Industry Press Releases

MedDay Pharmaceuticals Announces Completion of SPI2 Phase III Patient Trial for MD1003 in Progressive Multiple Sclerosis

Friday, Nov 09, 2018

MedDay Pharmaceuticals, a pioneering international biopharmaceutical company targeting brain metabolism for the treatment of central nervous system diseases, today announced the finalization of the recruitment of SPI2, a Phase III clinical trial of which The objective is to confirm the potential of MD1003, under development, in progressive multiple sclerosis (MS) already demonstrated in the Phase III MS-SPI trial. MedDay is continuing the clinical development of MD1003 with the goal of filing US ( New Drug Application , NDA) and European (AMM) marketing authorization applications in the second half of 2020.

Finalized Recruitment in Phase III SPI2 Trial Evaluating MD1003 in Progressive MS - MedDay Finalized Patient Recruitment in its Second Phase III Clinical Trial (SPI2), to Confirm and Strengthen Positive Outcomes of First Phase Trial Phase III (MS-SPI) has demonstrated the potential of MD1003, under development, to reverse disease progression in progressive multiple sclerosis (MS).

SPI2, a randomized, double-blind, placebo-controlled trial, is similar in construction to the previous Phase III trial (MS-SPI), and uses the same endpoint, which is to measure reversal of progression of the disease, on a larger patient population (n = 642) and for a prolonged treatment period equivalent to at least 15 months. The secondary endpoints are time to progression of the EDSS score, overall improvement clinical impression (CGI and SGI), and average change in the TW25 test score (test measuring walking time over a distance). 25 feet [7.62 m]). Exploratory evaluation criteria include measurements performed on cerebral MRI. Demographic data from the included population presented at the ECTRIMS conference in October 2018 confirmed that the trial focused on a population of patients with no but increasing progression. In the SPI2 trial, 90 clinical study centers are active worldwide (48 centers in the United States and Canada, 39 centers in Europe and 3 centers in Australia). The main data from the SPI2 trial are expected in the first quarter of 2020 and the submission of marketing authorization applications to regulatory agencies in the United States and Europe is expected in the second half of 2020. confirmed that the trial focused on a population of patients with no but increasing progression. In the SPI2 trial, 90 clinical study centers are active worldwide (48 centers in the United States and Canada, 39 centers in Europe and 3 centers in Australia). The main data from the SPI2 trial are expected in the first quarter of 2020 and the submission of marketing authorization applications to regulatory agencies in the United States and Europe is expected in the second half of 2020. confirmed that the trial focused on a population of patients with no but increasing progression. In the SPI2 trial, 90 clinical study centers are active worldwide (48 centers in the United States and Canada, 39 centers in Europe and 3 centers in Australia). The main data from the SPI2 trial are expected in the first quarter of 2020 and the submission of marketing authorization applications to regulatory agencies in the United States and Europe is expected in the second half of 2020.

A regulatory strategy focused on obtaining marketing authorization for MD1003, currently under development, in key markets - MedDay is in regular contact with the US Food and Drug Administration (FDA) and the United States. European Medicines Agency (EMA) regarding the development of MD1003 in the treatment of progressive MS. MedDay held a plenary end-of-phase meeting (EOP2) with the FDA in July 2018.

Christian Chavy, CEO of MedDay, comments: "The mechanism of action of our MD1003 experimental product has the potential to have a significant impact in the treatment of progressive multiple sclerosis. MedDay is fully committed to developing its clinical program with the aim of offering a therapeutic alternative to patients. "

About MD1003 MedDay's
lead product, the MD1003 is a patented formulation of high dose pharmaceutical grade biotin (hdPB) that is being developed in progressive multiple sclerosis (MS). MS-SPI is a Phase III clinical trial with MD1003 in patients with progressive MS who met the primary endpoint. MD1003 has a mechanism of action that can act on two targets associated with progressive MS: (1) it activates the Krebs cycle, the main energy production pathway that protects against axonal degeneration; and (2) activates acetyl-CoA carboxylases (ACC1 and ACC2), enzymes involved in the synthesis of fatty acids needed to repair myelin. MD1003 is an investigational product and has not been approved as a safe and effective drug by the FDA or EMA.

About MedDay
Founded in 2011, MedDay is a pioneering biopharmaceutical company that targets brain metabolism to treat diseases of the nervous system. The company's most advanced drug, MD1003, is a patented formulation of high-dose pharmaceutical biotin (hdPB) developed for progressive multiple sclerosis and other demyelinating diseases. MedDay is exploring brain metabolism on its metabolomics research platform, SPECMET, which enables it to identify new therapeutic targets. SPECMET analyzes cerebrospinal fluid (CSF) in patients with various central nervous system (CNS) disorders to identify disturbances in certain metabolic pathways. Molecules known to act on these metabolic pathways are then selected and developed. SPECMET was developed in collaboration with the French Atomic Energy Commission (CEA) and in March 2017, MedDay acquired the health division of Profilomic SA, an innovative company born from CEA in 2010, strengthening the research capabilities of MedDay at a time when the company wants to expand its pipeline. Among MedDay's shareholders are investors such as Sofinnova Partners, InnoBio, Andera Partners and Bpifrance Large Venture. MedDay is headquartered in Paris, with operations in Boston, USA. In March 2017, MedDay acquired the health division of Profilomic SA, an innovative company born of CEA in 2010, strengthening MedDay's research capabilities at a time when the company wants to expand its pipeline. Among MedDay's shareholders are investors such as Sofinnova Partners, InnoBio, Andera Partners and Bpifrance Large Venture. MedDay is headquartered in Paris, with operations in Boston, USA. In March 2017, MedDay acquired the health division of Profilomic SA, an innovative company born of CEA in 2010, strengthening MedDay's research capabilities at a time when the company wants to expand its pipeline. Among MedDay's shareholders are investors such as Sofinnova Partners, InnoBio, Andera Partners and Bpifrance Large Venture. MedDay is headquartered in Paris, with operations in Boston, USA. Andera Partners and Bpifrance Large Venture. MedDay is headquartered in Paris, with operations in Boston, USA. Andera Partners and Bpifrance Large Venture. MedDay is headquartered in Paris, with operations in Boston, USA.

For more information, please visit: www.medday-pharma.com

More information on the SPI2 trial is available at:
https://clinicaltrials.gov/ct2/show/NCT02936037?term=spi2&rank=1

contacts
MedDay Pharmaceuticals
Christian Chavy, Tel: +33 1 84 20 89 69
General Manager
Email: media@medday-pharma.com

 

Source: businesswire.com

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