[Translation] A Phase I, open-label clinical study to evaluate the pharmacokinetic characteristics, safety, and tolerability of a single dose of apomorphine hydrochloride injection (subcutaneous injection) in healthy Chinese subjects

主要目的：评估在中国健康受试者中单次给予盐酸阿扑吗啡注射液（皮下注射）1 mg、2 mg、3 mg 的药代动力学特征；次要目的：评估在中国健康受试者中单次给予盐酸阿扑吗啡注射液（皮下注射）1 mg、2 mg、3 mg 的安全性和耐受性。

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics of apomorphine hydrochloride injection (subcutaneous injection) of 1 mg, 2 mg, and 3 mg in healthy Chinese subjects; Secondary objective: To evaluate the safety and tolerability of apomorphine hydrochloride injection (subcutaneous injection) of 1 mg, 2 mg, and 3 mg in healthy Chinese subjects.

Start Date13 Jul 2023

Sponsor / Collaborator

Ignis Therapeutics (Suzhou) Limited

[+3]

NCT05043103 / Active, not recruitingNot Applicable

ELEGANCE - a Non-interventional Study on Long-term Effectiveness and Safety of Levodopa-Entacapone-Carbidopa Intestinal Gel (Lecigon®) in Patients with Advanced Parkinson's Disease in Routine Care

This observational study is designed to collect data on the use of the drug Lecigon® in daily clinical practice. The study is organised and funded by a pharmaceutical company called Britannia Pharmaceuticals Ltd (Britannia).
Lecigon® is prescribed by physicians in advanced Parkinson's disease when patients suffer from uncontrollable fluctuations in mobility, so-called motor fluctuations, which cannot be adjusted well with oral treatment, i.e. medication for swallowing.
In this study, data on the effect and possible side effects from everyday treatment with Lecigon® will be collected and scientifically evaluated. The study is intended to supplement the results of previous clinical studies with clinical data in routine medical care, collected from approximately 300 patients.

Start Date06 Jul 2021

Sponsor / Collaborator

Britannia Pharmaceuticals Ltd.

NCT02006121 / CompletedPhase 3

Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment

The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment.
The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.

Start Date03 Mar 2014

Sponsor / Collaborator

Britannia Pharmaceuticals Ltd.

100 Clinical Results associated with Britannia Pharmaceuticals Ltd.

0 Patents (Medical) associated with Britannia Pharmaceuticals Ltd.

Literatures (Medical) associated with Britannia Pharmaceuticals Ltd.

01 Nov 2023·Journal of Neural Transmission

Practical use of apomorphine infusion in Parkinson’s disease: lessons from the TOLEDO study and clinical experience

Article

Author: Lockhart, Donna ; Katzenschlager, Regina ; Staines, Harry ; Henriksen, Tove ; Bhidayasiri, Roongroj ; Lees, Andrew

AbstractSubcutaneous apomorphine infusion is a device-aided therapy for Parkinson’s disease that can be considered when motor fluctuations become persistent and are no longer adequately controlled by oral/transdermal medication. Apomorphine infusion is less invasive than enteral levodopa, deep brain stimulation or focused ultrasound, and is often indicated even when neurosurgical approaches are contraindicated. This article aims to provide practical guidance for doctors and nurses initiating and treating patients with apomorphine infusion, and is based on both trial data and clinical experience from movement disorders specialists. A post hoc analysis of data from the TOLEDO randomized clinical trial of apomorphine infusion was conducted along with an analysis of ‘real world’ experience from 13 movement disorders specialists using a questionnaire that focused on starting patients on apomorphine infusion. Practical guidelines for starting treatment with apomorphine infusion are provided taking into consideration the regional disparities in healthcare. Apomorphine infusion is straightforward to administer but to be successful it requires concordance from the patient and family, and clinical support from an experienced team of doctors and nurses, particularly in the early months of treatment.

01 Feb 2021·Parkinsonism & Related Disorders

Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study

Article

Author: Katzenschlager, Regina ; Poewe, Werner ; Trenkwalder, Claudia ; Lockhart, Donna ; Chaudhuri, K Ray ; van Laar, Teus ; Staines, Harry ; Henriksen, Tove ; Deuschl, Günther ; Rascol, Olivier ; Lees, Andrew

INTRODUCTIONThe randomized, double-blind phase (DBP) of the TOLEDO study confirmed the efficacy of apomorphine infusion (APO) in reducing OFF time in PD patients with persistent motor fluctuations despite optimized oral/transdermal therapy. Here we report safety and efficacy results including the 52-week open-label phase (OLP).METHODSAll patients completing the 12-week DBP (including those switching early to open-label treatment) were offered OLP entry. The primary objective was the evaluation of long-term safety of APO.RESULTSEighty-four patients entered the OLP (40 previously on APO, 44 on placebo) and 59 patients (70.2%) completed the study. The safety profile of APO was consistent with experience from extensive clinical use. Common treatment-related adverse events (AEs) were mild or moderate infusion site nodules, somnolence and nausea. Fourteen (16.7%) patients discontinued the OLP due to AEs, those involving >1 patient were infusion site reactions (n = 4) and fatigue (n = 2); hemolytic anemia occurred in one case. Reduction in daily OFF time and improvement in ON time without troublesome dyskinesia were sustained for up to 64 weeks. Pooled data for week 64 (n = 55) showed a mean (SD) change from DBP baseline in daily OFF time of -3.66 (2.72) hours and in ON time without troublesome dyskinesia of 3.31 (3.12) hours. Mean (±SD) daily levodopa-equivalent dose decreased from DBP baseline to week 64 by 543 mg (±674) and levodopa dose by 273 mg (±515).CONCLUSIONSThe safety and efficacy of APO infusion were demonstrated with long-term use for persistent motor fluctuations, allowing substantial reductions in oral PD medication.

