The global prevalence and attack rates of gout are on the rise, which likely owes to aging, obesity, and changing diets, etc. It is expected that, as of 2022, approximately 35 million patients have been diagnosed with gout, including 10 million and 14 million in U.S. and China respectively. Gout is a type of arthritis that produces joint pains and edema, caused by an overload of uric acid. Uric acid is the substance formed after the food we’ve eaten is digested. It usually remains in the blood until it is released through urine. In the case of gout patients, the blood contains an excessive level of uric acid, which may crystallize due to accumulated uric acid  and leave deposits within the joints, becoming the cause of inflammation and extremely pain.

‘Tigulixostat’ is LG Chem’s new gout drug developed in-house, a once-daily oral medication which inhibits ‘Xantine Oxidase (XO),’ an enzyme that produces uric acid, the main cause of gout. Its U.S. Phase 2 clinical trial results have confirmed the possibility of a new drug differentiated from existing treatments with rapid and strong uric acid lowering effect, demonstrating safety similar to that of the placebo group. As of September 2022, LG Chem submitted IND application for two phase 3 trials for the new gout drug, and these clinical trials are currently underway.

LG Chem’s new gout drug is blowing a fresh breeze into the gout treatment market! Let’s hear more from Senior Jang Young-hwan, responsible for the clinical trial of Tigulixostat.

Hello! Could you introduce yourself?

Hello, I’m Jang Younghwan, representing LG Chem Life Sciences Company, Clinical Development CSM2 Team. I joined LG Chem (Former LG Life Sciences) in 2011, and since then I’ve been a part of the clinical development team, taking care of clinical trials for 12 years.

What responsibility does the CSM2 team have?

LG Chem Life Sciences Company develops treatments for various diseases. In particular, the CSM2 team is responsible for clinical trials of metabolic diseases such as diabetes, obesity, or gout, and vaccines. Developing new drugs requires a number of clinical trials. My team organizes and manages the clinical trials to make sure they are completed within the schedule and budget without an issue.

LG Chem’s new gout drug has entered Phase 3 clinical trial. Could you explain its significance?

It’s a common sense that developing a new drug takes a long time and a series of steps to make through. To put it roughly, the process is divided into three stages: R&D, clinical trial, and approval. Most new drugs experience a setback before Phase 3 clinical trial. However, LG Chem’s new gout drug has made it past Phase 3 clinical trial, which is the final stage before gaining approval. Say new drug development is an Olympic game. Entering Phase 3 trial is the same as passing a preliminary match and advancing to the finals. The final match is when the Olympic medal winners are decided. LG Chem’s new gout drug is now facing its final, Phase 3 clinical trial.
For now, the team’s priority is doing our best to complete the final Phase 3 clinical trial. After that follows the challenge of gaining approval from the judges. The judgment depends highly on the clinical trials results, however, the FDA’s evaluation about our clinical tests is what eventually approves the launch of our new drug.

What competency does LG Chem hold in the global clinical trial?

It’s the same reason that led me to LG Chem’s Life Sciences Company. Among other Korea-based pharmaceutical companies, LG Chem holds the highest possibility to develop new drugs. LG Chem’s Life Sciences Company has high competency and potential to go beyond Korea and become a global pharmaceutical company.

The key factor in developing new drugs is the capacity and experience of research and development. LG Chem has been investing in new drugs since long in the past. In particular, we have a competitive edge in terms of the R&D capacity. As for the experience, LG Chem has less R&D experience in new drug development compared to other global companies. However, this can be compensated by the recent hiring of new members with experience in new drugs and solid experiences in certain fields of R&D that we have long been conducting. Therefore, I can be confident about our competency in the global pharmaceutical market.

What’s the biggest challenge of gout new drug clinical trial?

Among others, the biggest challenge is to register the required number of patients within the schedule. In developing new drugs, time equals money. So it’s really important that we gain approval as soon as possible and launch the new drug. Recruiting patients affects the schedule of clinical trial the most.

Currently, about 320 hospitals in 21 countries have enrolled patients or are planning to enroll gout patients. It’d be ideal if all hospitals can enroll the targeted number of patients within our schedule, but we always face unexpected difficulties and variables. So our team takes time to consider and discuss how to solve such matters and carry out patient enrollment as planned, and as effectively as possible.

What is your pride about LG Chem’s Life Sciences Company?

New drug development is like cogwheels that need to engage with one another. Without the cooperation of all departments, it’s impossible to come up with a new drug. LG Chem’s Life Sciences Company boasts great teamwork between organizations, and all departments work together at a fast pace in each stage.

Another notable feature of our company is the quick response to different crisis situations and variables. The process of developing new drugs involve many unexpected issues and variables, and it is required that we make a quick response to these challenges. LG Chem Life Sciences Company can react to these situations in a flexible manner.

What is your future goal in LG Chem?

My goal is to complete the clinical trial and gain approval for the gout drug to go on sale. I hope to see actual gout patients take our treatment. If our gout drug could be prescribed for many patients and help them improve their symptoms, it would be such a rewarding moment for all our hard works.

I can’t be too definite yet, but I also hope to experience developing new drugs for a rare disease. There’s a lack of drugs for rare diseases due to the difficulties in developing them and their marketability. If a pharmaceutical company like us can jump into the R&D of rare disease treatments, that itself could give a flame of hope for those minority of patients.

LG Chem Life Sciences Company is pushing forward the Phase 3 clinical trial of gout drug that can be applied to gout patients first and foremost! Next time, we’ll return with the story of the development process of Tigulixostat and the efforts we made to stabilize its commercialization. Please look forward to LG Chem’s Gout Drug Development History Interview Volume 2!