Delving into the Latest Updates on SUN-K706 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Vodobatinib

+ [4]

Target

Bcr-Abl

Mechanism

Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors)

Therapeutic Areas

NeoplasmsNervous System DiseasesEndocrinology and Metabolic Disease+ [2]

Active Indication

Philadelphia chromosome positive chronic myelogenous leukemiaLewy Body DiseaseChronic phase chronic myeloid leukemia+ [2]

Inactive Indication

Young onset Parkinson disease

Originator Organization

Sun Pharma Advanced Research Co. Ltd.

Active Organization

Sun Pharma Advanced Research Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (EU)

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Structure

Molecular FormulaC27H20ClN3O2

InChIKeyZQOBVMHBVWNVBG-UHFFFAOYSA-N

CAS Registry1388803-90-4

This study evaluates the safety and tolerability of treatment with K0706 in Dementia with Lewy Bodies (DLB).
The hypothesis is that K0706 will be safe and tolerable and that this drug will alter CSF and plasma biomarkers in DLB. Clinical assessments of cognitive, behavioral and motor functioning will also be evaluated. A total of 45 participants will be randomized 1:1:1 into 3 groups (n=15/per group) to be treated with sachet of 192 mg powder of K0706 ( equivalent to 96 mg capsule of K0706) or sachet of 384 mg powder of K0706 (equivalent to 192 capsule of K0706) or sachet of matching placebo ( equivalent to a capsule of placebo) for 12 weeks, followed by 4-week wash-out period.

Start Date05 Sep 2019

Sponsor / Collaborator

Georgetown University

[+1]

NCT03655236 / TerminatedPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease

This study consists of 2 parts. Part 1 of the study is conducted to evaluate the efficacy, safety, and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving dopaminergic therapy. Part 2 is an optional long term extension study for subjects who have completed week 40 of Part 1

Start Date18 Feb 2019

Sponsor / Collaborator

Sun Pharma Advanced Research Co. Ltd.

100 Clinical Results associated with SUN-K706

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100 Translational Medicine associated with SUN-K706

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100 Patents (Medical) associated with SUN-K706

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6

Literatures (Medical) associated with SUN-K706

01 Jun 2023·Clinical lymphoma, myeloma & leukemia

Management of Chronic Myeloid Leukemia Patients in Later Lines: The Role of Ponatinib and New Compounds.

Review

Author: Martelli, Maurizio ; Costa, Alessandro ; Scalzulli, Emilia ; Carmosino, Ida ; Breccia, Massimo ; Bisegna, Maria Laura

Limited therapeutic options and poor response probability still represent some unresolved issue in later lines chronic myeloid leukemia (CML) patients. In addition, sequential treatment is associated with reduced overall survival and may select new mutation, including the T315I, further reducing the therapeutic chances: outside the United States, ponatinib and allogenic stem cell transplant are the only available options. In the last decade, ponatinib improved outcomes in third-line patients, although limited by the risk of severe adverse occlusive events. Dose optimization strategies with lower doses of ponatinib in selected patients have shown to reduce toxicity while retaining efficacy, but higher doses are needed in T315I patients for an adequate disease control. Recently approved by FDA, the first-of-its-kind STAMP inhibitor asciminib has proven safe and effective, obtaining deep and stable molecular responses even in heavily pretreated patients and with T315I mutation. Unfortunately, a significant proportion of patients remain intolerant or refractory, making it crucial to develop new therapeutic options. Among these, novel agents such as vodobatinib and olverembatinib have provided promising result in clinical trials, representing valuable therapeutic possibilities in intolerant or refractory patients. Therefore, a more complex therapeutic paradigm is expected in the near future.

01 Mar 2023·Parkinsonism & Related Disorders

A novel brain penetrant c-Abl tyrosine kinase inhibitor: Paving a path forward to success in disease modification in Parkinson's disease

Author: Simuni, Tanya ; Merchant, Kalpana

A review.A review discussing novel brain penetrant c-abl tyrosine kinase inhibitor, paving a path forward to success in disease modification in Parkinson's disease.It also discusses vodobatinib appears to have better potency and greater central penetration than nilotinib.

01 Mar 2023·Parkinsonism & Related Disorders

Plasma and cerebrospinal fluid pharmacokinetics of vodobatinib, a neuroprotective c-Abl tyrosine kinase inhibitor for the treatment of Parkinson's disease

Article

Author: Love, Damon ; Damle, Nitin K ; Mandhane, Sanjay ; Piccoli, Steven P ; Ramanathan, Vikram ; Hurko, Orest ; Talluri, Ravi S ; Yao, Siu-Long ; Walsh, Ryan R

BACKGROUNDPreclinical evidence suggests that c-Abl is critical in the pathogenesis of Parkinson's Disease (PD). Vodobatinib (K0706) is a potent, specific Abl kinase inhibitor currently being developed for the treatment of PD. In previously reported studies, nilotinib, a multikinase c-Abl inhibitor, did not show clinical activity as evidenced by no improvement of symptoms or the rate of decline after one to six months of treatment at the maximum permissible dose, presumably because of insufficient CNS penetration. Here we report clinical PK and safety data for vodobatinib.OBJECTIVESTo determine safety, plasma PK, and CSF penetration of vodobatinib in healthy volunteers and PD subjects following oral administration, and compare CSF levels to in vitro concentrations required for c-Abl inhibition relative to data reported for nilotinib.METHODSInhibition of c-Abl kinase activity and c-Abl binding affinity were first assessed in vitro. Healthy human volunteers and PD patients received various oral doses of vodobatinib once-daily for seven and fourteen days respectively, to assess safety, and plasma and CSF PK.RESULTSIn in vitro assays, vodobatinib was more potent (kinase IC₅₀ = 0.9 nM) than nilotinib (kinase IC₅₀ = 15-45 nM). Administration of vodobatinib 48, 192 and 384 mg to healthy subjects for 7 days yielded mean C_{max, CSF} values of 1.8, 11.6, and 12.2 nM respectively, with the two highest doses exceeding the IC₅₀ over the entire dosing interval. C_{avg, CSF} values were 6-8 times greater than the IC₅₀. Comparable CSF levels were observed in PD patients. All doses were well tolerated in both cohorts.CONCLUSIONBased 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.

100 Deals associated with SUN-K706

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Philadelphia positive acute lymphocytic leukaemia	Phase 2	ES	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	IN	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	GB	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	KR	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	HU	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	FR	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	TR	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	IT	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	BE	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	RO	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02629692 (ASH2021) Manual	Phase 1	Philadelphia positive acute lymphocytic leukaemia \| Philadelphia chromosome positive chronic myelogenous leukemia Last line Philadelphia Chromosome Positive	52	vodobatinib (dose-escalation (DEs))	(oghtqzfzgs) = Nineteen pts (37%) reported SAEs; vodobatinib related SAEs were reported in 3 pts (fatal intracranial haemorrhage (ICH), Grade 2 back pain and Grade 3 amnesia reported in 1 pt each) lghniazkdt (mbbprjnadh ) View more	Positive	05 Nov 2021
				vodobatinib 174 mg (dose-expansion (DEx))