General Meeting of SynAct Pharma AB. Dec 11 – Nomination committee appointed ahead of AGM 2026 in SynAct Pharma AB. Dec 22 – SynAct Pharma management and Chairman of the Board have acquired shares. Dec 23 – SynAct Pharma Board of Directors and Management Enter Lock-up Agreements. Significant events after the end of the period Jan 9 – The Board of Directors of SynAct Pharma AB (publ) has resolved on the repurchase of own shares. Jan 19 – SynAct Pharma appoints Malin Wikstrand as interim CFO. Jan 30 – SynAct Pharma initiates Phase 2 study in respiratory insufficiency. Feb 6 – SynAct Pharma announces that recruitment goal was reached in the Phase 2b ADVANCE study. Feb 17 – Repurchase of shares in Synact Pharma AB. For further information about SynAct Pharma AB, please contact:Jeppe ØvelsenCEO, SynAct Pharma ABPhone: +45 28 44 75 67 E-mail: joo@synactpharma.com Malin Wikstrand Interim CFO, SynAct Pharma AB Phone: +46 735-045760E-mail: MAW@synactpharma.com About SynAct Pharma ABSynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For further information: https://synactpharma.com/. This information is information that SynAct Pharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-02-18 07:30 CET. AttachmentsSynAct Pharma Q4 2025 Interim Report

