JBPOS0101 / Bio-Pharm Solutions, Zhejiang Jingxin Pharma - LARVOL DELTA

Pharmacokinetic drug-drug interactions of JBPOS0101 mediated by cytochrome P450 3A4 and UDP-glucuronosyltransferases. (PubMed, Clin Transl Sci) - "As co-medication of JBPOS0101 and carbamazepine (CBZ) is expected in clinical settings, drug-drug interactions (DDIs) between them should be determined. This study aimed to investigate pharmacokinetic (PK) interactions of JBPOS0101 influenced by CYP3A4 and UGTs using midazolam (MDZ) and CBZ...The ability of JBPOS0101 to similarly modulate gut CYP3A4 activity will require further evaluation. Co-administration of multiple doses of JBPOS0101 and CBZ did not significantly alter CBZ pharmacokinetics, but the clinical impact of decreased systemic exposure of JBPOS0101 by CBZ should be further considered."

Journal • PK/PD data • CYP3A4

The Efficacy of New Chemical Entity JBPOS0101 in Status Epilepticus and the Correlation Between Nonclinical Data and Clinical Outcomes in Phase IIa Studies (AES 2023) - " In nonclinical studies, SE was induced in rats using lithium and pilocarpine and EEG signals were monitored for ten hours...SE patients who failed first line lorazepam were administered JBPOS0101 together with second line levetiracetam... This data suggests that the efficacy of JBPOS0101 observed in nonclinical models appears to translate well to clinical settings, making JBPOS0101 a strong potential candidate for the treatment of refractory SE patients."

Clinical data • P2a data • Anesthesia • CNS Disorders • Epilepsy

Jingxin Pharmaceutical (002020.SZ): JBPOS0101 Capsule and JX7002 Injection Approved for Clinical Trials [Google translation] (Sina Corp) - "Jingxin Pharmaceutical (002020.SZ) announced that the company has received the 'Drug Clinical Trial Approval Notice' approved and issued by the State Food and Drug Administration for JBPOS0101 capsules and JX7002 injections. It is reported that JBPOS0101 capsules will be used in clinical trials for the treatment of focal epilepsy in adults."

New trial • CNS Disorders • Epilepsy

A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients (clinicaltrials.gov) - P2 | N=16 | Terminated | Sponsor: Bio-Pharm Solutions Co., Ltd. | N=35 ➔ 16 | Recruiting ➔ Terminated; Difficulty with patient recruitment due to COVID-19

Enrollment change • Trial termination • CNS Disorders

Biopharm Solutions, completed Phase 2a clinical trial for pediatric convulsions and epilepsy in adults [Google translation] (Korea Economic TV) - P2a | N=35 | NCT03976076 | Sponsor: Bio-Pharm Solutions Co., Ltd. | "Biopharm Solutions...announced...that it has recently completed phase 2a clinical trials for epilepsy drug candidate (JBPOS0101) in pediatric spasms and adult epilepsy. Biopharmaceuticals has completed the photo seizure response suppression (PPR) test, which is the phase 2a proof-of-concept (POC) stage, of 'JBPOS0101' in relation to adult epilepsy, and has serious abnormalities even when 600 mg of the substance is administered to clinical patients. He explained that there was no reaction....a phase 2b clinical trial for Lennox Gassto syndrome (LGS) in the first quarter of next year."

New P2b trial • P2a data • Trial completion • CNS Disorders • Epilepsy

Biopharm Solutions, Hana Financial Investment selected as the organizer of the IPO [Google Translation] (Hankyung) - "Biopharm Solutions announced...that it had selected Hana Financial Investment as the lead company for listing on the KOSDAQ market. It plans to complete the pre-IPO, which it has been promoting with Hana Financial Investment at the beginning of the year, and submit a request for preliminary examination for listing as early as this year...The main candidate substance (pipeline) is 'JBPOS0101', a drug candidate for epilepsy (epileptic)...It has also received approval from the Ministry of Food and Drug Safety for a rare disease, Status Epilepticus, and is in the process of phase 2 in Korea."

Commercial • New P2 trial • CNS Disorders • Epilepsy

Ministry of Food and Drug Safety approved 3 clinical trials including epilepsy treatment [Google translation] (Health Korea News) - "The Ministry of Food and Drug Safety approved three clinical trials...including epilepsy treatment. Biopharm Solutions will conduct a phase 1 clinical trial of 'JBPOS0101', an epilepsy treatment, at Seoul National University Hospital. To evaluate the effect of 'JBPOS0101' on the pharmacokinetics of midazolam and the interaction between karmazepine and 'JBPOS0101' in 16 healthy subjects."

New P1 trial • CNS Disorders • Epilepsy

Jingxin in-licensing epilepsy drug from Bio-Pharm Solutions in $40M deal (Bioworld) - "Zhejiang Jingxin Pharmaceutical Co. Ltd. has in-licensed JBPOS-0101, a class I new drug for epilepsy, from Bio-Pharm Solutions Co. Ltd. for mainland China, Hong Kong, and Macau. The partnership could bring South Korea’s Bio-Pharm more than $40 million, including an up-front payment of $5 million, milestone payments of up to $35 million, and potential royalties on future sales."

Licensing / partnership • CNS Disorders • Epilepsy

Biofarm Solutions, approved for ’mGluR antagonist’ SE Korea Phase 2 [Google translation] (Biospectator) - "Biofarm Solutions (B-PS) announced on the 26th that it has received approval from the Ministry of Food and Drug Safety for phase 2 clinical trials for status epilepticus (SE) of the mGluR antagonist 'JBPOS0101'....This phase 2 clinical trial will be conducted at Seoul National University Hospital, Konkuk University Hospital, and Chungnam National University Hospital....Biofarm Solutions has completed phase 1 clinical trials for epileptic overlap in the United States using JBPOS0101, an intravenous formulation."

Non-US regulatory • Trial completion • CNS Disorders • Epilepsy

A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients (clinicaltrials.gov) - P2; N=35; Recruiting; Sponsor: Bio-Pharm Solutions Co., Ltd.; Trial completion date: Apr 2021 ➔ Mar 2022; Trial primary completion date: Apr 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date

JBPOS0101 regulates amyloid beta, tau, and glial cells in an Alzheimer's disease model. (PubMed, PLoS One) - "Furthermore, the elevation of reactive astrocytes and microglia in 5xFAD mice was attenuated in JBPOS0101-treated groups. These data suggest that JBPOS0101 may be a new drug candidate to lessen amyloid- and tau-related pathology by regulating glial cells."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy

JBPOS0101 attenuates amyloid-β accumulation and memory loss in a mouse model of Alzheimer's disease. (PubMed, Neuroreport) - "It showed a neuroprotective effect and prevented memory deficits in lithium-pilocarpine-induced status epilepticus rats. Moreover, the treatment of JBPOS0101 rescued the deficits in learning and memory in 5XFAD mice. These data suggest that JBPOS0101 could be a potential therapeutic drug candidate for AD."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Epilepsy • Tauopathies And Synucleinopathies

A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients (clinicaltrials.gov) - P2; N=35; Recruiting; Sponsor: Bio-Pharm Solutions Co., Ltd.; Not yet recruiting ➔ Recruiting; Trial completion date: Feb 2020 ➔ Apr 2021; Initiation date: Jul 2019 ➔ Mar 2019; Trial primary completion date: Feb 2020 ➔ Apr 2021

Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date