resomelagon (AP1189) / SynAct Pharma - LARVOL DELTA

Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Federal University of Minas Gerais | Not yet recruiting ➔ Recruiting

Enrollment open • Dengue Fever • Infectious Disease

SynAct Pharma AB…announced results from a post-hoc analysis of the Phase 2b ADVANCE study evaluating resomelagon in treatment-naïve patients with highly active rheumatoid arthritis ('RA') (ACCESS Newswire) - "Approximately one in five patients in the ADVANCE study were identified as experiencing a flare-up at enrollment, reflecting a temporary peak in inflammation. The post-hoc analysis showed that this subgroup accounted for the vast majority of the response variability in the placebo arm. Among the approximately four in five ADVANCE patients with more stable baseline high-sensitivity CRP ('hsCRP') levels, ACR20 response rates were 79% with resomelagon 40 mg and 55% with placebo (p < 0.05)....The post-hoc analysis supports a clinically meaningful treatment effect of resomelagon and its continued development at a dose of 40 mg once daily in a Phase 3 trial....SynAct plans to submit the proposed trial design and supporting toxicology program to the FDA in early Q4 2026 for discussion at an FDA Type C meeting with feedback expected end of the year or early 2027....SynAct plans to submit the findings for publication in scientific journals and for presentation at rheumatology congresses."

FDA event • New P3 trial • P2b data • Rheumatoid Arthritis

SynAct Pharma receives favorable US patent decision for immediate-release resomelagon tablet formulation (SynAct Pharma Press Release) - "...(USPTO) has issued a favorable Decision on Appeal in U.S. patent application No. 18/065,702, Appeal No. 2026-000924, relating to an immediate-release solid oral dosage formulation of resomelagon (AP1189 acetate)...The decision is an important step in SynAct’s strategy to strengthen the intellectual property protection around resomelagon. The appeal concerned whether it was obvious to formulate resomelagon as an immediate-release tablet designed to dissolve rapidly in acidic gastric conditions and support fast absorption. SynAct argued that this was not routine, given the compound’s known sensitivity under acidic conditions, and the PTAB supported SynAct’s position on obviousness."

Patent • Rheumatoid Arthritis

BIO International USA confirms growing interest in resomelagon and SynAct Pharma following the positive effects of the ADVANCE study (TradingView) - "Particular attention has focused on the ACR20 result, one of the most established efficacy measures in rheumatoid arthritis...SynAct also notes that the ACR20 levels observed in the ADVANCE study are in line with those historically reported for several established RA therapies....In addition, the demonstrated reduction in systemic inflammation, reflected by improvements in biomarkers such as C-reactive protein (CRP) and neutrophil-to-lymphocyte ratio (NLR), provides additional support for the potential application of resomelagon beyond RA...SynAct believes that the positive effects from the ADVANCE study, together with the additional clinical data expected later this year, have materially increased the strategic attractiveness of the resomelagon program."

P2 data • Rheumatoid Arthritis

SynAct obtains key US patent for resomelagon securing exclusivity until 2044 (SynAct Pharma Press Release) - "The USPTO has announced that the US patent 12,661,336 will be issued on 23 June 2026. Importantly, the US patent has been awarded a Patent Term Adjustment (PTA) of 742 days, which extends the duration of the US patent until 02 July 2044."

Patent • Rheumatoid Arthritis

RESPIRE: A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: SynAct Pharma Aps

New P2 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

SynAct Pharma to present at the BioStock Global Forum 2026 on May 21 (TradingView) - "During the event, SynAct Pharma’s CBO, Mads Bjerregaard, will provide an update on the company’s latest development of resomelagon and addressing expectations leading up to topline results of Phase 2b ADVANCE study in rheumatoid arthritis expected in June."

