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KDDF-201404-09 Preclinical in vivo study to evaluate the additional mechanism of action(MoA) and to demonstrate the enhanced therapeutic efficacy following the repeated dosing of YH14618(Others, Protein) [08.05.2014]

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Development and Market Objectives

• In a previous first-in-human study following single intradiscal injection of YH14618 in patients with degenerative disc disease suffering from chronic low back pain, YH14618 showed potential therapeutic efficacy. The objective of the current preclinical study is to generate robust molecular mechanistic data related to disc regeneration and pain control that may translate into enhanced clinical efficacy following repeated dosing of YH14618 in patients with degenerative disc disease.

Unmet Medical Need & Target Patients

Unmet Medical Needs
• Currently, there are no approved treatments that can modify degenerative changes in the disc.
• Pain killers have temporary efficacy, with concerns for side effects related to long-term use, while surgical intervention is not satisfying the needs of patients, despite high operation costs.
• Therefore, there is a high clinical demand for the development of safe and efficacious drugs that can modify the disease course and provide sufficient sustainable pain control.
Target Patient Population
• Patients with mild to moderate degenerative disc disease who have not experienced adequate control of chronic low back pain on NSAIDs or other conservative treatments.

Status

• A first-in-human clinical trial in patients with degenerative disc disease has been completed.

• An additional preclinical study is being carried out by a global CRO.

• A phase 2 clinical study is underway (YH14618-202; NCT02320019; KDDF-201408-07) with topline results expected in May 2016.

Intellectual Property

• International patents in over 20 countries have been granted, including patent registration in Korea.

Competitive Advantages

• Competitors such as cell therapies and recombinant proteins are being developed but their pharmacological efficacy on disc regeneration and pain control in patients with degenerative disc has not been confirmed.

• YH14618, a first-in-class disease modifying therapeutic for the treatment of degenerative disc disease, offers clinical benefit for both long term pain relief and prevention of disease progression.

• YH14618 is a peptide composed of natural amino acids with excellent safety and commercially competitive qualities.

 

Indication

Degenerative Disease

Research Period

July, 2014 ~ Oct, 2016

Company

Yuhan

Developmental Stage

Preclinical
 

Additional Information

Contact Information

Contact
Address Company Name: Yuhan Co., Ltd.
WebSite Homepage: http://www.yuhan.co.kr Contact Person: Park Sang-Koo
E-mail: skpark@yuhan.co.kr Contact: +82-31-899-4185

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