MedPath

Pharmaessentia Corp. Advances with Phase III Clinical Trial for P1101 Targeting Pre-fibrotic/Early PMF

PharmaEssentia Corp. has submitted a Phase III clinical trial protocol for Ropeginterferon alfa-2b (P1101) to the China National Medical Products Administration, targeting adult patients with pre-fibrotic/early primary myelofibrosis or overt primary myelofibrosis at low or intermediate-1 risk.

On January 3, 2025, PharmaEssentia Corp. announced the submission of a Phase III clinical trial protocol for Ropeginterferon alfa-2b (P1101) to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This trial is aimed at adult patients suffering from pre-fibrotic/early primary myelofibrosis or overt primary myelofibrosis at low or intermediate-1 risk, as classified by the Dynamic International Prognostic Scoring System Plus (DIPSS Plus).
This submission represents a significant milestone in the development of P1101, with the company planning to seek marketing authorization post-trial. The trial is a component of the multinational, multicenter global study known as HOPE-PMF. Notably, Ropeginterferon alfa-2b has already received approval for the treatment of Polycythemia Vera (PV) in nearly 40 countries, including major markets like the United States, Japan, China, and the European Union.
The announcement underscores the potential market impact and the strategic importance of this phase in the drug's development. However, specific financial details have not been disclosed to safeguard the interests of the company and its investors. PharmaEssentia Corp. has also advised investors to exercise caution due to the inherent risks and uncertainties associated with new drug development.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Advancements and Challenges in Clinical Trials: A 2024 Overview

2024 has seen significant progress in clinical trials across various diseases, including neurodegenerative diseases, cancer, and eye diseases, with several treatments moving into pivotal Phase III trials. However, the year also witnessed challenges, including missed endpoints in trials targeting motor neurone disease and setbacks in depression treatment trials.

Simcere's Sublingual Edaravone Poised for Global Phase III Trial Following China Approval for Acute Ischemic Stroke

Simcere's sublingual edaravone/dexborneol, Sanbexin, has received approval in China for treating acute ischemic stroke, marking a significant advancement in stroke therapy.
Clinical data indicates that Sanbexin sublingual improved functional outcomes in acute ischemic stroke patients by approximately 10% at day 90.

AI-Discovered Drug INS018_055 Enters Phase 2 Trials for Idiopathic Pulmonary Fibrosis

INS018_055, an AI-discovered drug developed by Insilico Medicine, has advanced to Phase 2 clinical trials for Idiopathic Pulmonary Fibrosis (IPF).
The drug targets TNIK, an antifibrotic protein identified using Insilico's PandaOmics and Chemistry42 AI platforms, demonstrating safety and tolerability in Phase 1 trials.

MannKind Initiates Phase 3 Trial of Clofazimine Inhalation Suspension for NTM Lung Disease

MannKind Corporation has started its Phase 3 ICoN-1 trial to assess Clofazimine Inhalation Suspension for treating nontuberculous mycobacterial (NTM) lung disease.
The ICoN-1 study, a global, randomized, double-blind, placebo-controlled trial, aims to enroll approximately 230 participants across more than 100 sites.

Hansoh Pharma's Aumolertinib Plus Chemotherapy Shows Positive Phase III Results in EGFR-Mutated NSCLC

Hansoh Pharmaceutical's Aumolertinib (Ameile) combined with chemotherapy met its primary endpoint in a Phase III trial (AENEAS2) for first-line treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
The AENEAS2 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with Aumolertinib plus chemotherapy.

Infigratinib Receives FDA Breakthrough Therapy Designation for Achondroplasia

The FDA granted Breakthrough Therapy Designation to BridgeBio's infigratinib for treating children with achondroplasia, a genetic bone growth disorder.
Phase 2 PROPEL 2 trial data showed infigratinib led to a statistically significant increase in annualized height velocity (AHV) in children.

Nerandomilast Shows Promise in Phase 3 Trial for Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim's nerandomilast met its primary endpoint in the Phase 3 FIBRONEER-IPF trial, demonstrating improved lung function in IPF patients.
The trial is the first in a decade to meet its primary endpoint, offering hope for a new treatment option for this progressive disease.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial for Idiopathic Pulmonary Fibrosis

Nerandomilast met the primary endpoint in the FIBRONEER-IPF trial, demonstrating a statistically significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo.
The FIBRONEER-IPF trial, involving over 1177 patients across more than 30 countries, stands as the largest IPF trial conducted to date.

Ropeginterferon Alfa-2b Evaluated in Phase 3 Trial for Early/Lower-Risk Myelofibrosis

A phase 3 clinical trial is underway to evaluate Ropeginterferon alfa-2b (Ropeg) in patients with early/lower-risk primary myelofibrosis (PMF).
The study is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of Ropeg in this patient population.

PharmaEssentia Launches Phase 3b Trial of Ropeginterferon Alfa-2b for Polycythemia Vera with Accelerated Dosing

PharmaEssentia initiates a Phase 3b clinical trial (ECLIPSE PV) to evaluate an accelerated dosing schedule of ropeginterferon alfa-2b-njft (BESREMi) for polycythemia vera (PV).
The trial will compare the accelerated dosing regimen to the current labeled dosing, aiming for rapid hematologic and molecular response in PV patients.

Reference News

[1]
Pharmaessentia Corp. Submits Phase III Clinical Trial of P1101 for Pre-fibrotic/Early PMF or ...
marketscreener.com · Jan 4, 2025

PharmaEssentia Corp. submitted a Phase III trial protocol for Ropeginterferon alfa-2b to China's CDE, targeting myelofib...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy