바이오스펙테이터

by Jongwon Jang

The oral medication for Infantile spasms(IS) is in phase 2 clinical trials in Korea and the US, and the IV medication for Status epilepticus(SE) is in phase 1 clinical trials in the US. The company ha

Bio-Pharm Solutions Co., Ltd. has expanded its clinical pipelines from infantile spasms(IS) to status epilepticus(SE) and Alzheimer’s disease. Based on the performance of its first pipeline, an infantile spasms drug, BIo-Pharm Solutions is currently planning to capitalize through an IPO to advance other clinical development projects.

BioSpectator recently sat down with Dr. Yong Moon Choi, CEO of Bio-Pharm Solutions, to learn about the company’s pipelines and it’s strategies of specializing in development of drugs for treating CNS and Rare diseases.

Dr. Choi started his career as a research fellow at Richard B. Wetherill Laboratory of Purdue University under Prof. Herbert C. Brown, a Nobel Laureate in 1979, and he actively engaged in the development of Felbatol (felbamate), an epilepsy drug at Carter-Wallace, Inc.

With his extensive experience in drug development, he joined SK, formerly Yukong Ltd. in 1993 and established SK Biopharmaceuticals through which he led the design, discovery and development of various new drugs.

This includes the Sunosi (solriamfetol), for sleep disorders and Xcopri (cenobamate) for epilepsy, which has been approved last year by the US FDA.

In 2008, he found Bio-Pharm Solutions to specialize on epilepsy drugs focused on rare diseases and various other drugs to treat Central nervous system conditions to be ahead of the market.

Bio-Pharm Solutions’ first pipeline, ‘JBPOS0101,’ is a drug for infantile spasms.

The safety study of JBPOS0101 conducted under US FDA IND and has been confirmed through the phase 1 clinical trial in Canada. It received approval for the phase 2 clinical trial in the US (April) and in Korea (November) last year. The clinical trial is currently underway.

JBPOS0101 controls the occurrence of spasms directly and indirectly and it works on the mGluR family receptor, and also other unknown multiple mechanism. Unlike other existing drugs, it directly works on the ion channel related to the mode of action, and as a result, it has a low probability of developing tolerance and has a wider therapeutic coverage, according to BIo-Pharm Solutions.

In 2017, JBPOS0101 was approved for the Orphan Drug Designation (ODD) program by the US FDA.

"JBPOS0101 is a third-generation drug following Felbamate and Carisbamate. It excels both of the first- and second-generation drugs in terms of safety and efficacy," said Dr. Yong Moon Choi. "We are planning on global technology transfer after confirmation of its powerful efficacy through the phase 2 clinical trial.”

Bio-Pharm Solutions’ second pipeline is a Status epilepticus (SE) drug which is currently in the phase 1 clinical trial (intravenous injection toxicity study) in the US. It obtained ODD status from the US FDA in 2016.

While the Infantile spasms drug is administered orally, the Status epilepticus (SE) drug works via intravenous injection

Bio-Pharm Solutions, in particular, is conducting a study on maximizing the dose of the Status epilepticus (SE) drug to enable expansion to various indications. “We are verifying its safety by increasing the dose carefully for general epilepsy treatment," said Dr. Choi. "In the phase 2 clinical trial, it can be expanded to Lennox-Gastaut syndrome (LGS), Dravet syndrome, Refractory status epilepticus (RSE), etc."

In addition, Bio-Pharm Solutions is planning to develop an oral medication for Alzheimer’s disease through a new clinical pipeline. Currently, the company has completed the pre-clinical studies and will enter the phase 2 clinical trial in the US this year. "We have confirmed that our epilepsy drug candidate prevents the death of neurons in neurodegenerative diseases like Alzheimer’s disease and also reduces tau and amyloid β," said Dr. Choi. "We expect it will work for Alzheimer’s disease, Parkinson’s disease and certain pains."

Bio-Pharm Solutions published a paper about Alzheimer’s disease in the US, and is preparing one for Parkinson’s disease.

The company has been conducting R&D with the support of Chairman Hang Duk Kim of JB Corp., who has served as CEO of SK (Yukong) and vice-chairman of SK Group and to accelerate its R&D, Bio-Pharm Solutions is working on its IPO plan.

Bio-Pharm Solutions’ cost-effective development with high drug price strategy attracts the interest of strong global pharmaceutical companies.

“We have come all the way by developing medications for Rare diseases that can be commercialized with shorter time-to-market through the fast track," said Dr. Yong Moon Choi. "Based on the verification of the global clinical efficacy of the Infantile Spasms medication, we are planning to go public in Korea in the next 2 to 3 years and use the funds raised through IPO to engage in clinical development of multiple pipelines at the same time..”