Double Blind Randomised Placebo and Active Controlled, Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge to Allergic Patients Otherwise Healthy

The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.

Start Date01 Dec 2010

Sponsor / Collaborator

Palau Pharma SA

NCT00808977 / CompletedPhase 2

A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis

The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.

Start Date01 Dec 2008

Sponsor / Collaborator

Palau Pharma SA

EUCTR2007-005672-13-FR / Unknown statusNot Applicable

DOUBLE-BLIND STUDY, RANDOMISED, ACTIVE AND PLACEBO CONTROLLED TO ASSESS THE CLINICAL EFFICACY, SKIN TOLERABILITY AND PHARMACOLOGICAL ACTIVITY OF UR-1505 OINTMENT AT THREE DIFFERENT STRENGHTS IN PATIENTS WITH MILD TO MODERATE PLAQUE-TYPE PSORIASIS

Start Date28 Dec 2007

Sponsor / Collaborator

Palau Pharma SA

100 Clinical Results associated with Palau Pharma SA

0 Patents (Medical) associated with Palau Pharma SA

Literatures (Medical) associated with Palau Pharma SA

01 Jan 2013·Frontiers in Bioscience

Is the H4 receptor a new drug target for allergies and asthma

Review

Author: Pontes, Caridad ; Merlos, Manuel ; Salcedo, Carolina

Histamine H4 receptor (H4R) has become a promising target for immuno-inflammatory diseases, such as allergic rhinitis, asthma or dermal allergies. Its distribution pattern in immune cells and the preclinical data obtained from different biological systems using diverse histamine H4 modulators (1) suggest a key role of H4R in immunity and in inflammatory cell trafficking. Recent results with UR-63325, the first H4R antagonist from which clinical data has been reported (2), confirm the feasibility of complete H4R blocking in humans without limiting safety concerns. Also, H4R blockade results in clear pharmacodynamic effects in relevant human cells, e.g. eosinophils. It is believed that allergic rhinitis and asthma are manifestations of one unique syndrome in two parts of the respiratory tract. Dermal allergies are also recognized as related manifestations in a different location. The coexistence of allergic-related diseases in the same patients could permit a single treatment approach e.g.. the systemic use of H4R antagonists. Further clinical studies are needed to establish the role of H4R antagonists in the treatment of allergic diseases.

01 Mar 2010·Inflammation Research

UR-60427, a novel H4 receptor-inverse agonist that shows good efficacy in a rat asthma model

Article

Author: E. Morcillo ; B. Gil-Torregrosa ; J. Cortijo ; X. Bartrolí ; A. Fernández ; M. Merlos ; N. Ardanaz ; J. Alfón ; E. Carceller ; Ll. Gómez ; D. Balsa

01 Aug 2007·Molecular PharmacologyQ3 · MEDICINE

UR-1505, a New Salicylate, Blocks T Cell Activation through Nuclear Factor of Activated T Cells

Q3 · MEDICINE

Article

Author: Galvez, Julio ; Michelena, Pedro ; Ramis, Isabel ; Merlos, Manuel ; Zarzuelo, Antonio ; Comalada, Monica ; Barron, Sonia ; Roman, Juan ; Fernandez de Arriba, Alberto ; Bailon, Elvira ; Giral, Marta

2-Hydroxy-4(-2,2,3,3,3-pentafluoropropoxy)-benzoic acid (UR-1505), a new molecule chemically related to salicylic acid, has immunomodulator properties and is currently under clinical development for treatment of atopic dermatitis. The present work describes the immunomodulatory profile of UR-1505. UR-1505 targets T cells, inhibiting their proliferation and cytokine production by blocking nuclear factor of activated T cells (NF-AT) DNA-binding activity. The effects of UR-1505 (100-300 microM) on T cell proliferation seems to be dependent on the stimulus, because UR-1505 inhibited CD3/CD28-induced T-cell proliferation, increased p27(KIP) levels, and induced G1/S cell arrest but, interestingly, did not inhibit the Janus tyrosine kinase/signal transducer and activator of transcription-induced T-cell proliferation. These data suggest that UR-1505 acts by means of a specific mechanism inhibiting T cell activation depending on T cell receptor signaling pathway. Furthermore, the antiproliferative effects of UR-1505 are not a consequence of decreased cell viability. In addition to the inhibition of T-cell proliferation, UR-1505 decreased, in a dose-dependent manner, the production of interleukin (IL)-5 and interferon (IFN)-gamma in activated T cells, and this effect was produced at the transcriptional level. Because T-cell proliferation and cytokine production were regulated through NF-AT, we examined the effect of UR-1505 on this transcription factor. According to its effect on IL-5 and IFN-gamma mRNA expression, UR-1505 specifically inhibited NF-AT DNA binding without effect on nuclear factor-kappaB and activator protein-1 activities. The effect of UR-1505 on NF-AT is not attributable to a blockade of nuclear import. In conclusion, UR-1505 is a new immunomodulator agent that specifically inhibits NF-AT activation. Because NF-AT regulates the transcription of most genes involved in lymphocyte activation, its selective inactivation results in both decreased T-cell proliferation and cytokine production.

