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.

Start Date01 Feb 2026

Sponsor / Collaborator

Universidade Federal de Minas Gerais

CTIS2024-514981-37-00

/ RecruitingPhase 2

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. - CS008

Start Date10 Dec 2024

Sponsor / Collaborator

SynAct Pharma ApS

NCT06671054

/ RecruitingPhase 2

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.

Start Date01 Oct 2024

Sponsor / Collaborator

SynAct Pharma ApS

[+1]

100 Clinical Results associated with Resomelagon

100 Translational Medicine associated with Resomelagon

100 Patents (Medical) associated with Resomelagon

Literatures (Medical) associated with Resomelagon

01 Nov 2025·PHYTOMEDICINE

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

Article

Author: Liu, Hanqiang ; Xu, Xiaona ; 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.

01 Dec 2024·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

Author: 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. ; Avila, Renata E. ; Perretti, Mauro ; 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.

01 Apr 2015·Journal of immunology (Baltimore, Md. : 1950)Q2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: 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.

News (Medical) associated with Resomelagon

27 May 2025

·synactpharma.com

SynAct Pharma publishes Q1 2025 interim results

SynAct Pharma AB (publ) (“SynAct”) today publishes the interim report for the first quarter 2025. “SynAct Pharma has a remarkable drug candidate with resomelagon (AP1189). The data gained so far point to a significant change to how we help the body resolve excessive or chronic inflammation, situations when inflammation can overwhelm the immune system’s ability to counter the inflammation that can lead to suffering, tissue damage and loss of function.” Jeppe Øvlesen, Chief Executive Officer and Board Member First quarter 2025 (January – March) The Group’s net sales amounted to SEK 0 (0) thousand. Operating expenses amounted to SEK 28,098 (25,706) thousand, an increase of 9%. The Group’s loss after tax amounted to SEK 24,684 (24,906) thousand. The Group’s earnings per share before and after dilution amounted to -0.51 (-0.70) SEK. Cash flow from operating activities amounted to SEK -28,826 (-11,189) thousand. Cash flow from financing activities amounted to SEK 19,703 (-154) thousand. Cash flow for the period amounted to SEK -9,123 (-11,343) thousand. Cash and cash equivalents at the end of the period amounted to SEK 51,161 (51,553) thousand. Significant events during the first quarter Jan 9 – SynAct Pharma AB announces outcome of the rights issue and resolves on a directed share issue to guarantors. Jan 31 – Change in number of shares and votes in SynAct Pharma AB. Feb 20 – SynAct’s Nomination Committee proposes Jeppe Ragnar Andersen to the Board. Mar 4 – Pivotal US Patent Protecting resomelagon (AP1189) Granted to SynAct Pharma. Mar 17 – The European Patent Office issues an Intention to Grant a European Patent Covering the Clinical Formulation of resomelagon (AP1189). Significant events after the end of the period Apr 11 – SynAct Pharma Announces Initiation of Phase 2 Study with resomelagon (AP1189) for the Treatment of Patients with Dengue. Apr 23 – SynAct receives Notice of Allowance for grant of US Patent covering resomelagon (AP1189) combination therapy. May 12 – SynAct receives Issue Notification and Patent Term Adjustment for US patent covering resomelagon (AP1189) combination therapy. For further information, please contact: Jeppe Øvlesen, CEO SynAct Pharma Tel: +45 2844 7567 Email: JOO@synactpharma.com About SynAct Pharma AB SynAct Pharma AB (publ) (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on resolving inflammation through 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 anti-inflammatory activity in autoimmune and inflammatory diseases to help patients achieve immune balance and overcome their inflammation. For more information: www.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 2025-05-27 07:30 CEST.

Financial Statement

23 Sep 2024

·synactpharma.com

SynAct initiates the Phase 2b ADVANCE study with resomelagon (AP1189) in the US

SynAct Pharma AB (“SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnology company focused on resolving inflammation through selective activation of the melanocortin system, today announces that the ADVANCE study, a Phase 2b randomized, double-blind placebo controlled clinical multi-center study in patients with newly diagnosed severe rheumatoid arthritis (RA) with the company's lead compound resomelagon (AP1189) actively recruits patients following initiation of sites in the USA. “We are very excited about the perspective of having the ADVANCE study up running in the US. Pending approval in Europe we plan to have active recruitment at more than 20 sites in a total of 7 countries in Q4 2024,” said Thomas Jonassen, CSO at SynAct Pharma. Resomelagon (AP1189) is a biased melanocortin receptor type 1 and 3 agonist that in Phase 2 clinical trials in newly diagnosed RA patients with high disease activity and signs of systemic inflammation showed significant treatment effect compared to placebo treatment with a good safety profile supporting first line treatment with the compound in combination with methotrexate (MTX). The primary aim of the ADVANCE study is to confirm the treatment potential of the compound and to identify optimal doses for Phase 3 development in patients with newly diagnosed RA. “The initiation of the ADVANCE is a cornerstone in the strategy put forward in the spring and we are pleased that the team in in collaboration with our CRO and advisors has been able to execute on the ambitious schedule that was laid out for updating the IND in the US, filing trial applications in Europe as well as managing the complex operations related to initiation of a clinical trial,” said Jeppe Øvlesen, CEO at SynAct Pharma. “We have focused resomelagon as a new innovative oral treatment option in early RA with high disease activity where there is a need for new safe medicines. We strongly believe in resomelagon as a treatment option for these patients as well as for several groups of patients suffering from autoimmune and/or inflammatory disease. Our strategy balances the risks and the opportunities to create most value for the patients, our investors and for our potential partners.” In the ADVANCE study four cohorts of RA patients, diagnosed within 6 months and showing signs of severe RA (DAS28-CRP >5.1; CDAI >22) including signs of systemic inflammation, defined as hsCRP to be above normal range (>3 mg/L) are given either placebo or one of three doses of resomelagon (40, 70, 100 mg) once daily for 12 weeks in combination with MTX treatment. The study is designed to randomize 240 patients using treatment induced reduction in DAS28-CRP as the primary efficacy readout in line with the current guidelines from FDA and EMA. The study will be conducted at clinical sites in the US and in Europe with enrolment of all patients planned to be completed in Q4 2025. Capital Markets Day SynAct Pharma will hold a Capital Markets Day on Monday, September 23, 10:00-13:00 CEST at GT30, Grev Turegatan 30 in Stockholm. The presentations will give an update on SynAct Pharma’s strategy and offer an opportunity for participants to learn more about resomelagon’s role in resolving inflammation through selective activation of the melanocortin system and the company’s next clinical development of resomelagon with the Phase IIb clinical study ADVANCE in the US and Europe. Location: Grev Turegatan 30, 114 38 Stockholm Date: Monday, September 23, 2024 Time: 10:00-13:00. The venue opens at 09:30. The Capital Markets Day will be held in English. Presentation material will be available on SynAct’s website afterwards. Registration for the Capital Markets Day is made by emailing: investor.relations@synactpharma.com For further information, please contact: Jeppe Øvlesen CEO, SynAct Pharma AB Phone: + 45 2844 7567 E-mail: investor.relations@synactpharma.com About SynAct Pharma AB SynAct 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 more information: www.synactpharma.com. Attachments SynAct initiates the Phase 2b ADVANCE study with resomelagon (AP1189) in the US

