We are pleased to announce that our proposal “Development of novel pharmacotherapy to prevent development of severe conditions in patients with COVID-19 and to improve long-term prognosis, and its companion diagnostics” was awarded R&D grant by the Japan Agency Medical Research and Development (AMED).

Link: https://www.amed.go.jp/koubo/01/06/0106C_00038.html

The development of effective treatment for COVID-19 is an urgent global matter. ARTham along with our collaborators is striving to establish an early diagnosis to identify high risk COVID-19 patients getting severe condition and develop an effective treatment to prevent development of severe conditions and to improve long-term prognosis.

ARTham Therapeutics has reached an important milestone within our clinical stage portfolio. As planned, we are pleased to announce initiation of phase-I clinical trial for PI3K inhibitor ART-001 in Japan. This is a randomized, placebo-controlled, double-blind, single-center study to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of ART-001 in Japanese healthy volunteers.

For more information about the study, please visit the following website:

https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?clinicalTrialId=30973

Post successful Ph1, ART-001 will enter Ph2 (hPOC) studies for vascular malformations, with focus on treating pediatric rare indications that address significant unmet medical need. At ARTham Therapeutics our mission is to deliver “Medicines that matter” to patients and this milestone exemplifies that commitment.

Contact information: info@arthamther.com

ARTham’s clinical program: ART-648, oral selective PDE4 inhibitor, for pemphigoid was awarded three-year R&D grant from the Japan Agency for Medical Research and Development (AMED) Program for Orphan Drugs prior to Designation”.

https://www.amed.go.jp/en/program/list/06/03/001_03-01.html

Pemphigoid, one of the rare diseases in elderly population, is an autoimmune skin disease that causes edematous erythema, itchy blisters, and erosions of the skin and mucous membranes throughout the body. ART-648 is providing therapeutic benefits through inhibiting inflammatory responses in multiple immune and inflammatory cells. With the support from AMED, we will strive to deliver medicines that matter for patients.

YOKOHAMA, February 12, 2019 – ARTham Therapeutics, Inc., a clinical stage biopharmaceutical company that will deliver “medicines that matter” for patients, will present preclinical data on ART-648, an investigational phosphodiesterase type 4 (PDE4) inhibitor in a poster session at the European Association for the Study of the Liver, The International Liver Congress (ILC 2019), taking place in Vienna, Austria, April 10-14, 2019. ART-648 is a first-in-mechanism, orally-available, selective and potent inhibitor of PDE4 in development for the treatment of non-alcoholic steatohepatitis (NASH). Details of the poster presentations are as follows:
Title: Anti-metabolic, anti-inflammatory and anti-fibrotic properties of ART-648, a novel phosphodiesterase 4 inhibitor as a potential clinical candidate for non-alcoholic steatohepatitis
Location: Reed Messe Wien Congress and Exhibition Center, Vienna, Austria
Date & Time: Saturday, April 13, 9:00 – 17:00

About NASH
NASH is a progressive form of non-alcoholic fatty liver disease (NAFLD) with patients that advance to fibrosis due to inflammatory processes that result into cirrhosis or liver cancer. NASH is expected to be the most frequent reason for liver transplant by 2020. There is no approved pharmacotherapy for NASH. Although it is difficult to obtain an accurate estimate of NASH prevalence given the fact that NASH is a silent disease, there is a report that the global prevalence of NAFLD is as high as one billion. In the United States, NAFLD is estimated to be the most common cause of chronic liver disease, affecting between 80 and 100 million individuals, among whom nearly 25% progress to NASH (World J Gastroenterol 2017, 23: 8263-8276).

About ART-648
ART-648 is a first-in-mechanism, small molecule inhibitor of PDE4 in development to treat NASH. ART-648 potently and selectively inhibits PDE4 enzyme and is shown its direct anti-inflammatory, anti-metabolic- and anti-fibrotic via cAMP elevation in multiple disease relevant in vitro and in vivo models. ART-648 possesses superior physico-chemical properties combined with clinical and safety data analyses indicating tolerability profile similar or better to marketed PDE4 inhibitors. Ph1 clinical trial is currently being conducted in Japan, entering Phase 2a in 2H2019.

About ARTham Therapeutics
ARTham Therapeutics is a clinical stage biopharmaceutical company that will deliver “medicines that matter” for patients, with a compelling portfolio developed through unraveling hidden value of existing pharma assets. ARTham is a virtual R&D company that seeks the best academic and business partners to rapidly develop high value clinical candidates. The company is headquartered in Yokohama, Japan. For more information, please visit https://www.arthamther.com/en/

Contact
Tel: +81-45-225-8858
info@arthamther.com

ARTham Therapeutics Inc. (“ARTham”) was launched in Japan on July 1, 2018 with a compelling portfolio developed through unraveling hidden value of existing pharma assets.

“ARTham, which in Sanskrit means “deep meaning and value”, highlights the pharma R&D as a fine art. We are very excited to generate new ‘medicines that matter for patients’ through deeper understanding of science” said Dr. Sham Nikam, CEO of the company, who in the past led the Entrepreneurship Venture Program (EVP) with Dr. Hiroshi Nagabukuro (ARTham’s COO/CSO), at Takeda Pharmaceuticals, Japan. Takeda launched EVP initiative to promote entrepreneurship at Japan R&D sites.

ARTham is a virtual R&D company that seeks the best academic and business partners to rapidly develop high value clinical candidates. Founding members consists of leaders with global scientific and management experience, Dr. Sham Nikam, Dr. Hiroshi Nagabukuro, and Akira Tanaka (Senior Director) with scientific and clinical advice from Dr. Naoto Uemura, Professor, Clinical Pharmacology, Oita University.

The initial assets are in-licensed from Takeda, and include preclinical and clinical candidates for the treatment of inflammatory, fibrotic disorders such as non-alcoholic steatohepatitis (NASH), vascular malformations, endometriosis, cancer and psoriasis. The portfolio will grow through global strategic partnerships with pharmacos, and academic, scientific as well as governmental organizations. “The strategic collaborations and partnerships will drive the success of the company. For example, active collaborations with Clinical Pharmacology Center of Oita University Hospital, led by Dr. Uemura will facilitate and enable critical decision-making at Phase 1/Phase 2 clinical trials”, said Dr. Nagabukuro. On September 14, 2018, Clinical Trial Notification (CTN) for ARTham’s first candidate ART-648 for NASH treatment was approved by the Pharmaceuticals and Medical Devices Agency, Japan. Phase I trial for ART-648 will start in January 2019 as investigator-initiated study conducted at Oita University Hospital. The second clinical program for vascular malformations is in pre-CTN/IND stage. Program was awarded a research grant from Japan Agency for Medical Research and Development (AMED) in collaboration with academic investigators.

ARTham has obtained series A investments from investor syndicate comprising of Miyako Capital (lead investor), Takeda, SMBC Venture Capital, Mizuhoo Capital and Oita Venture Capital. Dr. Hiroyuki Misawa, Partner of Miyako Capital and Prof. Seigo Kitano, President of Oita University, have strongly endorsed this venture as one of the unique business-academia collaborations in Japan.