PHP-201

PHP-201 (Sovesudil)PH PHARMA

PHP-201 (also known as sovesudil) belongs to a novel class of molecules called Rho kinase (ROCK) inhibitors. ROCK inhibitors have a proposed mechanism of action where it relaxes the trabecular meshwork and subsequently increases aqueous humor outflow. The increase in aqueous humor outflow lowers intra-ocular pressure (IOP) and this is essential for treatments of Primary Open Angle Glaucoma (POAG) as well as normal tension glaucoma (NTG) which has a very high prevalence rate in key Asian markets. Sovesudil’s unique ‘Localized Drug Action’ and preservative free formulation minimizes systemic exposure and topical side effects, that are commonly seen with ROCK inhibitors, prostaglandin analogues, and other anti-glaucoma drugs currently on the market. Specifically, there are significantly fewer incidences of hyperaemia compared to leading therapies. This alone can improve compliance and overall therapeutic benefits over current approaches.

Development Status

  • pH Pharma had acquired sovesudil from AMAKEM NV in Feb 2016, completed Phase 1b and 2b clinical trials, and have submitted Phase 3 IND in Korea.
  • The Phase 1b clinical trial evaluated the pharmacokinetics, pharmacodynamics, safety and tolerability of sovesudil in healthy Korean and Japanese subjects.
  • The Phase 2b clinical trial evaluated the optimal dose for efficacy and safety of sovesudil as a monotherapy in normal-tension glaucoma (NTG) patients.
  • pH Pharma plans to conduct Phase 3 clinical trials for sovesudil in Korea, China and Japan

What is normal-tension glaucoma?

Normal-tension glaucoma (NTG) is a form of glaucoma in which damage occurs to the optic nerve without eye pressure exceeding the normal range. Population based glaucoma study reported that NTG accounts for 76% of Asian patients with POAG.

NTG Proportion in Asian Countries (%)

Clinical Advisory Board

Ki Ho Park

M.D., Ph.D.

  • Professor and Chairman, Department of Ophthalmology, Seoul National University Hospital
  • Board of Governor, World Glaucoma Association (WGA)
  • Board Member, Asia Pacific Glaucoma Society (APGS)
  • Secretary General, Asian Angle Closure Glaucoma Blub (AACGC)

Tetsuya Yamamoto

M.D., Ph.D.

  • Professor & Chairman, Department of Ophthalmology, Gifu University School of Medicine
  • President, Japan Glaucoma Society (JGS)
  • Board Member, Japanese Ophthalmological Society (JOS)
  • Board Member, Asia Pacific Glaucoma Society (APGS)
  • Member, Glaucoma Research Society (GRS)

Tin Aung

MMed(Ophth),FRCS(Ed),FRCOchth(UK), FAMS, Ph.D(Lond)

  • Professor, Department of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore
  • Former Chair, Organisation Transformation Committee, Singapore National Eye Centre & Singapore Eye Research Institute 
  • Former President, World Glaucoma Association 
  • Chairman, National Medical Research Council CS-IRG Local Review Panel

Paul Kaufman

M.D.

  • Professor and Chairman, Department of Ophthalmology & Visual Sciences, University of Wisconsin School of Medicine and Public Health
  • Past President and Executive Vice President, Association for Research in Vision and Ophthalmology (ARVO)
  • Past President, International Society for Eye Research (ISER)

Keith Barton

M.D.

  • Consultant Ophthalmologist and Glaucoma Specialist, Moorfields Eye Hospital
  • Honorary Reader, UCL Institute of Ophthalmology
  • Steering Committee, Primary Tube Versus Trabeculectomy (PTVT) study
  • Chief Investigator, Corneal Ancillary Study to the PTVT study
  • Trial Management Committee, Treatment of Advanced Glaucoma (TAGS) and Lasers in Glaucoma and Ocular Hypertension (LIGHT) studies

Ingeborg Stalmans

M.D., Ph.D.

  • Professor, Department of Ophthalmology, Catholic University of Leuven (KU Leuven)
  • Member, European Glaucoma Society (EGS) Special Interest Groups on Neuroprotection and Ocular Blood Flow
  • Program Secretary, EVER Glaucoma Section