Anyone heard about this?
Note on *SPARC's Vodobatinib* for *Parkinson's Disease*:
SPARC, a pioneering force in the pharmaceutical arena, is making significant strides with its flagship *Neurological* program asset, Vodobatinib. Currently, Vodobatinib is undergoing trials for three critical indications under the c-ABL inhibitor mechanism of action: *Parkinson's Disease, Lewy Body Dementia, and Alzheimer's Disease*. Additionally, in the *Oncological* program, the same asset is being tested under the BCR-ABL inhibitor mechanism of action for the treatment of *Refractory Chronic Myelogenous Leukaemia*.
SPARC recognizes Vodobatinib as a breakthrough in the study of brain-related diseases, particularly in its role as a *c-Abl inhibitor* for protecting the nervous system. Dr. Ted Dawson from Johns Hopkins and global research groups have provided compelling evidence supporting the significance of c-Abl in this context. Vodobatinib, a super-specific inhibitor for c-Abl, has demonstrated remarkable efficacy in tiny amounts (Nano-molar), targeting both Abl 1 and Abl 2. Its ability to penetrate the brain effectively, with a safety profile conducive for clinical studies in neurodegenerative diseases, has been validated in preclinical and early clinical studies.
Speaking specifically about Vodobatinib's application in Parkinson's disease, the *PROSEEK study has surpassed expectations*, achieving its recruitment target of 513 evaluable patients in late October 2023. Notably, this marks one of the largest Phase 2b studies globally for early-stage Parkinson's disease. Anticipating interim analysis completion by March 2024, SPARC aims for an interim readout and phase 3 initiation after EOP2 indicated in November 2024.
PROSEEK, designed as a key study in the Parkinson's disease indication, is set to provide the initial solid confirmation for the c-Abl pathway. This large-scale global trial targets the right patient group, pre-treated with L-DOPA and confirmed with a PD diagnosis using DAT [dopamine transporter], over a 40-week period in part 1, followed by Part 2, another 40 weeks in the LTE (long-term extension) phase.
Beyond merely easing symptoms, PROSEEK signifies a potential breakthrough in extending the effectiveness of existing treatments for Parkinson's disease. Furthermore, by understanding early signs like constipation and REM sleep disorder, Vodobatinib and similar Abl inhibitors could play a crucial role as a consistent background treatment throughout various stages of Parkinson's disease therapy.
The ongoing Phase 2 trial, encompassing three arms - placebo, high dose, and low dose, is fully enrolled, with initial interim data expected in March 2024. Some PROSEEK study updates as indicated by *Dr. Siu-Long Yao* on the call indicates *no significant cardiac events* reported in the patients recruited and *GI and Rash* being the *most common AEs* reported.
Part 2 of the study involves a long-term extension, contributing to the overall study completion anticipated in May 2025. *Approximately 87% of eligible Part 1 patients have transitioned to Part 2*, possibly indicating a significant interest among those who have experienced positive outcomes in the trial. Eligibility of such subjects for Part 2 includes those patients who have voluntarily chosen to enrol in the extended program possibly indicating positive responses to the treatment.
The data enrolment that remain may be 50 in number, which we expect to be completed by November 2024. However, it is *unlikely that this new set will skew the data to unfavourablity and obstruct the path to registration of the drug*, therefore making the interim data stand as the final data.
Post the interim data read out, SPARC is gearing up to prioritize partnership strategies, secure regulatory agreements with global agencies, and initiate its first registrational program.
Parkinson's Disease, affecting approximately 7 million people worldwide, is on the rise, with an anticipated 14 million affected by 2040. SPARC's therapy has the potential to modify the disease trajectory, addressing all stages rather than merely treating symptoms.
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ANYONE IN THIS TRIAL: Prothena PASADENA Phase 2 trial? Love to hear what you think - some say most promising PD trial.
