AK3280 / Ark Biosci - LARVOL DELTA

ArkBio Announces Positive Phase II Results of AK3280 for treatment of Idiopathic Pulmonary Fibrosis (IPF) (The Manila Times) - P2 | N=105 | NCT05424887 | Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. | "Shanghai Ark Biopharmaceutical Co., Ltd. ('ArkBio') today announced positive top-line Phase II study results for its novel anti-fibrotic drug AK3280 in treatment of idiopathic pulmonary fibrosis (IPF)....The high dose groups demonstrated FVC improvement from baseline, especially the 400 mg group which had the absolute FVC increased by 209.4 mL and a 6.4% adjusted %pFVC improvement from baseline, which is statistically significant compared to placebo (p=0.002 and 0.004, respectively). Other lung and respiratory functions have also got better. The drug exhibited a good safety and tolerability profile without the gastrointestinal intolerability issues associated with current IPF therapeutics."

P2 data • Idiopathic Pulmonary Fibrosis

Broad antifibrotic activities of AK3280 in pulmonary, hepatic, cardiac, and skin fibrosis animal models. (PubMed, Int Immunopharmacol) - "Pirfenidone (PFD) and nintedanib are approved by the FDA for treating pulmonary fibrosis, but these treatments are associated with poor tolerability and limited efficacy. AK3280 demonstrated antifibrotic effects across multiple organs, including the lungs, liver, heart, and skin, in various animal models. These results suggest that AK3280 holds promise as a clinically beneficial antifibrotic therapy for a range of fibrotic diseases, especially pulmonary, hepatic, cardiac, and skin fibrosis."

Journal • Preclinical • Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

ArkBio Presented at the 8th Annual IPF Summit and Announced Completion of Patient Enrollment for Phase 2 Clinical Trial of AK3280, a Next-Generation Drug for IPF Treatment (PRNewswire) - "Shanghai Ark Biopharmaceutical Co., Ltd...announced that Dr. Jim Wu, Chief Executive Officer of ArkBio, gave an oral presentation...at the 8th Annual IPF Summit held in Boston on August 22, 2024. AK3280 is a next-generation broad-spectrum anti-fibrotic drug for the treatment of idiopathic pulmonary fibrosis (IPF) and is undergoing a randomized, double-blind, multicenter phase 2 PoC clinical study. The clinical trial led by Professor Huaping Dai of the China-Japan Friendship Hospital, Beijing, is being conducted across 31 hospitals in China to evaluate the safety, tolerability, and efficacy of AK3280 in IPF patients."

Trial status • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Unveiling Progress: Clinical Trial Design & Strategic Insights from Phase 2 Clinical Program in IPF (IPF Summit 2024) - "Synopsis • Exploring the intricacies of the clinical trial design for AK3280 in IPF, including patient selection criteria, endpoint selection, and the overall study methodology • How the trial design addresses the unique challenges posed by IPF in the Chinese patient population, showcasing adaptations made to enhance efficacy and relevance • Insights into the regulatory landscape in China for IPF therapeutics, and innovative strategies employed to streamline regulatory processes"

Clinical • P2 data • Idiopathic Pulmonary Fibrosis

Comparative Evaluation of Particle Size Reduction, Salt Formation, and Amorphous Formulation on the Biopharmaceutical Performance of a Weak Base Drug Candidate. (PubMed, Mol Pharm) - "In this work, guided by an in silico solubility sensitivity analysis for oral absorption, a comparative assessment of the biopharmaceutical performance of a jet-milled free base, a tosylate salt, and a 50:50 (w/w) amorphous solid dispersion (ASD) with hydroxypropyl methylcellulose acetate succinate (HPMCAS) of a weak base drug candidate, GDC-3280, was conducted...Finally, a pharmacokinetic study in dogs showed that the in vivo exposure increased by 1.7- to 2-fold for the tosylate salt and ASD formulation compared with the jet-milled free base, consistent with the in silico solubility sensitivity analysis for the fraction of drug absorbed. Overall, this work provides insights into the evaluation of multiple formulation approaches for enhancing the biopharmaceutical performance of poorly water-soluble drugs."

Journal

A Study to Evaluate the Safety, Tolerability and Efficacy of AK3280 Cream on Hypertrophic Scar (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Ark Biosciences Inc.

New P1/2 trial

A Study to Evaluate the Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=105 | Not yet recruiting | Sponsor: Ark Biosciences Inc.

New P2 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Study of AK3280 in Chinese Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Ark Biosciences Inc. | Recruiting ➔ Completed | N=36 ➔ 24

Enrollment change • Trial completion

A Study of AK3280 in Chinese Healthy Volunteers (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Ark Biosciences Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A phase 1, randomized study to evaluate safety, tolerability, and pharmacokinetics of GDC-3280, a potential novel anti-fibrotic small molecule, in healthy subjects. (PubMed, Pulm Pharmacol Ther) - "Single and multiple doses of GDC-3280 were generally well tolerated, with acceptable safety and pharmacokinetic profiles that support twice-daily, oral administration with food in future clinical trials."

Clinical • Journal • P1 data • PK/PD data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pain • Pulmonary Disease • Respiratory Diseases

A Study of AK3280 in Chinese Healthy Volunteers (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Ark Biosciences Inc.

New P1 trial

A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects (clinicaltrials.gov) - P1; N=48; Completed; Sponsor: Ark Biosciences Inc.; Recruiting ➔ Completed; N=36 ➔ 48; Trial completion date: Dec 2019 ➔ Sep 2020; Trial primary completion date: Dec 2019 ➔ Sep 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date

Agco Baifa’s Series C financing is finalized, Yingke Capital continues to increase the gold track of innovative drugs [Google translation] (STCN) - "...The company's AK3280, which is used to treat a variety of fibrotic diseases such as idiopathic pulmonary fibrosis, has completed overseas phase Ib clinical trials, and will soon carry out bridging trials and phase II clinical studies in China."

New P2 trial • Trial completion • Idiopathic Pulmonary Fibrosis

A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Ark Biosciences Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Ark Biosciences Inc.

Clinical • New P1 trial

Determination of A Novel Antifibrotic Small Molecule GDC-3280 in Human Plasma and Urine by Liquid Chromatography Tandem Mass Spectrometry to Support Its First-in-human Clinical Trial. (PubMed, Biomed Chromatogr) - "Benchtop stability of 25 hrs and 5 freeze-thaw cycles were also confirmed in both matrices. The method was successfully implemented in GDC-3280's FIH trial for assessing its pharmacokinetic profiles."

Clinical • Journal • P1 data