vodobatinib (SCC – 138) / Sun Pharma Advanced Research Company - LARVOL DELTA

PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706 (clinicaltrials.gov) - P2 | N=513 | Terminated | Sponsor: Sun Pharma Advanced Research Company Limited | Trial completion date: Mar 2024 ➔ Jun 2024 | Active, not recruiting ➔ Terminated; Terminated based on study outcomes

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

Insights into the management of Lewy body dementia: a scoping review. (PubMed, Ann Med Surg (Lond)) - "Donepezil, rivastigmine, memantine, and galantamine were the commonly used drugs for LBD. Together with that, levodopa, antipsychotics, armodafinil, piracetam, and traditional medications like yokukansan were also used, when indicated...Talking about recent advances in the treatment of LBD, various disease-modifying therapies like ambroxol, neflamapimod, irsenontrine, nilotinib, bosutinib, vodobatinib, clenbuterol, terazosin, elayta, fosgonimeton, and anle138b are emerging out...With the different pharmacological and nonpharmacological modalities we have for treatment of LBD, all of them offer symptomatic relief only. Being a degenerative disease, definite cure of the disease can only be possible with regenerative measures."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease

PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706 (clinicaltrials.gov) - P2 | N=506 | Active, not recruiting | Sponsor: Sun Pharma Advanced Research Company Limited | Recruiting ➔ Active, not recruiting

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

SPARC completes enrolment in PROSEEK, Phase 2 study of Vodobatinib in early Parkinson’s disease (ExpressPharma) - "Sun Pharma Advanced Research Company announced the completion of enrolment of 506 patients in a global, randomised, doubleblind, placebo-controlled Phase 2 study in patients with early Parkinson’s disease evaluating the safety and efficacy of Abl tyrosine kinase inhibition using K0706 (PROSEEK)."

Enrollment closed • CNS Disorders • Parkinson's Disease

PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706 (clinicaltrials.gov) - P2 | N=504 | Recruiting | Sponsor: Sun Pharma Advanced Research Company Limited | Trial completion date: May 2023 ➔ Mar 2024 | Trial primary completion date: May 2023 ➔ Mar 2024

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

Plasma and cerebrospinal fluid pharmacokinetics of vodobatinib, a neuroprotective c-Abl tyrosine kinase inhibitor for the treatment of Parkinson's disease. (PubMed, Parkinsonism Relat Disord) - "Based on achieved CSF concentrations, the potential for c-Abl inhibition in the brain is substantially higher with vodobatinib than with nilotinib. The CSF PK profile of vodobatinib is suitable for determining if c-Abl inhibition will be neuroprotective in PD patients."

Journal • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease • ABL1

Vodobatinib, a potent, orally bioavailable brain-penetrating inhibitor of c-Abl as a potential neuroprotective agent for the treatment of Parkinson’s Disease (MDS Congress 2022) - "Higher potency and efficient brain penetration of vodobatinib suggest that vodobatinib offers a better opportunity than nilotinib to test whether c-Abl inhibition ameliorates disease progression in PD."

CNS Disorders • Parkinson's Disease • ABL1

C-abl inhibitor, k0706/vodobatinib, protects dopaminergic neurons against α-synuclein preformed fibril induced neurodegeneration (Neuroscience 2021) - "These results suggest that the c-Abl inhibitor, K0706 may be beneficial as a disease modifying therapy in PD. K0706/vodobatinib is currently being evaluated in phase 2 clinical trial, ProSeek, in patients with early stage Parkinson's Disease.; Grant Support: Sun Pharma Advanced Research Company, Ltd"

CNS Disorders • Parkinson's Disease • ABL1

Novel BCR-ABL1 tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia. (PubMed, Expert Rev Hematol) - No abstract available

Journal • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

K0706 for Patients Diagnosed With Dementia With Lewy Bodies (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Georgetown University; Trial completion date: Aug 2021 ➔ Oct 2023; Trial primary completion date: Jan 2021 ➔ Jun 2023

Clinical • Clinical data • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

[VIRTUAL] Prevalence of Sars-Cov-2 Infection in Patients with Chronic Myeloid Leukemia (ASH 2020) - "Twenty pts were off TKI (post-alloSCT, n=12; in treatment free remission n=6; pregnancy=1 and intolerance n=1) and 141 were on active treatment (imatinib [n=41], dasatinib [n=38], nilotinib [n=23], bosutinib [n=21], asciminib [n=11], ponatinib [n=6] and K0706 [n=1])...The only patient with severe COVID-19 developed pneumonia requiring CPAP, was refractory to tocilizumab (anti-IL6), but recovered after starting ruxolitinib (JAK2-inhibitor)...Of note is the higher prevalence in the BAME community and underlines the potential role of socioeconomic factors in disease transmission. Expansion of this CML cohort and serial antibody testing in seropositive patients will provide further information regarding prevalence and durability of serological responses."

Clinical • Chronic Myeloid Leukemia • Fatigue • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Musculoskeletal Pain • Novel Coronavirus Disease • Oncology • Pain • Pneumonia • Respiratory Diseases • Solid Tumor • Thrombosis

PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706 (clinicaltrials.gov) - P2; N=504; Recruiting; Sponsor: Sun Pharma Advanced Research Company Limited; Trial completion date: Feb 2021 ➔ Mar 2023

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

K0706 for Patients Diagnosed With Dementia With Lewy Bodies (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Georgetown University; Active, not recruiting ➔ Recruiting

Clinical • Clinical data • Enrollment open • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

Hospitals San Roque participates in an investigation of a new drug for Parkinson's [Google translation] - "The Parkinson's and Disorders Unit of the Movement of San Roque University Hospitals...has been selected to participate in the second phase of an international investigation into a new drug to delay progression Parkinson's disease....This second phase consists of determining if the drug K0706 reduces the rate of progression in early stages of Parkinson's disease, as well as its safety and tolerability."

Enrollment open • CNS Disorders • Parkinson's Disease

Safety, Tolerability, Pharmacokinetics and Activity of K0706 (clinicaltrials.gov) - P1/2; N=303; Recruiting; Sponsor: Sun Pharma Advanced Research Company Limited; Trial completion date: Sep 2021 ➔ Aug 2026; Trial primary completion date: Mar 2020 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology