Click here to close now.


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 -


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
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Countless business models have spawned from the IaaS industry – resell Web hosting, blogs, public cloud, and on and on. With the overwhelming amount of tools available to us, it's sometimes easy to overlook that many of them are just new skins of resources we've had for a long time. In his general session at 17th Cloud Expo, Harold Hannon, Sr. Software Architect at SoftLayer, an IBM Company, broke down what we have to work with, discussed the benefits and pitfalls and how we can best use them ...
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem"...
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at, examined how Docker has evolved into a highly effective tool for application del...
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound...
As organizations shift towards IT-as-a-service models, the need for managing & protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection & E-Discovery of your data - whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise.
PubNub has announced the release of BLOCKS, a set of customizable microservices that give developers a simple way to add code and deploy features for realtime apps.PubNub BLOCKS executes business logic directly on the data streaming through PubNub’s network without splitting it off to an intermediary server controlled by the customer. This revolutionary approach streamlines app development, reduces endpoint-to-endpoint latency, and allows apps to better leverage the enormous scalability of PubNu...
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, San...
Apps and devices shouldn't stop working when there's limited or no network connectivity. Learn how to bring data stored in a cloud database to the edge of the network (and back again) whenever an Internet connection is available. In his session at 17th Cloud Expo, Ben Perlmutter, a Sales Engineer with IBM Cloudant, demonstrated techniques for replicating cloud databases with devices in order to build offline-first mobile or Internet of Things (IoT) apps that can provide a better, faster user e...
In today's enterprise, digital transformation represents organizational change even more so than technology change, as customer preferences and behavior drive end-to-end transformation across lines of business as well as IT. To capitalize on the ubiquitous disruption driving this transformation, companies must be able to innovate at an increasingly rapid pace. Traditional approaches for driving innovation are now woefully inadequate for keeping up with the breadth of disruption and change facin...
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, explored the IoT cloud-based platform technologies driving t...