Randomized, Double Blind, Placebo Controlled, Incomplete Crossover Single Oral Dose Escalation of PRCL-02 in Normal Healthy Volunteers (Part A) and Multiple Oral Dose Escalation in Normal Healthy Volunteers (Part B) and in Chronic Plaque Psoriasis Patients (Part C)

This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)

Start Date20 Feb 2017

Sponsor / Collaborator

PRCL Research Inc.

100 Clinical Results associated with PRCL-02

100 Translational Medicine associated with PRCL-02

100 Patents (Medical) associated with PRCL-02

Literatures (Medical) associated with PRCL-02

01 May 2020·TransplantationQ2 · MEDICINE

Targeting Calcium Release–activated Calcium Channel Is Not Sufficient to Prevent Rejection in Nonhuman Primate Kidney Transplantation

Q2 · MEDICINE

Article

Author: Sloan-Lancaster, Joanne ; Song, Mingqing ; Yoon, Janghoon ; Rao, Patricia E ; Park, Jaeberm ; Ezekian, Brian ; Knechtle, Stuart J ; Manook, Miriam ; Fortier, Caroline ; Freischlag, Kyle ; Farris, Alton B ; Kwun, Jean

Background.Calcineurin inhibitors successfully control rejection of transplanted organs but also cause nephrotoxicity. This study, using a rhesus monkey renal transplantation model, sought to determine the applicability of a new immunomodulatory drug inhibiting the store-operated calcium release–activated calcium channel of lymphocytes to control transplant rejection without nephrotoxicity.Methods.Animals underwent kidney transplantation and were treated with tacrolimus alone (n = 3), a CRACM1 inhibitor (PRCL-02) (n = 6) alone, or with initial tacrolimus monotherapy followed by gradual conversion at 3 weeks to PRCL-02 alone (n = 3). PRCL-02 was administered via a surgically inserted gastrostomy tube BID.Results.Dose-related drug exposure in monkeys was established and renal transplants were then performed using PRCL-02 monotherapy. Oral dosing of PRCL-02 was well tolerated and resulted in suppressed T-cell proliferation in in vitro MLR comparable to animals in the tacrolimus control arm. Animals receiving tacrolimus monotherapy were e on day 100 without rejection. PRCL-02 monotherapy only marginally prolonged graft survival (MST = 13.16 d; group 2) compared with untreated controls. Animals treated initially with tacrolimus and converted to PRCL-02 monotherapy had a mean graft survival of 35.3 days which was prolonged compared with PRCL-02 monotherapy but not compared with the tacrolimus-treated group. Pharmacokinetic studies showed inconsistent drug exposures despite attempts to adjust dose and exposure which may have contributed to the rejections.Conclusions.We conclude that, in this nonhuman primate model of kidney transplantation, PRCL-02 demonstrated evidence of in vivo immunosuppressive activity but was inferior to tacrolimus treatment with respect to suppressing immune transplant rejection.

100 Deals associated with PRCL-02

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Indication	Highest Phase	Country/Location	Organization	Date
Psoriasis	Phase 2	-	Madrigal Pharmaceuticals, Inc.	-
Plaque psoriasis	IND Approval	CA	PRCL Research Inc.	25 Sep 2018
Plaque psoriasis	Discovery	SK	PRCL Research Inc.	25 Sep 2018
Plaque psoriasis	Discovery	UA	PRCL Research Inc.	25 Sep 2018
Psoriasis vulgaris	Discovery	CA	PRCL Research Inc.	25 Sep 2018
Psoriasis vulgaris	Discovery	SK	PRCL Research Inc.	25 Sep 2018
Psoriasis vulgaris	Discovery	UA	PRCL Research Inc.	25 Sep 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03614078 (CTgov)	Phase 2	Plaque psoriasis \| Psoriasis vulgaris	92	Placebo	ybguvhnbye(hunldeyeee) = wzvplidfaw ldvpzrvpeq (ultztogubr, wmsjmtwvej - csbhwprnot) View more	-	30 Mar 2020

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