Delving into the Latest Updates on RVT-1601 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Disodium cromoglicate

Target-

Action

stabilizers

Mechanism

Mast cells stabilizers

Therapeutic Areas

NeoplasmsImmune System DiseasesRespiratory Diseases+ [4]

Active Indication-

Inactive Indication

Chronic coughIdiopathic Pulmonary FibrosisIndolent systemic mastocytosis+ [5]

Originator Organization

Respivant Sciences, Inc.

Active Organization-

Inactive Organization

Respivant Sciences, Inc.

Patara Pharma LLC

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

Login to view timeline

Preterm birth predisposes infants to greater risk for respiratory morbidities and the need for pulmonary care compared to term infants both in the short-term and long-term. In the short-term, preterm birth is a high risk factor for development of bronchopulmonary dysplasia (BPD), the second most common chronic pediatric respiratory disease after asthma. In the long-term, following discharge from the neonatal intensive care unit (NICU) and the hospital, preterm birth carries a high risk for respiratory morbidities (e.g., wheezing, cough, doctor visits, and hospitalizations for respiratory infections) and resource use, which in turn predisposes infants to the development of lung diseases in childhood and adulthood, including airway hyperresponsiveness, asthma, and chronic obstructive pulmonary disease (COPD). There is a significant unmet need for safe and efficacious approaches in the prevention and treatment of respiratory morbidities of prematurity.
The study will be conducted in the neonatal intensive care unit (NICU) in preterm infants to determine safety, tolerability and lung delivery performance of RVT-1601, a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer/face mask.

Start Date01 Oct 2019

Sponsor / Collaborator

Respivant Sciences, Inc.

[+1]

EUCTR2018-004447-23-BE

/ Not yet recruitingPhase 2

Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial

Start Date02 May 2019

Sponsor / Collaborator

Respivant Sciences, Inc.

NCT03864328

/ TerminatedPhase 2

Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive life-threatening disease that is characterized by exertional dyspnea and persistent dry cough.
Cough in IPF is both a presenting and a complicating clinical feature, which affects approximately three quarters of IPF cases. It is often a debilitating symptom that adversely affects quality of life (QoL) and is usually refractory to medical therapy.
Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, is being evaluated in this Phase 2b study for the treatment of persistent cough in patients with IPF.

Start Date29 Mar 2019

Sponsor / Collaborator

Respivant Sciences, Inc.

[+1]

100 Clinical Results associated with RVT-1601

Login to view more data

100 Translational Medicine associated with RVT-1601

Login to view more data

100 Patents (Medical) associated with RVT-1601

Login to view more data

14

Literatures (Medical) associated with RVT-1601

01 May 2022·American Journal of Respiratory and Critical Care Medicine

Phase 2B Study of Inhaled RVT-1601 for Chronic Cough in Idiopathic Pulmonary Fibrosis: A Multicenter, Randomized, Placebo-controlled Study (SCENIC Trial)

Article

Author: Fogarty, Charles ; Chambers, Daniel C. ; Flaherty, Kevin R. ; Kolb, Martin ; Martinez, Fernando J. ; Maher, Toby M. ; Wijsenbeek, Marlies S. ; Kreuter, Michael ; Mogulkoc, Nesrin ; Raghu, Ganesh ; Wuyts, Wim A. ; Tutuncu, Ahmet S. ; Richeldi, Luca

Rationale: Chronic cough remains a major and often debilitating symptom for patients with idiopathic pulmonary fibrosis (IPF). In a phase 2A study, inhaled RVT-1601 (cromolyn sodium) reduced daytime cough and 24-hour average cough counts in patients with IPF. Objectives: To determine the efficacy, safety, and optimal dose of inhaled RVT-1601 for the treatment of chronic cough in patients with IPF. Methods: In this multicenter, randomized, placebo-controlled phase 2B study, patients with IPF and chronic cough for ⩾8 weeks were randomized (1:1:1:1) to receive 10, 40, and 80 mg RVT-1601 three times daily or placebo for 12 weeks. The primary endpoint was change from baseline to end of treatment in log-transformed 24-hour cough count. Key secondary endpoints were change from baseline in cough severity and cough-specific quality of life. Safety was monitored throughout the study. Measurements and Main Results: The study was prematurely terminated owing to the impact of the coronavirus disease (COVID-19) pandemic. Overall, 108 patients (mean age 71.0 years, 62.9% males) received RVT-1601 10 mg (n = 29), 40 mg (n = 25), 80 mg (n = 27), or matching placebo (n = 27); 61.1% (n = 66) completed double-blind treatment. No statistically significant difference was observed in the least-square mean change from baseline in log-transformed 24-hour average cough count, cough severity, and cough-specific quality of life score between the RVT-1601 groups and the placebo group. The mean percentage change from baseline in 24-hour average cough count was 27.7% in the placebo group. Treatment was generally well tolerated. Conclusions: Treatment with inhaled RVT-1601 (10, 40, and 80 mg three times a day) did not provide benefit over placebo for the treatment of chronic cough in patients with IPF.