Clinical • P2b data • Rheumatoid Arthritis

SynAct-CS010: A randomized, double blind, placebo-controlled, phase II, multicentre trial to explore the efficacy and safety of oral AP1189 tablets administered at the dose 100 mg/day for 12 weeks in patients diagnosed with polymyalgia rheumatica and in remission on glucocorticoid (clinicaltrialsregister.eu) - P1/2 | N=60 | Not yet recruiting | Sponsor: Synact Pharma ApS

New P1/2 trial • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology • CRP

SynAct Pharma Targets RA Partnerships With BIO-Europe Spring 2026 Showcase (TipRanks) - "SynAct Pharma will present and hold partnering meetings at the BIO-Europe Spring 2026 conference in Lisbon, using the high-profile investor and business development forum to showcase its lead candidate resomelagon for rheumatoid arthritis....Management emphasizes that resomelagon’s differentiated mechanism could expand treatment options without increasing immune suppression risk, a key consideration for clinicians and patients in rheumatoid arthritis."

Clinical • Rheumatoid Arthritis

CS008: 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-nave participants with early rheumatoid arthritis and active inflammation. (clinicaltrialsregister.eu) - P1/2 | N=172 | Active, not recruiting | Sponsor: Synact Pharma ApS | Recruiting ➔ Active, not recruiting

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

In early February, the company completed recruitment for the phase IIb ADVANCE study in rheumatoid arthritis. (BioStock) - "With 246 patients enrolled and topline data expected in the second quarter 2026, preparations for phase III development are now underway."

P2 data • Rheumatoid Arthritis

SynAct Pharma to host Capital Markets Day in Stockholm on March 11 (SynAct Pharma Press Release) - "The capital markets day will provide investors, analysts, and the media with an update on SynAct’s clinical development programs and priorities focused on resomelagon applications in rheumatoid arthritis and respiratory viral infections."

Pipeline update • Respiratory Diseases • Rheumatoid Arthritis

SynAct Pharma successfully reached recruitment goal in Ph2b ADVANCE study (SynAct Pharma Press Release) - "After the last patient passes 12 weeks, follow-up visit, and completes the study, the process of closing the database across more than 30 sites will commence ensuring all data is included per protocol. Following this, statistical analysis and evaluation of the results will be done before top-line results are shared."

Enrollment closed • Rheumatoid Arthritis

Setting the stage for 2026 (BioStock) - "As SynAct moves into 2026, the primary focus remains on the phase IIb ADVANCE study in Rheumatoid Arthritis, where more than 220 of the 240 patients needed have been recruited, and as such full recruitment expected in early Q2 2026."

Enrollment status • Rheumatoid Arthritis

Resomelagon Phase-2B ADVANCE Study Update: 190 Patients Randomized Tracking for Year-End Recruitment Completion (SynAct Pharma Press Release) - "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."

Trial status • Rheumatoid Arthritis

Baicalin ameliorates high-fat diet induced MAFLD by inhibiting ERK/PPARγ/CD36 pathway. (PubMed, Phytomedicine) - "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."

Journal • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • CD36 • IL1B • IL6 • PPARG • SCARB1 • TNFA

Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2) (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Federal University of Minas Gerais | Initiation date: Apr 2025 ➔ Feb 2026

Trial initiation date • Dengue Fever • Infectious Disease

SynAct Pharma Refines Development Strategy for Lead Compound Resomelagon (AP1189) (TradingView) - "SynAct Pharma AB...updates on the development strategy for the lead compound resomelagon (AP1189). The compound offers an opportunity to promote inflammatory resolution and a novel treatment approach in inflammatory diseases....In brief SynAct will execute the strategy as follows: Continue recruitment in the ADVANCE Ph2b study with the aim to have all patients dosed in 2025; Initiate a Phase 2a Proof concept study in Polymyalgia Rheumatica."

