EVO301 / AprilBio, Evommune - LARVOL DELTA

April Bio, "APB-R3, MASH treatment potential proven" [Google translation] (HIT News) - "AprilBio...announced on the 21st that the research results showing that the company's new drug candidate 'APB-R3' was effective in treating metabolic abnormality-related steatohepatitis (MASH) were published in the international academic journal 'Cell Reports Medicine (IF 11.7)'....According to the research results, IL-18, an inflammatory factor, was highly expressed in MASH patients and model animals, and liver inflammation and fibrosis were further aggravated in mice deficient in IL-18BP."

Preclinical

Treatment of IL-18-binding protein biologics suppresses fibrotic progression in metabolic dysfunction-associated steatohepatitis. (PubMed, Cell Rep Med) - "APB-R3 significantly improves MASH in reducing fibrosis and inflammation and inhibits hepatic stellate cell activation via the cGMP pathway. This study proposes that abrogation of IL-18 signaling by boosting IL-18BP can strongly inhibit the development of MASH-induced fibrosis, and our engineered IL-18BP biologics can become a promising therapeutic candidate for curing MASH."

Journal • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • CD4 • IFNG • IL18

Evommune Initiates Phase 2 Trial of IL-18 Targeted Fusion Protein, EVO301, in Adult Patients with Atopic Dermatitis (PRNewswire) - "Evommune...announced the enrollment of the first patient in a Phase 2 trial of EVO301 in adult patients with moderate-to-severe AD....The multi-center, randomized, double-blind, placebo-controlled, proof-of-concept trial is designed to evaluate the safety and efficacy of EVO301 in approximately 60 adult patients with moderate-to-severe AD. The primary objective of this study is to characterize the efficacy of EVO301, assessed by the percentage change in EASI from baseline at week 12."

Enrollment open • Atopic Dermatitis

April Bio's technology transfer candidate substance 'APB-R3' global phase 2 trial begins in earnest [Google translation] (News1 Korea) - "The global phase 2 clinical trial of 'APB-R3', a candidate substance for the treatment of autoinflammatory diseases for which April Bio...transferred technology to the US new drug developer Evommune, has begun in earnest. Evommune began recruiting clinical patients about two months after starting phase 2 clinical trials last year. The first patient administration is expected to take place soon...According to industry sources on the 5th, Evommune began recruiting patients for the phase 2 clinical trial of 'EVO301' targeting moderate to severe atopic dermatitis patients on the 24th of last month...The target number of patients is 60. EVO301 is the name of the candidate substance that changed after April Bio's APB-R3 was transferred to Evommune....April Bio will receive a milestone payment upon administration of the first patient. However, the size of the milestone payment has not been disclosed."

Commercial • Trial status • Atopic Dermatitis

April Bio, Beyond Profit with Technology Export Clinical Progress, Green Light for ‘Weight Class Increase’ [Google translation] (Money Today) - "Lundbeck is expected to secure interim data from the phase 1b clinical trial of APB-A1 for thyroid eye disease (TED) within the third quarter. Evommune is also scheduled to administer its first phase 2 patient with atopic dermatitis within the first quarter. The target completion date for the clinical trial is the fourth quarter of this year."

New P2 trial • P1 data • Atopic Dermatitis • Thyroid Eye Disease

Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Evommune, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

April Bio, Achieves Profit in 2 Years Since Listing… Confident in Technology Export Performance [Google translation] (Medipana) - "Lundbeck has announced that it is seeking a global big pharma to conduct joint development for 'APB-A1' in order to expand it to various indications. Evommune plans to conduct phase 2 clinical trials for 'APB-R3' for atopic patients in February....April Bio expressed confidence through IR data that 'an increase in corporate value is theoretically possible as both 'APB-A1' and 'APB-R3' will enter clinical trials for patients in 2025.'"

Commercial • New P2 trial • Atopic Dermatitis • Immunology

Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Evommune, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

AprilBio, APB-R3 MASH, etc. Key Indication Usage Patent Application US PCT [Google translation] (Hankyung) - "AprilBio...has newly applied for a patent for the use of its autoimmune disease treatment candidate (APB-R3) for major indications....'We are also preparing for the SAFA platform business, which aims to discover additional business opportunities in APB-R3 as well as derive a proof of concept (POC) in the second half of the year.'"

New trial • Patent • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

AprilBio licenses out autoimmune disease to US firm for $475 mil. (Korea Biomedical Review) - "AprilBio...said Thursday that it has entered into a technology transfer agreement with Evommune, a U.S. firm, for its autoimmune disease treatment candidate, APB-R3. The $475 million deal includes an upfront payment of $15 million and potential royalties from future product sales."

