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KDDF-201212-13 Development of New Antibiotics against Gram Negative Pathogens(Infectious Diseases, Chemical) [03.05.2013]

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Development and Market Objectives

  • Enter clinical Phase I after completion of preclinical studies.
  • After completion of Phase I,  the candidate will be developed for co-administration with a beta-lactamase inhibitor, a number of which are currently under development by global pharmaceutical companies.

Unmet Medical Need & Target Patients

     With the recent emergence of multiple drug-resistant bacteria, the focus on gram-positive bacteria (especially MRSA) has increased. However, research into strains of gram-negative bacteria, which more frequently infect elderly and severely ill patents, has been relatively low.

     Currently, very few effective drugs for gram-negative bacteria exist, particularly for Pseudomonas aeruginosa and Acinetobacter baumannii in particular, develop resistance to multi-drugs. In addition, resistance is becoming a serious problem for drugs targeting individual strains. 

     The Infectious Diseases Society of America (IDSA) has been emphasizing the need to develop antibiotics, initiating a campaign to secure 10 new drugs by 2020. This underlines the current lack of efficacious drugs, particularly those concerning gram-negative bacteria. The IDSA has underlined the magnitude of the current need by stating that while “better drugs” are needed for gram-positive bacteria, for gram-negative bacteria “any drug” will do, at least for now.

Status

     Samples are currently in production for preclinical trials, with GLP-Tox (rat, dog) studies scheduled for the latter half of this year.

     Efficacy was evaluated with systemic infection model and thigh infection model in mouse. Additionally, various animal model studies are underway (including respiratory organ infection, urinary tract infection and skin infection)

     PBP binding assays are being conducted to identify the mode of action

     Beta-lactamase stability tests are in progress to identify effects on resistant bacteria

     Combination effects with BLI are awaiting confirmation

Intellectual Property

     Applications have been submitted regarding substance patents – beginning in the US. The current patent status is shown below.

[Current patent applications regarding cephalosporin antibiotics]

#

Name of IP

Type

Date of Application

Country of Application

Application Number (Registration Number)

1

Novel cephalosporin derivatives

and Pharmaceutical Compositions Thereof

Local

2011/03/30

Korea

10-2011-0028603

PCT

2012/03/29

PCT

PCT/KR2012/002302

Overseas

2012/05/08

(2012/11/12)

US

13467019

(8,329,684)

 

Competitive Advantages

     Candidate LCB10-0200 is effective against key gram-negative bacteria, particularly P. aeruginosa. When used in combination with beta-lactamase inhibitors, the compound is effective against the gram-negative species K. peumoniae, E. coli, P. aeruginosa and A. baumannii.

 

     The competitive advantages of LCB10-0200 can be divided into four major categories.

1) P. aeruginosa exhibits tolerance to cephalosporin antibiotics, particularly carbapenems. 

2) When co-administered with tazobactam, candidate has excellent remedial effects for K. pneumonia.

3) Candidate is additionally effective for Acinetobacter, for which no current treatments exist.

4) Safety confirmed through extensive animal studies, even taking into account cardiotoxicity factors.

Indication

Antibiotic

Research Period

fab.12,2013~may.11,2014

Company

legochem

Developmental Stage

Nonclinical

Additional Information

Contact Information

Contact
Address Company Name: legochem
WebSite Homepage: http://www.legochembio.com/ Contact Person: Ye-na Park
E-mail: pyn0925@legochembio.com Contact: +82-42-861-0688

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