Pipeline update • Trial status • Immunology • Inflammation • Rheumatoid Arthritis

SynAct receives Issue Notification and Patent Term Adjustment for US patent covering resomelagon (AP1189) combination therapy (SynAct Pharma Press Release) - "SynAct Pharma AB...announced today that the Unites States Patent and Trademark Office (USPTO) has provided the issue notification of US patent 12,303,489 with issue date 20 May 2025 and more than 2 years of Patent Term Adjustment added to the patent’s expiry date....SynAct’s recently announced that US patent application 17/609,849 with claims covering a method of treating rheumatoid arthritis (RA) with resomelagon (AP1189) in combination with methotrexate (MTX) had been allowed for grant of a US patent. The USPTO has now provided the Issue Notification with an issue date for US patent 12,303,489 of 20 May 2025. Importantly, the Issue Notification also determines that that the US patent is awarded a Patent Term Adjustment (PTA) of 769 days, which period is added to the ordinary expiration date of 7 May 2040 to extend the duration of the US patent until 15 June 2042."

Patent • Rheumatoid Arthritis

SynAct Pharma secures patent for resomelagon in combination with MTX (BioStock) - "The United States Patent and Trademark Office has issued a Notice of Allowance for SynAct Pharma’s patent application covering the use of resomelagon in combination with methotrexate (MTX) for the treatment of rheumatoid arthritis. This indicates that the patent office intends to grant the patent, further strengthening the company’s patent portfolio....The company’s phase IIb clinical trial in RA is underway in both the US and EU, with patient enrolment expected to be completed in Q4 2025....The patent will ensure protection at least until 2040."

Enrollment status • Patent • Rheumatoid Arthritis

SynAct Pharma Announces Initiation of Phase II Study with resomelagon (AP1189) for the Treatment of Patients with Dengue (SynAct Pharma Press Release) - "SynAct Pharma AB...announced that the RESOVIR-2 study, an exploratory Phase 2 trial to evaluate the safety and efficacy of the company’s lead candidate drug resomelagon (AP1189) in patients with Dengue has been initiated at clinical sites in Brazil....RESOVIR-2 is a randomized placebo-controlled, phase II study testing once daily oral dosing of Resomelagon (AP1189) vs placebo (1:1 randomization, n=120) as add on to standard treatment in patients with symptomatic Dengue. The potential treatment effect of resomelagon will be evaluated by time to disease resolution though a composite clinical end point. Secondary clinical end points include the ability to reduce the incidence of warning signs of and/or the development of severe dengue."

Trial status • Infectious Disease

Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2) (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Federal University of Minas Gerais

New P2 trial • Dengue Fever • Infectious Disease

The European Patent Office issues an Intention to Grant a European Patent Covering the Clinical Formulation of Resomelagon (AP1189) (SynAct Pharma Press Release) - "SynAct Pharma AB...announced that the European Patent Office (EPO) on 14 March 2025 has issued an intention to grant of a European Patent with claims covering the formulation of resomelagon (AP1189) currently undergoing development in clinical phase 2b....In addition to the US patent recently issued covering the specific salt form under clinical development, the present European patent will issue in a complementary patent family covering the formulation of these salt forms and as such will fortify the protection of resomelagon and the drug product in development. The formulation patent will provide exclusivity in Europe for SynAct’s lead asset until 2042 in all uses."

Patent • Renal Disease • Rheumatoid Arthritis

Pivotal US Patent Protecting Resomelagon (AP1189) Granted to SynAct Pharma (SynAct Pharma Press Release) - "SynAct Pharma AB...announced that today, March 4, 2025, the United States Patent and Trademark Office (USPTO) has issued US patent 12,239,631 with claims covering the crystal form of resomelagon (AP1189) currently undergoing development in clinical phase 2b....The US patent is a major cornerstone in the strategy to further protect SynAct’s intellectual property rights with respect to resomelagon and will add to the layers of protection ensuring exclusivity in the US of its lead asset as composition of matter until 2042.....The patent that has now issued by the USPTO is the first in its extended family of patent applications in all major markets around the globe. SynAct continues to pursue additional patent families to further enhance its existing patent estate protecting aspects of resomelagon."

Patent • Rheumatoid Arthritis

A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria (clinicaltrials.gov) - P2 | N=23 | Recruiting | Sponsor: SynAct Pharma Aps | Trial completion date: Dec 2024 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Glomerulonephritis • Nephrology • Renal Disease