高管变更财报临床2期

2026-01-30

·synactpharma.com

SynAct Pharma initiates Phase 2 study in respiratory insufficiency

SynAct Pharma AB (publ) (”SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnological company focused on treating inflammation through resolution therapy, today announced that it has initiated a Phase 2 study (RESPIRE) with resomelagon in patients hospitalized with respiratory insufficiency due to viral infections. The SynAct-CS009-RESPIRE study has been approved and the first visit of a study participant is expected in Q1 2026. Thus, SynAct Pharma is executing on its dual strategy for resomelagon by progressing the development in host-directed therapy in viral infections alongside development in its lead indication in RA and other autoimmune diseases. “With the respiratory viral season hitting Europe it’s critical to test resomelagon as a safe and effective therapy to avoid the potential devastating consequences of respiratory insufficiency leading to hospitalizations of millions of people in Europe and the U.S. annually,” said Thomas Jonassen, Chief Scientific Officer of SynAct Pharma. “The Phase 2 RESPIRE trial builds on convincing results in Covid-19 patients1 showing faster recovery with fewer days in hospital and intensive care needs, and results from influenza models2 showing that resomelagon had significant treatment effects including prevention of mortality. In this new study, we want to demonstrate a reduction in events leading to intensive unit care and prolonged hospitalization.” The study is a randomized, double-blind, multicenter, placebo-controlled study enrolling 96 patients. The study population will consist of hospitalized participants with respiratory insufficiency expected to be caused by respiratory viral infection. “This opportunity is a significant expansion of the potential use of resomelagon in the hospital setting”, said Mads Bjerregaard, Chief Business Officer of SynAct Pharma. “By executing on our dual development strategy, we are also expanding on our discussions with partners driving innovation in the hospital business.” About hyperinflammation from respiratory viral infections: Respiratory viral infections include Influenza, Covid-19, and RSV, which are the most common respiratory viral infections leading to an estimated two million people hospitalized annually in Europe and the U.S.3 Respiratory viral infections may worsen to a condition involving hyperinflammation in the respiratory system that renders the patient unable to provide enough oxygen to the body. Consequently, the patient would need to go to a hospital to get adequate treatment including oxygen therapy. If symptoms worsen, the patient may experience acute respiratory distress syndrome (ARDS) and require escalating oxygen support or mechanical ventilation. Current treatments rely largely on supportive care and immunomodulators—such as corticosteroids (e.g., dexamethasone), IL-6 receptor blockers (e.g., tocilizumab), and JAK inhibitors (e.g. baricitinib) – which mitigate inflammation but carry risks of immunosuppression or unwanted adverse effects, highlighting the need for resolution-based therapies that clear the inflammation without dampening host defense. Resomelagon has been shown to induce a relative shift in the phenotype of macrophages (MACs) from pro-inflammatory TYPE 1 alike MACs to type 2 alike proresolving MACs and in parallel modulate the recruitment of polymorph nuclear cells. These effects induce a new setpoint for the hyperinflammatory state in the patients. Consequently, resomelagon has the potential to boost the pro-resolving capabilities of the patient’s immune system to safely maintain the elevated inflammation needed to fight the viral infection and facilitate the system’s return to a healthy state. About the SynAct-CS009-RESPIRE study: A randomized, double-blind, multicentre, placebo-controlled study with repeated once daily doses of AP1189/placebo. The study population will consist of hospitalized participants with respiratory insufficiency expected to be caused by respiratory viral infection. The study is to include male and female participants, 18 years and older, with expected respiratory viral infection, and positive for either SARS-COV-2, Influenza A or B, or RSV on bedside LAF test. Symptomatic participants needing respiratory support, as defined by Saturation of O2 ≤ 93% at ambient air or requiring significantly greater FiO2 to maintain SpO2 > 93% (i.e., need for supplementary oxygen supply by a nasal catheter or facial mask), and who agrees to participate in the study. The investigational product treatment will be maintained for 14 days during the hospital stay. If participants are discharged before day 14, they should continue with the treatment at home. The treatment effects of resomelagon versus placebo will be evaluated from baseline to day 28 on the composite endpoint: Occurrence of any one of the following: Death; Invasive mechanical ventilation; Extracorporeal Membrane Oxygenation (ECMO); Cardiovascular organ support (balloon pump or inotropes/vasopressors); or Renal failure (Cockcroft-Gault estimated creatinine clearance <15 ml/min), hemofiltration or dialysis. References: Almeida et al., Br J Pharmacol. 2024;1–16. Effects of a pro-resolving drug in COVID-19: preclinical studies to a randomized, placebo-controlled, phase Ib/IIa trial in hospitalized patients. Data on file. Pre-clinical model of influenza. CDC.gov; RESP-NET for U.S.; company estimate for Europe For further information, please contact:Jeppe ØvlesenCEO, SynAct Pharma ABPhone: + 45 2844 7567E-mail: investor.relations@synactpharma.com About SynAct Pharma ABSynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For further information: https://synactpharma.com/. AttachmentsSynAct Pharma initiates Phase 2 study in respiratory insufficiency

临床2期

2025-11-03

·synactpharma.com

Resomelagon Phase-2B ADVANCE Study Update: 190 Patients Randomized Tracking for Year-End Recruitment Completion

SynAct Pharma AB (publ) (”SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnological company focused on treating inflammation through resolution therapy, has randomized 190 out of 240 patients and is on-track on lead program Phase 2b study. “Since summer we have established good momentum in recruitment,” said Thomas Jonassen, Chief Science Officer of SynAct Pharma. The Phase 2b ADVANCE is a 12-week randomized placebo-controlled study including newly diagnosed patients with Rheumatoid Arthritis, with elevated inflammation levels (CRP levels above 3mg/l), severe disease symptoms, and ready to initiate 1st line methotrexate therapy. Thomas Jonassen continues, “Rheumatoid Arthritis affects 18 million people and is expected to affect up to 32 million people by 2050 (ref. 1). About 50% of patients present with moderate to severe disease scores at time of diagnosis (ref. 2) and major medical societies recommend progressive treatment to prevent disease from progressing. Resomelagon in addition to 1st line methotrexate therapy may be a safe and effective way to reduce disease symptoms and may prolong or prevent the need for additional therapy typically adding glucocoid steriods and biologic DMARDS.” References: 1) Lancet Rheumatol 2023;5: e594–610; 2) Z Rheumatol. 2017 Jun;76(5):434-442 For further information, please contact:Jeppe ØvlesenCEO, SynAct Pharma ABPhone: + 45 2844 7567E-mail: investor.relations@synactpharma.com About SynAct Pharma ABSynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For further information: https://www.synactpharma.com/. AttachmentsResomelagon Phase-2B ADVANCE Study Update: 190 Patients Randomized Tracking for Year-End Recruitment Completion

