1. OliX Pharmaceuticals, Inc.

2. History

3. Pipeline

4. Reference

5. References

OliX Pharmaceuticals, Inc.

OliX Pharmaceuticals Inc. is a clinical stage pharmaceutical company developing therapeutics against a variety of disorders by down-regulating expression of disease-causing genes, based on its own proprietary RNAi technology. It secures the technology of cell-penetrating asymmetric small interfering RNA (cp-asiRNA) which can be delivered to target cells/tissues without the aid of any delivery vehicle, along with reduced non-specific effects over conventional siRNA. The company is currently developing novel therapeutic programs for treatment of various diseases with high unmet medical needs, including hypertrophic scar, dry form of age-related macular degeneration (AMD), subretinal fibrosis, and idiopathic pulmonary fibrosis (IPF).

History

2018

Jul Public offering at Korean Securities Dealers Automated Quotations (KOSDAQ)

May CTA approval for phase 1 clinical trial in UK

May Completion of OLX101 phase 1 clinical trial in Korea

Apr Agreement on collaborative research of AMD treatment with Ildong Pharmaceutical Co. Ltd.

2017

Sep “A” grade from Technology Evaluation (to be entitled for public offering at KOSDAQ)

May lasiRNA patent registered in USA

Feb IND approval of anti-scarring therapeutics (OLX101) for phase 1 clinical trial in Korea

2016

Jul Publication of hypertrophic scar treatment in Journal of Investigative Dermatology

Mar OLX102 registration for skin brightening in ICID

2015

Jul Technology Innovative Small-to-Medium Enterprise (INNO-BIZ) certified by Small and Medium Business Administration in Korea

Apr "Technical development support project" grant awarded from Korean Small and Medium Business Administration for the development of atopic dermatitis therapeutics (OLX103)

2014

Nov "New Drug Development Program" grant awarded from Korea Drug Development Fund for the development of anti-scarring therapeutics (OLX101)

Sep "International R&D Collaboration Program" grant awarded from Korean Ministry of Health and Welfare for development of Idiopathic Pulmonary Fibrosis (IPF) therapeutics (OLX201)

Sep Company name changed to OliX Pharmaceuticals Inc.

2013

Nov Licensed out Asian rights of anti-scarring program (OLX101) to Hugel Inc.

Jun asiRNA patent registered in Australia and Europe

May Patent application of cell penetrating siRNA (Korea, PCT, USA, Europe, China, and Japan)

2011

Dec Developed cp-asiRNA, a cell-penetrating RNAi technology, and initiated anti-scar therapeutic program (BMT101)

2010

Feb BMT (Biomolecular Therapeutics) Inc. founded

Pipeline

1) OLX101 (hypertrophic scar)

With OliX’s proprietary RNAi platform technology, OLX101 program is currently in clinical trial in Korea and UK, for the treatment of hypertrophic scar. Scars are common during the wound healing process; however, a hypertrophic scar is a result of an abnormal response to skin injury and surgery, due to excessive level of fibrosis on the affected area of skin. While 39 - 68% of post-operative patients develop hypertrophic scar, there are no approved prescription drug products yet.

In collaboration with Hugel Inc., phase 1 study with OLX10100 (a candidate molecule for OLX101 program) in Korea was completed successfully without any significant safety issues in May 2018. Also, OliX is conducting another phase 1 clinical trial in UK after receiving clinical trial authorization (CTA) with OLX10100, from Medicines and Healthcare products Regulatory Agency (MHRA) in May 2018.

The global scar treatment market was valued at $ 4.8 billion in 2017 and is projected to reach approximately $ 6.9 billion by 2021 at CAGR of 9.6%. Increasing awareness among people to improve appearance and fueling demand for aesthetic procedures, OLX10100 could be a promising therapeutic option in the market with its competitiveness in the efficacy and cost-efficiency.

2) OLX201 (idiopathic pulmonary fibrosis, IPF)

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive and most deadly type of interstitial lung diseases. More than 50% of patients die within 3 years of diagnosis, with the 5-year survival rate of only 20-40%. The currently approved IPF drugs are still limited by their insufficient efficacy and side effects. The current market size of IPF is about $ 1.3 billion in 2017 and is expected to grow as potential new therapies successfully address key limitations of existing marketed products. With OLX201 program to develop the treatment of IPF, OliX completed to verify the efficacy in animal model in collaboration with A*STAR in Singapore, preparing the optimized formulation. A phase 1 clinical study for OLX201 is planned to begin in 2020.

3) OLX301 (age-related macular degeneration, AMD)

There are no approved therapies for dry age-related macular degeneration (AMD) and subretinal fibrosis. Working with Prof. Jayakrishna Ambati in University of Virginia, OLX301A and OLX301D programs are under preclinical studies to treat these conditions with high unmet medical needs. Especially, OLX301A is expected to be a promising first-in class drug that provides therapeutic effects not only in dry AMD but also in wet AMD.

Based on OliX’s RNAi platform technology, OliX is actively pursuing to further expand its fibrotic disease pipeline and other clinical indications, primarily focusing on readily accessible target organs, such as skin, lung and eye.

Reference

Hwang J, Chang C, Kim JH, Oh CT, Lee HN, et al. Development of Cell-Penetrating

Asymmetric Interfering RNA Targeting Connective Tissue Growth Factor. J Inv Dermatol 2016;136:2305-2313

OliX Pharmaceuticals receives Clinical Trial Authorization in the UK to initiate Phase I study with OLX10010, an anti-scar RNAi therapeutics. PR Newswire. May 29, 2018

A phase 1, randomized, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic profiles of OLX10010 in healthy subjects compared to placebo. ISRCTN64317949

A Study to Evaluate Safety and PK Profiles of OLX10010 in Healthy Subjects. NCT03569267 (ClinicalTrials.gov)

References

• The Three Shades
• The Three Sisters (1970 TV drama)
• The Three Sisters (1970 TV film)
• The Three Sisters (Lake Huron)
• The Three Sisters (Temagami)
• The Three Snake-leaves
• The Three Sounds Play Jazz on Broadway
• The Three Sources and Three Component Parts of Marxism
• The Three Stooges 75th Anniversary Special
• The Three Stooges Greatest Hits
• The Three Sui Quash the Demon's Revolt
• The Three Sui Quash the Demons’ Revolt
• The Three Sui Quash the Demon’s Revolt
• The Three Sui Quell the Demons' Revolt
• The Three Sui Quell the Demon's Revolt
• The Three Sui Quell the Demons’ Revolt
• The Three Sui Quell the Demon’s Revolt
• The Three Tenors Paris
• The Three Tenors Paris 1998
• The Three Tenors: Paris 1998
• The Three Theives (Graphic Novel series)
• "The Three" & "The Two"
• The Three & The Two
• The Three Thieves
• The Three Tons of Joy