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KDDF-201408-07 Phase 2b study of YH14618 for degenerative disc disease(Others, Protein) [12.05.2014]

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Development and Market Objectives

• YH14618 is a novel peptide under development as an intradiscal injection for the treatment of patients with symptomatic lumbar degenerative disc disease, to achieve the treatment goals of improvement in chronic back pain and prevention of disease progression via its modulatory effect on TGFβ1.
• The initial safety, tolerability and therapeutic efficacy of YH14618 has been investigated in a Phase 1/2a clinical trial (YH14618-201). The current study (YH14618-202; ClinicalTrial.gov Identifier: NCT02320019) is a double-blind, placebo-controlled clinical trial designed to establish proof-of-concept for the safety and efficacy of YH14618, by comparing the proportion of VAS (Visual Analogue Scale) responders, defined as those who achieve a ≥ 50% reduction from baseline score for low back pain, at Week 12 following intradiscal injection. Patients diagnosed with one or two symptomatic lumbar degenerative discs with persistent low back pain despite at least 3 months of conservative therapy are eligible.

Unmet Medical Need & Target Patients

Target Patient Population
• Patients diagnosed with one or two symptomatic lumbar (L1/L2 ~ L5/S1) degenerative discs, defined as a Pfirrmann grade of 2 to 4 (on MRI). Patients must have suffered from persistent low back pain with VAS ≥40 mm and modified Oswestry disability index (mODI) of ≥30%, despite at least 3 months of conservative therapy.
Unmet Medical Needs
• Low back pain is a common condition with approximately 80% of the population reported to experience the condition at least once during their lifetime. Although an estimated 5% of this population will develop chronic low back pain, only 20~40% of these patients respond satisfactorily to currently available treatments. Many factors can contribute to the onset of chronic low back pain, however, discogenic factors are known to be the major cause, affecting 26~42% of patients. Discogenic low back pain is a serious medical and social problem, with total health care costs in the United States estimated to exceed $100 billion per year. Degenerative disc disease can arise from the natural process of aging, but eventually becomes irreversible, and can begin when adolescents are in their twenties. Pain and the impaired mobility associated with degenerative disc disease typically affect adults between the ages of 30 and 50.
• Current treatment options for discogenic low back pain range from medicinal anti-inflammatory and pain relief strategies to invasive procedures including spine fusion and spinal arthroplasty. However, these treatments are limited to relieving symptoms, with no attempt to restore the disc structure. Additionally, there are unsatisfactory outcomes with surgical intervention due to high cost, complications, and recurrence of pain. None of the currently available treatment options satisfactorily meet the treatment goals for DDD which include long-term improvement in chronic back pain and restoration of disc structure. 

Status

• First-in-human phase 1/2a clinical trial (YH14618-201) has been completed in a total of 50 patients with symptomatic lumbar disc degenerative disease.
• A 2b clinical study (YH14618-202) in a target of 320 subjects with lumbar disc degenerative disease is currently being conducted and the subject recruitment has been completed in Jan 2016. 
In vivo study using a rabbit model of degenerative disc disease is underway to evaluate the synergistic effect of repeated dosing (KDDF-201404-09).

Intellectual Property

• Patents have been granted in approximately 20 countries including the Republic of Korea.

Competitive Advantages

• Currently, for patients with degenerative disc disease and chronic low back pain, there is no approved treatment that addresses the underlying pathophysiology responsible for the disease. Pain killers such as NSAIDs and other conservative analgesics have only temporary efficacy in general, with concerns for side effects related to long-term use. Surgical intervention is a significant undertaking and frequently does not comprehensively resolve the unmet needs of patients despite high costs. Therefore, a significant clinical demand exists for the development of safe and efficacious solutions that can modify the disease course and provide sufficient and sustainable pain control. YH14618, a first-in-class disease modifying peptide for the treatment of degenerative disc disease, is being developed as a differentiated therapeutic offering clinical benefit for both long-term pain relief and prevention of disease progression.

Indication

Others, Peptide, Disc

Research Period

Nov. 01, 2014 ~ Oct. 31, 2016

Company

Yuhan Co., Ltd.

Developmental Stage

Phase 2

Additional Information

Contact Information

Contact
Address Company Name: Yuhan Co., Ltd.
WebSite Homepage: http://www.yuhan.co.kr Contact Person: Hae Mi Byun
E-mail: hmbyun@yuhan.co.kr Contact: +82-2-828-0387

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