临床2期临床结果

100 项与 Resomelagon 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
炎症	临床2期	美国	SynAct Pharma ApS	2024-10-01
炎症	临床2期	保加利亚	SynAct Pharma ApS	2024-10-01
炎症	临床2期	丹麦	SynAct Pharma ApS	2024-10-01
炎症	临床2期	摩尔多瓦	SynAct Pharma ApS	2024-10-01
炎症	临床2期	波兰	SynAct Pharma ApS	2024-10-01
成人呼吸窘迫综合征	临床2期	瑞典	SynAct Pharma ApS	2022-01-30
特发性膜性肾病	临床2期	丹麦	SynAct Pharma ApS	2020-08-31
特发性膜性肾病	临床2期	瑞典	SynAct Pharma ApS	2020-08-31
婴儿期发病的多系统疾病（神经系统、内分泌系统和胰腺系统疾病）	临床2期	丹麦	SynAct Pharma ApS	2020-08-31
肾病综合征	临床2期	丹麦	SynAct Pharma ApS	2020-08-31

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04004429 (BEGIN, CTgov)	临床2期	类风湿关节炎	105	50 mg AP1189 (50 mg AP1189)	鬱餘鏇簾醖鹽糧膚觸窪 = 網壓獵遞鏇製選壓獵鬱衊鏇鏇蓋製鏇壓餘壓餘 (製鏇夢壓糧衊衊壓遞夢, 衊襯簾範餘積艱選齋鬱 ~ 顧壓艱築艱積願獵壓壓) 更多	-	2024-07-10
				AP1189 (100 mg AP1189)	鬱餘鏇簾醖鹽糧膚觸窪 = 糧製蓋糧鏇壓築觸鏇艱衊鏇鏇蓋製鏇壓餘壓餘 (製鏇夢壓糧衊衊壓遞夢, 艱壓築願構蓋艱顧齋簾 ~ 獵構鹽衊鏇鏇衊築鑰齋) 更多
NCT05516979 (EXPAND，SynAct-CS007, NEWS 1 \| NEWS 2)	临床2期	类风湿关节炎	55	Resomelagon	獵膚襯構襯簾糧膚窪壓(醖願醖製鑰艱鑰襯鑰鏇) = 構鏇壓壓齋簾憲憲齋築觸獵鹹鹹糧餘鬱鹹簾顧 (鹽淵範壓製膚願繭鑰醖 ) 更多	积极	2024-02-22
				安慰剂	獵膚襯構襯簾糧膚窪壓(醖願醖製鑰艱鑰襯鑰鏇) = 構獵蓋範鹹鏇範繭壓構觸獵鹹鹹糧餘鬱鹹簾顧 (鹽淵範壓製膚願繭鑰醖 ) 更多
NCT05516979 (EXPAND，SynAct-CS007, ACR2023 \| NEWS)	临床2期	类风湿关节炎	127	Resomelagon	餘衊鹽鏇廠蓋選顧選鏇(窪膚製窪遞鹹衊網廠齋) = 壓膚獵餘選鹹遞鑰衊範獵獵艱遞糧憲衊鑰選鬱 (範願壓壓顧鬱鬱製窪糧 )	不佳	2023-09-04
				安慰剂	餘衊鹽鏇廠蓋選顧選鏇(窪膚製窪遞鹹衊網廠齋) = 夢獵襯鏇膚觸壓網顧積獵獵艱遞糧憲衊鑰選鬱 (範願壓壓顧鬱鬱製窪糧 )