Phase 2Clinical Result

13 Sep 2024

·synactpharma.com

SynAct Pharma to present clinical data on resomelagon (AP1189) at ACR Convergence

SynAct Pharma AB (“SynAct”), a clinical-stage biotechnology company focused on resolving inflammation through selective activation of the melanocortin system, today announced that an abstract for resomelagon (AP1189) has been selected for presentation at the American College of Rheumatology (ACR) Convergence 2024 conference, being held in Washington DC, USA, from November 14 to 19. At the conference SynAct Pharma will present clinical data from the Phase 2b EXPAND study with focus on the treatment potential of resomelagon (AP1189) in newly diagnosed rheumatoid arthritis patients with high disease activity and signs of active inflammation. “We look very much forward to presenting the EXPAND-study clinical data at the ACR Convergence 2024, the world's premier rheumatology event,” said SynAct’s CSO Thomas Jonassen. “The development of resomelagon (AP1189) in the patient population is continued in the Phase 2b ADVANCE study.” Resomelagon is a novel, once-daily tablet with anti-inflammatory and pro-resolving effects with the potential to treat active rheumatoid arthritis. Further information related to the accepted abstract will, due to embargo policies, be shared at a later timepoint when the abstract is published in a special online supplement of the scientific journal Arthritis & Rheumatology. 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 more information: www.synactpharma.com. AttachmentsSynAct Pharma to present clinical data on resomelagon (AP1189) at ACR Convergence

Phase 2

100 Deals associated with Resomelagon

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Indication	Highest Phase	Country/Location	Organization	Date
Inflammation	Phase 2	United States	SynAct Pharma ApS	01 Oct 2024
Inflammation	Phase 2	Bulgaria	SynAct Pharma ApS	01 Oct 2024
Inflammation	Phase 2	Denmark	SynAct Pharma ApS	01 Oct 2024
Inflammation	Phase 2	Moldova	SynAct Pharma ApS	01 Oct 2024
Inflammation	Phase 2	Poland	SynAct Pharma ApS	01 Oct 2024
Nephrotic Syndrome	Phase 2	Sweden	SynAct Pharma ApS	30 Jan 2022
Respiratory Distress Syndrome, Adult	Phase 2	Sweden	SynAct Pharma ApS	30 Jan 2022
Idiopathic Membranous Glomerulonephritis	Phase 2	Denmark	SynAct Pharma ApS	31 Aug 2020
Infantile multisystem neurologic-endocrine-pancreatic disease	Phase 2	Denmark	SynAct Pharma ApS	31 Aug 2020
Proteinuria	Phase 2	Denmark	SynAct Pharma ApS	31 Aug 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04004429 (BEGIN, CTgov)	Phase 2	Rheumatoid Arthritis	105	50 mg AP1189 (50 mg AP1189)	bfcstjozsx = oxemaamtxn nalnbuzehv (pgubtnmjgy, hojvowrrug - otvitrriig) View more	-	10 Jul 2024
				AP1189 (100 mg AP1189)	bfcstjozsx = tcalzyllqs nalnbuzehv (pgubtnmjgy, qkumjdform - azwlxhnfpn) View more
NCT05516979 (EXPAND，SynAct-CS007, NEWS 1 \| NEWS 2)	Phase 2	Rheumatoid Arthritis	55	Resomelagon	tlcdbagmjw(uwmmeeiuyk) = ywgqbttwnm wpyqigfkab (gqakzvlzrm ) View more	Positive	22 Feb 2024
				安慰剂	tlcdbagmjw(uwmmeeiuyk) = athyjvckgg wpyqigfkab (gqakzvlzrm ) View more
NCT05516979 (EXPAND，SynAct-CS007, ACR2023 \| NEWS)	Phase 2	Rheumatoid Arthritis	127	Resomelagon	bkmdegctqt(mesxpsaflu) = fvwxmyvbfg blnxkcjaop (rrcfwtwhdp )	Negative	04 Sep 2023
				安慰剂	bkmdegctqt(mesxpsaflu) = beuwinwusc blnxkcjaop (rrcfwtwhdp )

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