R&D

Drugs

01
AL101-AOB

  • Obesity has emerged as a major public health problem due to its high prevalence and association with increased risk towards the development of a metabolic syndrome

  • The incidence of lifestyle diseases like hypertension, diabetes, hyperlipidemia, various heart diseases and stroke etc. is much higher for people who have a visceral type of abdominal fatness, even if they have the same Body Mass Index (BMI) like others

  • Subcutaneous fat and visceral fat are metabolically different

  • Visceral fat contributes to the pathogenesis of the underlying metabolic syndrome

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복부비만의 문제

AL101-AOB

Background of
Development

  • Most of the anti-obesity drugs focus on weight loss

  • Obesity-related metabolic syndrome is linked to visceral fat

  • Safety is the most important issue to be considered against side effects

  • Angiogenesis inhibitors can inhibit the growth of visceral fat safely
Summary of
Product

  • AL101-AOB inhibits angiogenesis targeting VEGF, bFGF and MMP

  • AL101-AOB is a botanical drug prepared by activity-guided fractionation from Melissa

  • It is standardized by two reference compounds

  • Nonclinical studies were completed in Australia and Korea

  • Visceral fat was confirmed to be reduced during the phase ll human trial through CT analysis

Reduction of visceral fat by 15% after a 12-week treatment of AL101-AOB (CT scan)

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02
AL101-AMD

Background of
Development

  • Current anti-VEGF therapy should be intravitreally injected every 4-8 weeks

  • Side effects and risk from repeated life-long intravitreal injections

  • Poor response to anti-VEGF therapy and do not improve vision in many patients

  • Development of resistance to anti-VEGF therapy in refractory or recurrent wet AMD patients
Development Objective

  • Drug with orally available and capable of long term treatment without side effects

  • Application of AL101-AMD to other angiogenesis-dependent ocular diseases


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Summary of
Product

  • Efficacy was tested in CNV (Choroidal neovascularization) models

  • Toxicity studies were completed

  • Phase 2 clinical trial completed in 11 clinical sites, Licensing-out AL101-AMD (Hanlim Pharm, wAMD)

Competitors

Classification
Lucentis
Eylea
Vabysmo
AL101-AMD

Company

Genentech

Regeneron

Roche

AngioLab

Active ingredient

Ranibizumab

Aflibercept

Faricimab-svoa

ALS-L1023

Mechanism

Anti-VEGF antibody fragment

Fusion Protein of VEGFR

VEGF-A and Angiopoietin
2 inhibition

VEGF, bFGF, PDGF, MMPs inhibition

Side effect

Increased risk of stroke,
Vision change,
Pain in the eyes,
Red eye

Increased risk of stroke,
Vision change,
Pain in the eyes,
Red eye

Conjunctival hemorrhage,
Cataracts,
Bloody eye

No adverse effects

Remarks

FDA Approved(2006)
Direct injection into the eye
(Every 4 weeks)

FDA Approved(2011)
Direct injection into the eye
(Every 8 weeks)

FDA Approved(2022)
Direct injection into the eye
(Every 16 weeks)

Orally administered

03
AL101-MASH

Background of
Development

  • MASH is the most common chronic liver disease globally and is the fastest growing reason for liver transplants

  • Despite a major unmet need for drugs during the treatment of MASH, there are still no approved MASH drug in the market
Development Objective

  • Suppress lipid accumulation in the liver by inhibiting angiogenesis

  • Protect liver cells from injury by inhibiting the activation of IL-6 and NO through an anti-inflammatory mechanism

  • Improve fibrosis of liver cells through the regulation of produced collagen matrix by inhibiting MMP activity


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Summary of
Product

  • AL101-MASH regulates and cures the etiology of MASH directly through the suppression of fat accumulation, anti-inflammatory activity, and prevention of fibrosis by inhibiting the MMP

  • AL101-MASH Phase 2a clinical trial completed

04
AL102-PDT

Background of
Development

  • Periodontitis is the most common cause of adult tooth loss
Development Objective

  • Activity of Matrix Metalloproteinase (MMP) in the periodontal tissue is principally induced as a response to the persistent bacterial infection

  • MMPs start a process that results in deeper pockets and bone destruction

  • MMP inhibitors can protect periodontal ligaments and alveolar bone (tooth loss)


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Summary of
Product

  • AL102-PDT is a botanical drug that inhibits tooth loss by inhibiting MMP-1, -8, -9, and -13

  • The efficacy of AL102-PDT was proven in ligature-induced periodontitis examined in beagle dogs

  • The efficacy is better than that of Doxycycline, a commercial MMP inhibitor, which FDA approved for periodontitis

  • AL102-PDT Phase 2 clinical trial completed

05
AL101-OME

Background of
Development

  • Otitis Media with Effusion (OME) is the most common cause of hearing loss

  • No drug is available as of now
Development Objective

  • Angiogenesis inhibitors play a role in reducing the amount of effusion

  • VEGF and MMP, the important factors of OME, are effectively inhibited


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Summary of Product

  • Orally administered and safe, when compared with currently implemented treatments such as eardrum incision or ventilation system insertion

  • Showed efficacy in an animal disease model

  • AL101-OME Phase 2a clinical trial completed

06
AL101-ROSA

Background of
Development

  • Rosacea is a common skin condition that causes flushing or long-term redness on face. There's no cure for rosacea.
Development Objective

  • Angiogenesis inhibitors play a role in improving the disease condition

  • VEGF and MMP activities are inhibited

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Summary of Product

  • Showed efficacy in an animal disease model

07
AL101-PSO

Background of
Development

  • Number of patients with Psoriasis accounts for 2~3% of the total population and has been increasing sharply

  • Antibody drugs which are quite expensive dominate the market today
Development Objective

  • Angiogenesis inhibitors play a role in improving the disease condition

  • VEGF and MMP activities are inhibited
Summary of Product

  • Orally administered and safe, and has price competitiveness

  • Showed efficacy in an animal disease model

08
AL201-AB

Background of
Development

  • Current antibody drugs for wet AMD only target VEGF, which results in developing resistance in patients
Development Objective

  • New dual inhibitor which targets not only VEGFR1 but also VEGFR2
Summary of Product

  • Can be used for patients with resistance for the current antibody drugs as single-dose or combination therapy