02 Apr 2016·British Journal of Neuroscience Nursing

A case series of rapid titration of subcutaneous apomorphine in Parkinson's disease

Author: Turner, Marylin ; Arnold, Caroline ; Martin, Anne ; Ebenezer, Louise ; Price, Jane ; Parsons, Jan ; Duggan-Carter, Philippa

Subcutaneous apomorphine injections provide prompt relief of OFF periods, but are considered an underused therapy. One reason for this might be the perception of difficulty in initiating apomorphine therapy. Over the past 30 years of use, Parkinson’s nurses have built a wealth of experience in how to initiate apomorphine in patients with motor fluctuations. The authors present here a case series of 24 Parkinson’s patients whose apomorphine dose was rapidly titrated according to the practice of the Parkinson’s nurse overseeing the titration. Most patients were successfully and safely titrated within 2 hours, indicating that this rapid schedule may be useful in reducing patient distress and making better use of available resources, compared to the slower schedule than is suggested in the UK apomorphine prescribing information. Patients were successfully initiated in a wide variety of settings, including day hospitals and within their own homes.

News (Medical) associated with Britannia Pharmaceuticals Ltd.

09 Apr 2024

·www.prnewswire.com

Intrance Medical Systems Inc signs LOI purchase commitment for clinical trials with Parkinson's diseases patients

STOCKHOLM, April 9, 2024 /PRNewswire/ -- Tridentify are delighted to announce that Intrance Medical Systems Inc. now have signed a LOI purchase commitment of $ 300 000. Their Tridentify safeguarding solution will be used for the 'logistic journey' of the drug component for clinical trials in at least Europe and the US for patients with Parkinson diseases in advanced stage. The clinical development program for US registration has recently been initiated, with a larger more extensive study planned for late 2024. "Intrance Medical Systems is focused on the development and commercialization of its lead clinical product for the treatment of advanced Parkinson's disease. The product, Lecigon, is successfully marketed and available across Europe (by Britannia Pharmaceuticals). Intrance Medical plans to bring this innovative system to the US, Canada, Japan, Taiwan and LATAM. The US clinical development program includes key studies where accurate data to the FDA is paramount. Since Lecigon requires an unbroken cold supply chain and whose properties can change if improperly handled, we have found that Tridentify has a unique solution with monitoring and continuous calculation of remaining shelf life. We're excited about our collaboration and anticipate extending our partnership in the future," says Patrick Shea, CEO at Intrance Medical Systems Inc. " Tridentify is excited about the next steps with Intrance Medical Inc. Together with Intrance we want to ensure high quality standards in their important development of a new Parkinson treatment. We are proud to be able to safeguard the shipments for the clinical trials in Europe and in the US, as well as to support the important safety for patients with severe diseases," says Ann-Christine Jungmar, CEO at Tridentify. For further information, kindly contact: Ann-Christine Jungmar, CEO Tridentify +46 708 71 46 76 [email protected] This information was brought to you by Cision The following files are available for download:

Drug ApprovalClinical Study

04 Oct 2023

·www.prnewswire.com

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization. Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need. Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. STADA, which holds the commercial rights in the European Economic Area (EEA) member states, Switzerland and the UK, has already launched the IgAN medicine in Germany in September 2022 and is working to extend patient access to other countries. The submission to the MHRA for full approval, made by STADA's affiliate Britannia Pharmaceuticals Ltd., is based on the full two-year data set from the Phase 3 NefIgArd clinical trial, as recently published in leading medical journal The Lancet [1]. The trial met its primary endpoint, with Kinpeygo demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of nine months of treatment with Kinpeygo or placebo and 15 months of follow-up off drug. [1] Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial - The Lancet For further information, please contact: Åsa Hillsten, Head of Investor Relations & Sustainability, Calliditas Tel.: +46 76 403 35 43, email: asa.hillsten@calliditas.com The information was sent for publication, through the agency of the contact persons set out above, on October 3, 2023 at 09:20 a.m. CET. The following files are available for download: SOURCE Calliditas Therapeutics

Drug ApprovalClinical ResultPhase 3Orphan DrugNDA

100 Deals associated with Britannia Pharmaceuticals Ltd.

100 Translational Medicine associated with Britannia Pharmaceuticals Ltd.

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Drug(Targets)	Indications	Global Highest Phase

Apomorphine Hydrochloride ( DRDs )	Parkinson Disease More	Phase 1
Pumactant	Asthma More	Discontinued
Lofexidine Hydrochloride ( ADRA2 )	Substance Withdrawal Syndrome More	Pending

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