A Randomised, Double-blind, Placebo Controlled Study to Determine the Safety, Pharmacokinetics and Efficacy of Topical ZPL-5212372 Ointment Administered BID for up to 2 Weeks in Healthy Subjects and Subjects With Atopic Dermatitis.

A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis

Start Date01 Jun 2016

Sponsor / Collaborator

Ziarco Pharma Ltd.

EUCTR2016-000376-26-GB / Not yet recruitingPhase 1/2

A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential Group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis

Start Date09 May 2016

Sponsor / Collaborator

Ziarco Pharma Ltd.

EUCTR2015-003812-19-BG / Not yet recruitingPhase 2

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF ONCE DAILY ORAL ZPL-3893787-18 (30 MG) ADMINISTERED FOR 12 WEEKS IN ADULT SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS.

Start Date24 Feb 2016

Sponsor / Collaborator

Ziarco Pharma Ltd.

100 Clinical Results associated with Ziarco Pharma Ltd.

0 Patents (Medical) associated with Ziarco Pharma Ltd.

Literatures (Medical) associated with Ziarco Pharma Ltd.

01 May 2019·Journal of Allergy and Clinical ImmunologyQ1 · MEDICINE

Efficacy and safety of the histamine H4 receptor antagonist ZPL-3893787 in patients with atopic dermatitis

Q1 · MEDICINE

Article

Author: Purkins, Lynn ; Lynch, Victoria ; Werfel, Thomas ; Asher, Aliya ; Layton, Gary ; Whitlock, Lyndsey ; Tsianakas, Athanasios ; Jimenez, Pablo ; Yeadon, Michael ; Osterloh, Ian ; Liu, Wai

BACKGROUNDH₄ receptor antagonists are potential novel treatments for inflammatory skin diseases, including atopic dermatitis (AD).OBJECTIVEWe sought to study the efficacy and safety of ZPL-3893787 (a selective H₄ receptor antagonist) in patients with moderate-to-severe AD.METHODSA randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate ZPL-3893787 (30 mg) once-daily oral therapy in adults with moderate-to-severe AD. Patients were randomized (2:1) to ZPL-3893787 (n = 65) or placebo (n = 33) for 8 weeks. Patients had a history of AD for more than 12 months, Eczema Area and Severity Index (EASI) scores of 12 or greater and 48 or less, Investigator's Global Assessment (IGA) scores of 3 or greater, pruritus scores of 5 or greater (0- to 10-point scale), and AD on 10% or greater of body surface area. Efficacy parameters included EASI, IGA, SCORAD, and pruritus assessment.RESULTSTreatment with oral ZPL-3893787 showed a 50% reduction in EASI score compared with 27% for placebo. The placebo-adjusted reduction in EASI score at week 8 was 5.1 (1-sided P = .01). Clear or almost-clear IGA scores were 18.5% with ZPL-3893787 versus 9.1% with placebo. SCORAD scores exhibited 41% reduction with ZPL-3893787 versus 26% with placebo (placebo-adjusted reduction of 10.0, P = .004). There was a 3-point reduction (scale, 1-10) in pruritus with ZPL-3893787, but there was a similar reduction with placebo, resulting in a nonsignificant difference (P = .249). Patient-reported pruritus subscores obtained from SCORAD were reduced with ZPL-3893787 compared with placebo at week 8 (nonsignificant). ZPL-3893787 was well tolerated.CONCLUSIONFor the first time, these results showed that ZPL-3893787 improved inflammatory skin lesions in patients with AD, confirming H₄ receptor antagonism as a novel therapeutic option.

01 Dec 2017·TrialsQ4 · MEDICINE

Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Q4 · MEDICINE

ArticleOA

Author: Roblin, David ; Ashworth, Alan ; Burn, John ; Langtry, James ; Cranston, Amy ; Stocken, Deborah D ; Plummer, Ruth ; Rajan, Neil ; Stamp, Elaine ; Hamlin, Julia

BACKGROUNDPatients with germline mutations in a tumour suppressor gene called CYLD develop multiple, disfiguring, hair follicle tumours on the head and neck. The prognosis is poor, with up to one in four mutation carriers requiring complete surgical removal of the scalp. There are no effective medical alternatives to treat this condition. Whole genome molecular profiling experiments led to the discovery of an attractive molecular target in these skin tumour cells, named tropomyosin receptor kinase (TRK), upon which these cells demonstrate an oncogenic dependency in preclinical studies. Recently, the development of an ointment containing a TRK inhibitor (pegcantratinib - previously CT327 - from Creabilis SA) allowed for the assessment of TRK inhibition in tumours from patients with inherited CYLD mutations.METHODS/DESIGNTropomysin Receptor Antagonism in Cylindromatosis (TRAC) is a two-part, exploratory, early phase, single-centre trial. Cohort 1 is a phase 1b open-labelled trial, and cohort 2 is a phase 2a randomised double-blinded exploratory placebo-controlled trial. Cohort 1 will determine the safety and acceptability of applying pegcantratinib for 4 weeks to a single tumour on a CYLD mutation carrier that is scheduled for a routine lesion excision (n = 8 patients). Cohort 2 will investigate if CYLD defective tumours respond following 12 weeks of treatment with pegcantratinib. As patients have multiple tumours, we intend to treat 10 tumours in each patient, 5 with active treatment and 5 with placebo. Patients will be allocated both active and placebo treatments to be applied randomly to tumours on the left or right side. The target is to treat 150 tumours in a maximum of 20 patients. Tumour volume will be measured at baseline and at 4 and 12 weeks. The primary outcome measure is the proportion of tumours responding to treatment by 12 weeks, based on change in tumour volume, with secondary measures based on adverse event profile, treatment compliance and acceptability, changes in tumour volume and surface area, patient quality of life and pain.DISCUSSIONInterventions for rare genetic skin diseases are often difficult to assess in an unbiased way due to small patient numbers and the challenges of incorporating adequate controls into trial design. Here we present a single-centre, randomised, placebo-controlled trial design that leverages the multiplicity of tumours seen in an inherited skin tumour syndrome that may inform the design of other studies in similar genetic diseases.TRIAL REGISTRATIONInternational Standard Randomised Controlled Trial Number Registry, ISRCTN75715723 . Registered on 22 October 2014.

01 Aug 2014·Drug Discovery TodayQ2 · MEDICINE

Histamine H4 receptor antagonists for the treatment of inflammatory disorders

Q2 · MEDICINE

Review

Author: Liu, Wai L

Since its initial discovery by Sir Henry Dale and Patrick Laidlaw in 1910, the biogenic amine histamine has been one of the most widely researched molecules in science. H4R, the newest member of the histamine receptor family, was first identified at the turn of the millennium. Its predominant expression on inflammatory cells and lymphoid tissues, coupled with a key role in processes ranging from chemotaxis to cytokine release, suggests it could command an important role in immune and inflammatory responses.

100 Deals associated with Ziarco Pharma Ltd.

100 Translational Medicine associated with Ziarco Pharma Ltd.

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

ZPL-5212372 ( PLA2 )	Dermatitis, Atopic More	Phase 2
ZPL-389 ( H4 receptor )	Plaque psoriasis More	Pending
ZPL-868087 ( H3 receptor )	Rhinitis, Allergic More	Pending

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