Delving into the Latest Updates on XEN-D0501 with Synapse

This is a randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.

Start Date25 Feb 2019

Sponsor / Collaborator

Pila Pharma AB

[+1]

EUCTR2018-001880-22-LT

/ Not yet recruitingPhase 2

A randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes type 2

Start Date23 Aug 2018

Sponsor / Collaborator

Pila Pharma AB

NCT03278158

/ CompletedPhase 2

A Single-dose Dose Escalation Trial in a Randomised, Single-blind, Placebo-controlled Group-comparison Design to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2

This is a single-dose dose escalation trial in a randomised, single-blind, placebo-controlled group-comparison design to investigate the safety and tolerability of XEN-D0501 in subjects with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.

Start Date18 Sep 2017

Sponsor / Collaborator

Pila Pharma AB

100 Clinical Results associated with XEN-D0501

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100 Translational Medicine associated with XEN-D0501

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100 Patents (Medical) associated with XEN-D0501

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Literatures (Medical) associated with XEN-D0501

15 Nov 2017·American Journal of Respiratory and Critical Care Medicine

XEN-D0501, a Novel Transient Receptor Potential Vanilloid 1 Antagonist, Does Not Reduce Cough in Patients with Refractory Cough

Article

Author: McGarvey, Lorcan ; Badri, Huda ; Holt, Kimberley ; Birrell, Mark A. ; Smith, Jaclyn A. ; Maher, Sarah A. ; Wortley, Michael A. ; Satia, Imran ; Belvisi, Maria G. ; Round, Patrick ; Ford, John

RATIONALEHeightened cough responses to inhaled capsaicin, a transient receptor potential vanilloid 1 (TRPV1) agonist, are characteristic of patients with chronic cough. However, previously, a TRPV1 antagonist (SB-705498) failed to improve spontaneous cough frequency in these patients, despite small reductions in capsaicin-evoked cough.OBJECTIVESXEN-D0501 (a potent TRPV1 antagonist) was compared with SB-705498 in preclinical studies to establish whether an improved efficacy profile would support a further clinical trial of XEN-D0501 in refractory chronic cough.METHODSXEN-D0501 and SB-705498 were profiled against capsaicin in a sensory nerve activation assay and in vivo potency established against capsaicin-induced cough in the guinea pig. Twenty patients with refractory chronic cough participated in a double-blind, randomized, placebo-controlled crossover study evaluating the effect of 14 days of XEN-D0501 (oral, 4 mg twice daily) versus placebo on awake cough frequency (primary outcome), capsaicin-evoked cough, and patient-reported outcomes.MEASUREMENTS AND MAIN RESULTSXEN-D0501 was more efficacious and 1,000-fold more potent than SB-705498 at inhibiting capsaicin-induced depolarization of guinea pig and human isolated vagus nerve. In vivo XEN-D0501 completely inhibited capsaicin-induced cough, whereas 100 times more SB-705498 was required to achieve the same effect. In patients, XEN-D0501 substantially reduced maximal cough responses to capsaicin (mean change from baseline, XEN-D0501, -19.3 ± 16.4) coughs; placebo, -1.8 ± 5.8 coughs; P < 0.0001), but not spontaneous awake cough frequency (mean change from baseline, XEN-D0501, 6.7 ± 16.9 coughs/h; placebo, 0.4 ± 13.7 coughs/h; P = 0.41).CONCLUSIONSXEN-D0501 demonstrated superior efficacy and potency in preclinical and clinical capsaicin challenge studies; despite this improved pharmacodynamic profile, spontaneous cough frequency did not improve, ruling out TRPV1 as an effective therapeutic target for refractory cough. Clinical trial registered with www.clinicaltrialsregister.eu (2014-000306-36).

100 Deals associated with XEN-D0501

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Urinary Bladder, Overactive	Phase 2	-	Xention Ltd.	07 Jan 2011
Diabetes Mellitus, Type 2	Phase 2	-	Pila Pharma AB	-
Aortic Aneurysm, Abdominal	Preclinical	SE	Pila Pharma AB	13 Nov 2024
Erythromelalgia	Preclinical	US	Pila Pharma AB	21 Nov 2023
Chronic cough	Discovery	GB	ario pharma Ltd.	01 Jul 2014
Chronic cough	Discovery	IE	Xention Ltd.	01 Jul 2014
Chronic cough	Discovery	IE	ario pharma Ltd.	01 Jul 2014
Chronic cough	Discovery	GB	Xention Ltd.	01 Jul 2014
Pulmonary Disease, Chronic Obstructive	Discovery	GB	ario pharma Ltd.	01 Feb 2014
Pulmonary Disease, Chronic Obstructive	Discovery	GB	Xention Ltd.	01 Feb 2014