buspirone/zolmitriptan (JM-010) / Bukwang Pharma - LARVOL DELTA

Open-Label Extension Study of ASTORIA (clinicaltrials.gov) - P2 | N=6 | Terminated | Sponsor: Contera Pharma A/S | N=80 ➔ 6 | Trial completion date: Oct 2024 ➔ Jun 2024 | Not yet recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ May 2024; The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Movement Disorders • Parkinson's Disease

Buspirone/zolmitriptan combination exerts synergistic reduction in dyskinesia without worsening Parkinson disease motor symptomatology (MDS Congress 2024) - P2 | "In this short, proof-of-concept pilot study, addition of buspirone/zolmitriptan to the patients PD medication regimen significantly reduced LID severity without worsening Parkinsonian motor function. The buspirone/zolmitriptan oral formulation (JM-010) has been modified in ongoing multi-center clinical trials investigating PD patients with LID (in the EU: NCT03956979; in the US: NCT04377945)."

CNS Disorders • Parkinson's Disease

ASTORIA: A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia (clinicaltrials.gov) - P2 | N=89 | Completed | Sponsor: Contera Pharma | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

SHINE: Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (clinicaltrials.gov) - P2 | N=41 | Terminated | Sponsor: Bukwang Pharmaceutical | N=148 ➔ 41 | Trial completion date: Jan 2025 ➔ Feb 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2025 ➔ Feb 2024; Business reasons

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Movement Disorders • Parkinson's Disease

Bukwang Pharma halts JM-010 clinical trials after setback (Korea Biomedical Review) - P2 | N=81 | ASTORIA (NCT03956979) | Sponsor: Contera Pharma | "Bukwang Pharmaceuticals announced Thursday the termination of its U.S. clinical trials for JM-010, a drug intended to treat dyskinesia in Parkinson's disease patients. This follows Contera Pharma's failure to meet primary efficacy endpoints in a phase 2b trial in Europe...In an online briefing, Bukwang CEO Lee Jae-young explained that the company has decided to halt the U.S. clinical trials as well due to the failed European phase 2 b trial...'While we observed a statistical difference in the pre-and post-treatment results of JM-010, it did not show a significant difference compared to the placebo group.'"

P2 data • Trial termination • CNS Disorders • Parkinson's Disease

ASTORIA: A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: Contera Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

SHINE: Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (clinicaltrials.gov) - P2 | N=148 | Active, not recruiting | Sponsor: Bukwang Pharmaceutical | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Buspirone and Zolmitriptan Combination for Dyskinesia: A Randomized, Controlled, Crossover Study. (PubMed, Mov Disord) - P2 | "In this proof-of-concept study, addition of buspirone/zolmitriptan to the patients' PD medication regimen significantly reduced dyskinesia severity without worsening motor function."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Contera Pharma completes final patient registration for Phase 2 clinical trial for Parkinson's dyskinesia treatment [Google transaltion] (HIT News) - "Bukwang Pharmaceutical...is the owner of 'ASTORIA' of its Danish subsidiary, Contera Pharma A/S. It was announced on the 18th that the last patient in the late phase 2 clinical trial was registered. The clinical trial is being conducted to evaluate the effectiveness of 'JM-010 (development code name), a candidate substance for the treatment of Parkinson's disease dyskinesia. According to the company, the topline results of the ASTORIA exam are expected to be released in the second half of this year."

Enrollment closed • P2 data • CNS Disorders • Parkinson's Disease

Contera Pharma's 'JM-010' expanded clinical trials in Europe [Google translation] (PRESS9) - "Bukwang Pharmaceutical's subsidiary, Denmark's Contera Pharma, has expanded its European clinical center for Parkinson's dyskinesia treatment. It is solved for the purpose of speeding up clinical progress by registering patients from various institutions. According to the EU Clinical Trials Register, a European clinical trial site, on the 2nd, Contera Pharma received approval for phase 2 clinical trial of 'JM-010' from the Slovak Drug Regulatory Authority on the 28th of last month."

