Latest Hotspot

Omnix Medical gets green light from U.S. FDA for Phase II testing of its advanced anti-infective agent OMN6

28 November 2023
3 min read

The biopharmaceutical company Omnix Medical, known for creating advanced anti-infectives to combat serious infections, has reported today that their upcoming Phase II trial for their innovative anti-infective, OMN6, has received approval from the FDA.

👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug.

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

The global, multi-site study aims to evaluate the safety and pharmacokinetics of OMN6 in patients suffering from either hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia induced by Acinetobacter baumannii complex.

OMN6, a breakthrough, pioneer antimicrobial peptide originated from insect host defense peptides, is the primary compound of Omnix Medical. Its working principles contrast starkly with traditional anti-infectives; it destroys bacterial cell membranes, leading to swift and potent action, unaffected by bacterial genotype or resistance phenotype.

During a randomized, double-blind Phase I study with a placebo-controlled, single ascending dose, and more than 80 healthy volunteers, OMN6 showcased an exceptional safety profile and tolerability at clinically valuable dosage levels. Furthermore, total clearance of the pharmaceutical was achieved, facilitating multiple daily infusions typical in anti-infective treatment regimes.

We are thrilled with the U.S. FDA’s approval of our proposed Phase II study,” expressed Dr. Moshik Cohen-Kutner, Omnix Medical’s CEO. “Given the promising outcomes we’ve observed in our prior Phase I trial, we anticipate the Phase II outcomes will corroborate these findings. This could signify a crucial step forward in the creation of a new anti-infectives category, which doesn’t induce antimicrobial resistance.”

According to Dr. Niv Bachnoff, Omnix Medical’s CSO, “Our intention is to kickstart the Phase II trial in the approaching months. Our ultimate aim is to introduce a powerful alternative to traditional anti-infectives, thereby saving the lives of millions of global patients who are currently resistant to available antibiotics.”

👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs, indications, organizations, clinical trials, clinical results, and drug patents related to this target.

图表, 散点图

中度可信度描述已自动生成

According to the data provided by the Synapse Database, As of November 26, 2023, there are 7 investigational drugs for the Bacterial outer membrane proteins target, including 14 indications, 12 R&D institutions involved, with related clinical trials reaching 9, and as many as 364 patents.

OMN6 is a novel, first-in-class antimicrobial peptide based on insect host defense peptides. Its mechanism of action is based on disruption of bacterial cell membranes and is therefore effective regardless of bacterial genotype or resistance phenotype, and unlike conventional bacteriostatic antibiotics, it is fast acting and bactericidal. OMN6, the Company's lead compound, is intended for the treatment of life-threatening infections caused by Gram-negative bacteria such as Acinetobacter baumannii.

图形用户界面, 文本, 应用程序, 聊天或短信

描述已自动生成

Revumenib: A Quick Look at Its R&D Progress and Clinical Results from the 2023 ASH
Revumenib: A Quick Look at Its R&D Progress and Clinical Results from the 2023 ASH
28 November 2023
The latest clinical findings of Revumenib will be unveiled at the 2023 ASH Congress, demonstrating its potential effect and setting the stage for subsequent investigations.
Read →
The OCEANIC-AF research was prematurely terminated due to insufficient effectiveness
Latest Hotspot
3 min read
The OCEANIC-AF research was prematurely terminated due to insufficient effectiveness
28 November 2023
The OCEANIC-AF phase III trial comparing asundexian and apixaban in stroke-risk atrial fibrillation patients will end early. This is based on the Independent Data Monitoring Committee's recommendation, as asundexian showed lower efficacy than the control. Bayer will analyze the data further and share the results later.
Read →
Unveiling the Secrets of LAG3 Inhibitors: Stay Updated with the Latest Advances
Unveiling the Secrets of LAG3 Inhibitors: Stay Updated with the Latest Advances
28 November 2023
The LAG-3 molecule can negatively requlate T cells and plays an important role in maintaining thestability of the immune system and promoting tumor immune escape. As one of the new targets, LAG-3has great potential in tumor immunotherapy.
Read →
Vigil Neuroscience: Phase 2 IGNITE trial shows promising early results for Iluzanebart (VGL101) in treating ALSP
Latest Hotspot
3 min read
Vigil Neuroscience: Phase 2 IGNITE trial shows promising early results for Iluzanebart (VGL101) in treating ALSP
28 November 2023
Vigil Neuroscience has revealed encouraging initial results from the Phase 2 IGNITE clinical trial. This trial aims to test the potential of Iluzanebart (VGL101) in treating ALSP.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.