News Feed Item

Sideromics Completes Pre-IND Meeting with FDA on Siderocillin for Two Indications: MRSA Bacteremia and ABSSSI

IRVINE, Calif., April 8, 2014 /PRNewswire/ -- Sideromics LLC, a pharmaceutical company specializing in the development of novel antimicrobial compounds, announced today that the company has successfully completed a Type B pre-investigational new drug (PIND) meeting with the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products (DAIP).  The purpose of the meeting was to obtain FDA concurrence on the nonclinical, clinical, and regulatory pathway for the development of Siderocillin, a novel first-in-class antimicrobial agent.

Sideromics' Siderocillin, is a first-in-class antibiotic within the Sideromycin group.  Siderocillin employs a completely new and novel antimicrobial approach.  Sideromics is pursuing multiple indications under this IND program:

  1. Treatment of patients with hospital-acquired bacteremia due to methicillin-resistant Staphylococcus aureus (MRSA)
  2. Treatment of hospitalized patients with acute bacterial skin and skin structure tissue infections (ABSSSI)

Sideromics is currently preparing a GMP batch of Siderocillin, which will undergo a microbiological testing program discussed with the FDA.  The PIND meeting with the FDA confirmed that the initial IND for Siderocillin will not require additional nonclinical safety data to support our first phase I single dose trial in humans.  This enables Sideromics to enter the clinic promptly.

As part of the PIND meeting program, the FDA asked Sideromics to consider requesting designation of Siderocillin as a "Qualified Infectious Disease Product" (QIDP),  as well as requesting fast track designation at the time of QIDP designation.

QIDP designation is part of the Generating Antibiotic Incentives Now (GAIN) statute, created by Congress to encourage the development of therapies for drug-resistant organisms known to cause serious or life-threatening infections.  The GAIN provisions are included in the FDA Safety and Innovation Act (FDASIA) that was signed into law in July 2012.  The GAIN act is a legislative effort to incentivize the development of new antibiotic agents that target serious life-threatening infections.  Siderocillin is clearly the type of novel compound needed in medicine's current losing battle with multiresistant organisms.

By expediting and fast tracking the FDA review process, the QIDP designation will allow Sideromics to bring Siderocillin to patients with serious infections much more quickly.  QIDP status will also complement Sideromics' patent portfolio with an additional total of 10 years exclusivity in the U.S.

Research and development of antibiotics has declined in recent years and the pipeline for antibiotics today is significantly smaller than in the past.  In 1990, there were 18 major pharmaceutical companies engaged in antibiotics research, today there are only four.  Given the speed at which microbes have become resistant in recent years, the innovation in antibiotics research has not been successful in addressing this growing problem.

Number of New Antibiotics Approved by FDA

"This is a serious problem for physicians and health care workers," says Sharon Moalem MD, PhD, Sideromics cofounder and director of research, "It's like trying to fight a fire with one hand tied behind your back."  As the number of new antibiotics approved by the FDA has been declining over the last few decades, the number of individuals in the U.S. dying from infections caused by multiresistant microbes, such as MRSA has been on a steep rise.

In the latest reports (March 2014) from Centers for Disease Control and Prevention (CDC), the agency found that on any given day, approximately one in 25 patients has at least one infection contracted during the course of their hospital care.  In 2011 alone, 722,000 infections were recorded according to new data from CDC. 

"Our companies mandate was to aggressively screen compounds that target bacteria that are the so called 'superbugs' or multiresistant microbes.  We discovered Siderocillin by studying how rare human conditions evolved to protect us from microbial infections," says Moalem.

Using their first-in-class intellectual property compounds, with clinical trials set to begin by the end of 2014, Sideromics is poised to make dramatic changes to the antimicrobial landscape.

About Sideromics

Sideromics is a pharmaceutical company developing novel compounds and methods to treat or prevent diseases and disorders caused by pathogenic microorganisms, such as bacteria, fungi, and parasites.  Sideromics has developed a pipeline of products with possible indications in humans and domestic animals, as well as for use in food-animal growth & processing.  Sideromics' pipeline of products range from early proof of concept through advance stages of development.  Current and pending patents and IP cover a broad range of applications in the U.S. and on a global basis. 

Photo - http://photos.prnewswire.com/prnh/20140408/LA99615


Sideromics LLC


Investor & Public Relations:

Stacey Lense – Email:   [email protected]

Rachel Stone – Email:   [email protected]

(800) 552-1680



SOURCE Sideromics LLC

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
24Notion is full-service global creative digital marketing, technology and lifestyle agency that combines strategic ideas with customized tactical execution. With a broad understand of the art of traditional marketing, new media, communications and social influence, 24Notion uniquely understands how to connect your brand strategy with the right consumer. 24Notion ranked #12 on Corporate Social Responsibility - Book of List.
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captu...
Most of us already know that adopting new cloud applications can boost a business’s productivity by enabling organizations to be more agile and ready to change course in our fast-moving and connected digital world. But the rapid adoption of cloud apps and services also brings with it profound security threats, including visibility and control challenges that aren’t present in traditional on-premises environments. At the same time, the cloud – because of its interconnected, flexible and adaptable...
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and...
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining senso...
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
In the next five to ten years, millions, if not billions of things will become smarter. This smartness goes beyond connected things in our homes like the fridge, thermostat and fancy lighting, and into heavily regulated industries including aerospace, pharmaceutical/medical devices and energy. “Smartness” will embed itself within individual products that are part of our daily lives. We will engage with smart products - learning from them, informing them, and communicating with them. Smart produc...
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, will discuss the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docke...