Licensing / partnership • Immunology • Rheumatoid Arthritis

April Bio, Autoinflammation Treatment APB-R3 Phase 1 Clinical Trial Success [Google translation] (Hankyung) - P1 | N=31 | NCT05715736 | Sponsor: Syneos Health | "April Bio...announced on the 10th that it had announced on the 7th that it had received a clinical results report (CSR) for the phase 1 clinical trial of the auto-inflammatory treatment drug 'APB-R3'....As a result, no serious adverse reactions occurred in any of the subjects, and no discontinuation of drug administration or death was reported due to this, so there were no problems with safety and tolerability, which are the primary indicators of APB-R3. In the pharmacodynamic evaluation, which is a secondary indicator, the half-life was analyzed to be 13 to 14 days, and immunogenicity was observed at a minimal level in two subjects."

P1 data • Immunology

April Bio proves safety of APB-R3 in phase 1 Australian clinical trial [Google translation] (Hankyung) - P1 | N=31 | NCT05715736 | Sponsor: Syneos Health | "Thirty-one healthy men and women participated in the clinical trial. 21 people took APB-R3, and the remaining 10 took placebo. There were no deaths or serious or serious treatment-emergent adverse events (TEAEs) in either group. The most common side effects were headache (9 patients (29%)), catheter site bruising (5 patients (16.1%)), vascular puncture site bruising (4 patients (12.9%)), and injection site bruising (4 patients (12.9%)), nausea (3 people (9.7%)), and upper respiratory infection (3 people (9.7%))."

P1 data • Immunology

AprilBio APB-R3 clinical trial good news… “Preparation for technology export ↑” [Google translation] (Hankyung) - P1 | N=31 | NCT05715736 | Sponsor: Syneos Health | "April Bio announced APB-R3 phase 1 clinical topline data...Wei Wei-ju, a researcher at Korea Investment & Securities, said of this clinical trial, 'Both safety and extension of the half-life of the SAFA platform were confirmed'....'The half-life of APB-R3 is 13 to 14 days,' and 'Considering that the half-life of a typical IL-18 binding protein is 33 to 40 hours, SAFA extends the half-life by about 9 times'....'The APB-R3 clinical results report will be released in the second quarter of this year...'"

P1 data • Immunology • Inflammatory Bowel Disease

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3 (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Syneos Health | Active, not recruiting ➔ Completed

Trial completion • Immunology

Albumin-binding recombinant human IL-18BP ameliorates macrophage activation syndrome and atopic dermatitis via direct IL-18 inactivation. (PubMed, Cytokine) - "Moreover, APB-R3 substantially controlled skin inflammation in a model of atopic dermatitis. Thus, we report APB-R3 as a new potent IL-18 blocking agent that could be applied to treat IL-18-mediated inflammatory diseases."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Hepatology • Immunology • Inflammation • IL18

Disruption of IL-18 signaling via engineered IL-18BP biologics alleviates experimental cholestatic liver disease. (PubMed, Biomed Pharmacother) - "Enhanced senescence associated secretory phenotype (SASP) markers in cholestatic liver disease were diminished by APB-R3 treatment. Our findings clearly demonstrate that the administration of IL-18BP biologics, APB-R3, effectively alleviates DDC diet-induced biliary injuries in rodent PSC model, implying APB-R3 can be a promising therapeutic reagent which warrants clinical human trials as new therapeutic options."

Journal • Cholestasis • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • IL18

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3 (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Syneos Health | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology

April Bio “Inflammatory disease treatment ’APB-R3’ Phase 1 phase in Australia completed in September… Technology transfer promoted“ [Google translation] (Newspim) - "An April Bio official said on the 8th, 'Clinical trials are underway with the goal of completing the Australian phase 1 clinical trial of APB-R3 in September. Development is underway as a subcutaneous administration formulation, and we plan to pursue technology transfer after the clinical trials are completed.' revealed....In addition, in the first half of this year, April Bio attended Bio USA and the European Association for the Study of the Liver (EASL) and held discussions with global pharmaceutical companies to export the technology of 'APB-R3'."

Licensing / partnership • Trial completion date • Immunology

Blockade of IL-18 via long-acting IL-18 binding protein attenuates experimental diet-induced cholestatic disease (EASL-ILC 2023) - "The long-acting IL-18BP, APB-R3, effectively ameliorates DDC diet-induced biliary injuries in rodent PSC model. These pre-clinical results suggest that APB-R3 can be potential leading therapeutic drug to relieve PSC disease, and our results warrant further clinical trial studies."

Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • IL18 • IL1B • MMP3 • TGFB1

APB-R3, a novel long-acting IL-18 binding protein, inhibits IL-18 activity, and thereby ameliorates NASH progress with reduced liver fibrosis (EASL-ILC 2023) - "APB-R3 treatment exhibits significant reduction of hepatic injury and fibrosis in mice NASH models, and our results emphasize the marked value of APB-R3 as a novel therapeutic arsenal in treating NASH especially when combined with anti-steatotic agents."

Addiction (Opioid and Alcohol) • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Liver Failure • Non-alcoholic Steatohepatitis • IL18

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3 (clinicaltrials.gov) - P1 | N=31 | Recruiting | Sponsor: Syneos Health | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3 (clinicaltrials.gov) - P1 | N=31 | Not yet recruiting | Sponsor: Syneos Health

New P1 trial • Immunology