Trial status • CNS Disorders • Parkinson's Disease

SHINE: Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (clinicaltrials.gov) - P2 | N=188 | Recruiting | Sponsor: Bukwang Pharmaceutical | Trial completion date: Dec 2022 ➔ Jul 2024 | Trial primary completion date: Dec 2022 ➔ Jul 2024

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Bukwang Pharmaceutical “Expansion of JM-010 Phase 2 clinical center for Parkinson’s disease dyskinesia treatment” [Google translation] (Health Korea News) - "Bukwang Pharmaceutical announced...that it would add a Korean clinical institution related to the European phase 2 clinical trial of JM-010, its Parkinson's disease dyskinesia treatment. A European clinical trial of JM-010 is ongoing to evaluate the therapeutic effect of JM-010 on dyskinesias in Parkinson's patients in France, Germany, Italy, and Spain. The company explained that it submitted an IND (clinical trial plan) to add a Korean clinical institution to the Korean Ministry of Food and Drug Safety to speed up clinical trials and that it was approved on November 7. Five hospitals were added to this clinical trial: Gil Hospital, Inje University Sanggye Paik Hospital, Yonsei University College of Medicine Severance Hospital, Korea University College of Medicine Ansan Hospital, and Korea University College of Medicine Guro Hospital."

Trial status • CNS Disorders • Movement Disorders • Parkinson's Disease

Open-Label Extension Study of ASTORIA (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Contera Pharma A/S

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Synergistic effect of serotonin 1A and serotonin 1B/D receptor agonists in the treatment of L-DOPA-induced dyskinesia in 6-hydroxydopamine-lesioned rats. (PubMed, Exp Neurol) - "The strong anti-dyskinetic effect found with combined 5-HT1A and 5-HT1B/D agonism renders buspirone and zolmitriptan together a meaningful treatment for LID in PD."

Journal • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

ASTORIA: A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia (clinicaltrials.gov) - P2 | N=81 | Recruiting | Sponsor: Contera Pharma | Trial completion date: Mar 2022 ➔ Dec 2023 | Trial primary completion date: Mar 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

ASTORIA: A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia (clinicaltrials.gov) - P2; N=81; Recruiting; Sponsor: Contera Pharma; Trial primary completion date: Dec 2021 ➔ Mar 2022

Clinical • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Bukwang Pharm, initiated the first patient administration of ’JM-010’ in the US phase 2 clinical trial (Pharm News) - "Bukwang Pharm announced on the 29th that it has been administered to patients for the first phase 2 clinical trial of'JM-010', a treatment for Parkinson's dyskinesia, which is currently in progress in the United States...secures the results of interim analysis in 2022 and expects the completion of clinical trials in 2023,'..."

P2 data • Trial completion date • Trial status • CNS Disorders • Parkinson's Disease

SHINE: Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (clinicaltrials.gov) - P2; N=188; Recruiting; Sponsor: Bukwang Pharmaceutical; Initiation date: Jan 2021 ➔ Apr 2021

Clinical • Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

SHINE: Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (clinicaltrials.gov) - P2; N=188; Recruiting; Sponsor: Bukwang Pharmaceutical; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

ASTORIA: A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiA (clinicaltrials.gov) - P2; N=81; Recruiting; Sponsor: Contera Pharma; Trial completion date: Jun 2021 ➔ Mar 2022; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

SHINE: Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (clinicaltrials.gov) - P2; N=188; Not yet recruiting; Sponsor: Bukwang Pharmaceutical; Initiation date: Jun 2020 ➔ Dec 2020; Trial primary completion date: Aug 2022 ➔ Dec 2022

Clinical • Trial initiation date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Bukwang Pharm ’Conterapharma Series B 51 billion won investment payment completed’ [Google translation] (Money Today Network (MTN)) - "The payment of investment in Series B 51 billion won by Conterama, a subsidiary of Bukwang Pharm, is completed. It is expected that speed will accelerate in clinical trials conducted by Conterama....The funding is expected to accelerate the phase 2 trial of JM-010, a treatment for dyskinesia related to Parkinson's disease in Europe and the United States."

Financing • CNS Disorders • Parkinson's Disease

SHINE: Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (clinicaltrials.gov) - P2; N=188; Not yet recruiting; Sponsor: Bukwang Pharmaceutical

Clinical • New P2 trial

Bukwang Pharm, Parkinson's 'greatness' to global innovative new drugs treating side effects [Google translation] (Maekyung Media Group) - "Conterama's JM-010 is currently in Phase 2 clinical trials in Europe and has been approved for Phase 2 clinical trials in the United States. In particular, there are no side effects, and it does not affect the efficacy of levodopa."

Trial status

Bukwang's dyskinesia treatment gets FDA nod for P2 [sic] trials (Korea Biomedical Review) - "The U.S. Food and Drug Administration has recently approved the phase 2 clinical trial of Bukwang Pharmaceutical's dyskinesia treatment, JM-010....Contera Pharma will conduct the clinical trials in 190 patients at about 30 institutions in the U.S., who showed side effects of dyskinesia caused by the intake of Levodopa, to evaluate the safety and effectiveness of JM-010."

New P2 trial