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KDDF-201406-04 Pre-Clinical Study on Novel Anti-Microbial, MycosTericin, for Treatment of Skin Infections(Infectious Diseases, Protein) [10.01.2014]

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Development and Market Objectives

MycosTericin containing an antimicrobial peptide (named HG1) as a main ingredient, is a topical candidate for the treatment of recalcitrant skin infections. Our objective is to conduct pre-clinical tests of MycosTericin for evaluating its toxicity and stability, and then to obtain approval as an indicant for clinical trials.

 (* The bioactive peptide HG1 has already been approved as an IND for the treatment of stomatitis by the Korea Food and Drug Administration)

Unmet Medical Need & Target Patients

 - Target Patient Group
* Skin infections caused by a wide range of pathogenic bacteria and/or fungi (impetigo, ecthyma vulgare, candidiasis, tinea versicolor, acne vulgaris etc)
 * Chronic inflammatory skin diseases with secondary infections, which are commonly due to a defective epidermal barrier and dryness of the skin resulted from inheritable immunologic abnormality (atopic dermatitis).

 -  Unmet Medical Needs
* As has been observed in a number of systemic infectious diseases, rapidly emerging antimicrobial resistant microbes also pose a serious threat to the treatment of skin and soft tissue infections. In addition, skin diseases are frequently associated with poly-microbial infections caused by a variety of pathogenic bacteria and fungi. Accordingly, it is imperative to develop novel antimicrobial agents that possess a mode of action distinctly different from conventional drugs and a broad antimicrobial spectrum. 
* Biofilms are complex poly-microbial communities attached to a surface and embedded in an extracellular matrix. Up to 80% of all chronic skin infections are known to be caused by biofilms. For several reasons, biofilms are highly resistant to killing by microbicidal agents and thereby biofilm infections are difficult to eradicate with currently available antimicrobial treatment. Therefore, there is an urgent need for novel therapeutic to cope with biofilm involved in skin infections.

Status

- It was previously determined that HG1 had no toxicity upon administering unto the skin. As a result, HG1 was approved as an IND for mouthwash to manage oral mucositis.
- MycosTericin containing HG1 was named in accordance with the meaning that it could exert both fungicidal (Mycos) and bactericidal (Tericin) activity. MycosTericin has been confirmed to be highly effective in a model of animal infected with MRSA or Candida albicans.
- Experiments for toxico-kinetics of MycosTericin have been preparing to verify its safety when being administered onto the skin. The pilot toxicity experiment of HG1 in rodents has been completed.

Intellectual Property

- We currently hold a patent for materials based on a halocidin structure as an original and newly developed material and this also covers some halocidin isomers including HG1 generated by substitutions or the addition of amino acids to the halocidin structure.
 
- Antimicrobial peptides have entirely distinct biochemical features to existing therapies and the strategies employed in existing external preparations cannot be used. A patent for MycosTericin covering the efficacy of antimicrobial peptides may be feasible.
  

No. Type Title Registration
(YYMMDD)
Patentee status
1 INTERNATIONAL Antimicrobial peptide isolated
from halocynthia aurantium
07504380
Reg Date
 (2009.03.17)
Hoseo Peptide Inc. Registered
2 INTERNATIONAL アカボヤから分離された抗菌ペプチド JP4226555
Reg Date (2008.12.05)
Hoseo Peptide Inc. Registered
3 DOMESTIC Antimicrobial Peptide Having
Reduced Hemolytic Activity
1008491620000
Reg Date (2008.07.23)
Hoseo Peptide Inc. Registered
4 DOMESTIC  
Antimicrobial peptide isolated
from Halocynthia aurantium
1004914230000
Reg Date (2005.05.17)
Hoseo Peptide Inc. Registered
5 DOMESTIC New bacteroides and use of antibacterial  peptide derived from silk-sea squirt 1020140064369
출원일자 (2014.05.28)
Hoseo Peptide Inc. Applied

- The duration of the material patent is until 2027. Exclusivity in major markets is secured.

Competitive Advantages

- As a promising candidate for new drug based on antimicrobial peptide (AMP), HG1, major component of MycosTericin, has critical advantages over hitherto-known AMPs that had entered clinical trials for development as a topical antibiotic. HG1 exerts its profound antimicrobial activity even in the presence of a range of proteases and anionic components of extracellular matrix that might occur in a skin infection lesion, which is an essential property for AMPs to be developed as a clinically available drug. 
- MycosTericin could become an effective antimicrobial for treatment of multiple infections with a wide range of pathogenic microbes including recalcitrant strains resistant to conventional antimicrobial drugs.
- MycosTericin exhibited a strong anti-biofilm effect against microbial biofilms generated by bacteria and/or Candida albicans.
- As has been observed in many AMPs, MycosTericin also has a fast and distinct mode of action in killing microbes. 

Indication

Infectious disease (Skin infections)

Research Period

Aug., 2014 ~ Aug., 2015

Company

Hoseo Peptide Inc.

Developmental Stage

Nonclinical

Additional Information

Contact Information

Contact
Address Company Name: Hoseo Peptide Inc.
WebSite Homepage: http:// Contact Person: Lee In Hee
E-mail: leeih@hoseo.edu Contact: +82-10-3232-0328

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