01 May 2020·Journal of Photochemistry and Photobiology B: BiologyQ2 · BIOLOGY

In vitro study of disodium cromoglicate as a novel effective hydrotrope solvent for hypericin utilisation in photodynamic therapy

Q2 · BIOLOGY

Article

Author: Rastislav Jendželovský ; Andrej Hovan ; Marián Antalík ; Gregor Bánó ; Peter Fedoročko ; Martin Majerník ; Mária Suváková

Hypericin (HY) is a naphthodianthrone that naturally occurs in Hypericum perforatum L. It is a promising photosensitiser used in photodynamic therapy for and diagnosis of oncological diseases. However, its hydrophobic character is an obstacle that has prevented its efficient use. The commonly used solvent, dimethyl sulfoxide (DMSO), is a controversial constituent of HY formulations and its use has been rejected by many researchers studying HY both in vitro and in vivo. In this study, we propose the utilisation of hydrotropy to solubilise HY in an aqueous environment. Cromolyn (DSCG) is a non-toxic, well-tolerated, antiallergic drug that has been employed in clinical practice since 1970, and in aqueous solution it acts as a hydrotrope. At a molecular ratio of 1:12,000 HY to DSCG, the compound is able to solubilise HY in aqueous environment. In an HT-29 cell suspension, DSCG (1.8 mmol L^-1) considerably enhances the interaction between HY (150 nmol L^-1) and HT-29 cells, which leads to an HY fluorescence emission increase with a half-time approximately 2 min compared to 29 min for samples that lack DSCG. Studies using HT-29 adenocarcinoma cells showed that DSCG at a given concentration significantly improved accumulation of HY within cells compared to DMSO (p < 0.05) despite the relative resistance of the HT-29 cell line to HY-PDT. Though no significant difference between total reactive oxygen species production was observed for photoactivated HY dissolved in DMSO and DSCG, significant singlet oxygen generation by photoactivated HY dissolved in a DSCG-containing water solution at the studied molecular ratio was confirmed. We also clarified that DSCG does not act as a scavenger of ABTS and galvinoxyl free radicals. The results from an MTT assay showed that DSCG also significantly enhanced the cytotoxicity of photoactivated HY compared to DMSO (p < 0.05). This study has demonstrated the ability of DSCG to act as a solvent of HY and enhance the effectiveness of HY-PDT compared to the commonly used organic solvent, DMSO.

01 Jan 2020·European Clinical Respiratory Journal

Improved bioavailability of cromolyn sodium using inhaled PA101 delivered via eFlow® nebulizer

Article

Author: Diamant, Zuzana ; Abd-Elaziz, Khalid ; Oude Elberink, Hanneke

In 1960s, cromolyn sodium (CS) has been introduced as the first non-steroidal anti-inflammatory drug for the treatment of allergic and mast-cell driven diseases. Its applicability has been limited due to a poor bioavailability. Here we present pharmacokinetic data of a novel high concentration formulation of CS (PA101) delivered via a high-efficiency nebulizer (eFlow®) in healthy volunteers (HVs), allergic asthmatics and patients with indolent systemic mastocytosis (ISM). In HVs, PA101 40 mg and 80 mg (30 L) and PA101 40 mg (40 L), Intal^TM (via LC® Plus) 20 mg and Nalcrom® (oral suspension) 200 mg showed maximum measured plasma concentration (C_max) of 156, 236, 88.6, 17.8 and 5.23 ng/mL, respectively, with respective areas under the plasma time-concentration curve (AUC) of 338, 526, 212, 40.6 and 33.3 h·ng/mL. Systemic exposure (AUC) to CS with PA101 40 mg was approximately 8-fold and 11-fold higher compared to Intal^TM and Nalcrom® in HVs, respectively. PA101 via eFlow® yielded comparable PK profiles in HVs and patients. Systemic bioavailability of PA101 was approximately 25% compared to approximately 1% for Nalcrom® and approximately 10% for Intal^TM, respectively. These data warrant further research on the therapeutic potential of PA101 (via eFlow®) in allergic and mast-cell driven diseases.

100 Deals associated with RVT-1601

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 2	Canada	Respivant Sciences, Inc.	29 Mar 2019
Kidney Failure, Chronic	Phase 2	United States	Patara Pharma LLC	01 Feb 2016
Uremic pruritus	Phase 2	United States	Patara Pharma LLC	01 Feb 2016
Indolent systemic mastocytosis	Phase 2	Germany	Patara Pharma LLC	01 Jun 2015
Indolent systemic mastocytosis	Phase 2	Spain	Patara Pharma LLC	01 Jun 2015
Indolent systemic mastocytosis	Phase 2	Italy	Patara Pharma LLC	01 Jun 2015
Indolent systemic mastocytosis	Phase 2	Netherlands	Patara Pharma LLC	01 Jun 2015
Indolent systemic mastocytosis	Phase 2	France	Patara Pharma LLC	01 Jun 2015
Refractory chronic cough	Phase 2	United Kingdom	Patara Pharma LLC	01 Feb 2015
Refractory chronic cough	Phase 2	Netherlands	Patara Pharma LLC	01 Feb 2015

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03864328 (SCENIC, Pubmed) Manual	Phase 2	Idiopathic Pulmonary Fibrosis \| Chronic cough	108	RVT-1601	ripciqsdvr(yeuntybptb) = afcwhamyob gxkgaultsp (vseutnumih )	Negative	20 Jan 2022
				Placebo	ripciqsdvr(yeuntybptb) = yfvlgfysxe gxkgaultsp (vseutnumih )