News (Medical) associated with Palau Pharma SA

27 Feb 2023

·www.globenewswire.com

Changes in the governance of NFL Biosciences

Changes in the governance of NFL Biosciences NFL BIOSCIENCES (Euronext Growth Paris - FR0014003XT0 - ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of addictions, and in particular NFL-101, its drug candidate for smoking cessation, announces the appointment of Ignacio Faus, current CEO, as Chairman of the Board of Directors. Appointment of Dr. Ignacio Faus as Chairman of the Board of Directors At its meeting on February 27, 2023, the Board of Directors of NFL Biosciences acknowledged the wish of Mr. Joël Besse to step down as Chairman and member of the Board of Directors in order to fully devote himself to his activity as investor in unlisted startup companies in the life sciences sector. Dr. Ignacio Faus, currently Director and Chief Executive Officer of NFL Biosciences, has been appointed Chairman of the Board of Directors and now becomes Chairman and Chief Executive Officer, replacing Mr. Joël Besse. Having joined NFL Biosciences in 2019 as an investor, Dr. Ignacio Faus joined the management team in early 2021. He has 27 years of experience in large and medium-sized pharmaceutical companies and in private and public biotech companies: Bristol Myers Squibb, Grupo Uriach, Ferrer and co-founder in 2006 and CEO of Palau Pharma (divested in 2013). In recent years, Ignacio Faus has also been a Director of several private and public biotech companies as well as private equity funds in Europe and the United States. He holds a PhD in Biochemistry (Indiana University, USA) and an MBA in Entrepreneurship and Finance from the Kellogg School of Management (Northwestern University, USA). Ignacio Faus, Chairman and CEO of NFL Biosciences, commented: “I am very honored to take over as Chairman of the Board of NFL Biosciences and would like to sincerely thank Joël Besse for his operational and financial involvement since 2018. After his support during the IPO, the company now has a secure financial position for the next 18 months, following the recently concluded capital increase and the financing from Bpifrance.” About NFL Biosciences NFL Biosciences is a biopharmaceutical company based in the Montpellier area which develops botanical drug candidates for the treatment of addictions. NFL Biosciences' ambition is to bring new, natural, safer and more effective therapeutic solutions to the entire world population, including low- and middle-income countries. Its most advanced product, called NFL-101, is a standardized, nicotine free tobacco leaf extract protected by two patent families. NFL Biosciences intends to offer smokers who want to quit a natural, safe, easy-to-administer and personalized alternative. NFL Biosciences is also developing NFL-301, a natural drug candidate for the reduction of alcohol consumption and has a drug development project for the treatment of cannabis use disorders. The shares of NFL Biosciences are listed on Euronext Growth Paris (FR0014003XT0 – ALNFL). Find out more at www.nflbiosciences.com Contacts Bruno Lafont – info@nflbiosciences.com - +33 4 11 93 76 67 Agence Calyptus – nflbio@calyptus.net - +33 1 53 65 68 68 Attachment NFLBiosciences_CP_Gouvernance_ENG

Executive Change

100 Deals associated with Palau Pharma SA

100 Translational Medicine associated with Palau Pharma SA

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Seliforant ( H4 receptor )	Vertigo More	Phase 2
UR-13870 ( p38α )	Rheumatoid Arthritis More	Preclinical
Albaconazole ( fungal CYP51A1 )	Mycoses More	Discontinued
UR-1505 ( Cytokines x NFATC1 )	Inflammatory Bowel Diseases More	Discontinued
UR-60427 ( H4 receptor )	Asthma More	Pending

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