D-0120 / InventisBio - LARVOL DELTA

DDintensity: Addressing imbalanced drug-drug interaction risk levels using pre-trained deep learning model embeddings. (PubMed, Artif Intell Med) - "Additionally, case studies on chemotherapeutic drugs, DB00398 (Sorafenib) and DB01204 (Mitoxantrone) used in oncology, were conducted to demonstrate the specificity and effectiveness of the this methods. Our approach demonstrates high scalability across DDI modalities, as well as the discovery of novel interactions. In summary, we introduce DDIntensity as a solution for imbalanced datasets in bioinformatics with pre-trained deep-learning embeddings."

Journal • Oncology

Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Gout • Inflammatory Arthritis • Rheumatology

Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients (clinicaltrials.gov) - P2 | N=121 | Completed | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Completed

Trial completion

Repurposing FDA-approved drugs for combating tigecycline resistance in Acinetobacter baumannii: in silico screening against BaeR protein. (PubMed, Mol Divers) - "Acinetobacter baumannii is becoming a gravely threatening nosocomial infection with a higher mortality rate. The per-residue interaction analysis confirmed that interactions with binding site residues were stable throughout the simulation. As a result of the study, four compounds, namely ZINC000003801919, DB01203, DB11217 and ZINC0000000056652, were identified as efficient candidates to deal with antimicrobial resistance in A. baumannii."

FDA event • Journal • Infectious Disease

Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: InventisBio Co., Ltd | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jul 2024 ➔ Jul 2025

Combination therapy • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients (clinicaltrials.gov) - P2 | N=121 | Recruiting | Sponsor: InventisBio Co., Ltd | Phase classification: P2b ➔ P2 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Phase classification • Trial primary completion date

Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: InventisBio Co., Ltd | Trial completion date: Apr 2024 ➔ Dec 2024 | Trial primary completion date: Jan 2024 ➔ Jul 2024

Combination therapy • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients (clinicaltrials.gov) - P2b | N=121 | Recruiting | Sponsor: InventisBio Co., Ltd | N=90 ➔ 121

Enrollment change

Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: InventisBio Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Gout • Inflammatory Arthritis • Rheumatology

Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients (clinicaltrials.gov) - P2b | N=90 | Recruiting | Sponsor: InventisBio Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open

Evaluation of PK and Safety of D-0120 and Allopurinol (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: InventisBio Co., Ltd | Active, not recruiting ➔ Completed

Trial completion

Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

Combination therapy • New P2 trial • Gout • Inflammatory Arthritis • Rheumatology

Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients (clinicaltrials.gov) - P2b | N=90 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P2b trial

D-0120 Safety and PK/PD Study in China (clinicaltrials.gov) - P1/2 | N=52 | Completed | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Completed | Trial primary completion date: Jun 2021 ➔ Dec 2021

Trial completion • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Evaluation of PK and Safety of D-0120 and Allopurinol (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Trial completion date: Apr 2022 ➔ Jul 2022

Trial completion date

Seawater fungi-derived compound screening to identify novel small molecules against dengue virus NS5 methyltransferase and NS2B/NS3 protease. (PubMed, Inform Med Unlocked) - "Both licensed medications, estramustine (DB01196) and quinestrol (DB04575), were found to be similar to Chevalone E, with prediction scores of 0.818 and 0.856, respectively. In addition, cholic acid (DB02659), acitretin (DB00459), and mupirocin (DB00410) are similar to Sterolic acid, zidovudine (DB00495), imipenem (DB01598), and nadolol (DB01203) are similar to Brocazine A, and budesonide (DB01222) and colchicine (DB01394) are related to Brevione K. These findings suggest that these could be feasible dengue virus treatment options, meaning that more research is needed."

Journal • Dengue Fever • Infectious Disease • Novel Coronavirus Disease

Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: InventisBio Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

D-0120 Safety and PK/PD Study in China (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: InventisBio Inc.; Trial completion date: Jul 2021 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

[VIRTUAL] PHASE I STUDY OF D-0120, A NOVEL URAT1 INHIBITOR IN CLINICAL DEVELOPMENT FOR HYPERURICEMIA AND GOUT (EULAR 2020) - "The results of the in vitro hURAT1 expressed CHO cell model showed that the inhibitory activity of D-0120 is 150-fold more potent than lesinurad and slightly more potent than verinurad...A Safety Review Committee reviewed safety, PK and PD data for each cohort of D-0120 dose level (2.5 mg, 5 mg, 10 mg, 20 mg) as well as when D-0120 5 mg was combined with 40 mg febuxostat... The oral daily administration of a novel URAT1 inhibitor, D-0120, in healthy volunteers for 7 days was well tolerated at dose levels from 2.5 mg/day to 20 mg/day. The PK profile demonstrated a dose proportional increase. D-0120 administration for 7 days resulted in significant reduction of serum UA levels."

Clinical • P1 data • Gout • Immunology • Rheumatology

"Rheumatologe: D-0120, a Novel Oral Selective Uric Acid Transport... https://t.co/fCVhZDpCMa #gout #hyperuricemia #EULAR2020" (@Rheumatologe)

Gout • Rheumatology

D-0120 Safety and PK/PD Study in China (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: InventisBio Inc.; Trial completion date: Jul 2020 ➔ Jul 2021; Trial primary completion date: May 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: InventisBio Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: InventisBio Inc.

Clinical • New P1 trial

Efficacy and safety of a new 5% minoxidil formulation in male androgenetic alopecia: A randomized, placebo-controlled, double-blind, noninferiority study. (PubMed, J Cosmet Dermatol) - "DC0120 was as safe and effective as a similar marketed minoxidil product for stimulating hair growth in men with AGA."

Clinical • Head-to-Head • Journal