News Release

Posted date:

ARTham Therapeutics Presents Phase I Results for both ART-001 and ART-648 at ASCPT 2021 Annual Meeting

YOKOHAMA, January 15, 2021 – ARTham Therapeutics, Inc. will present Phase I results for both ART-648, an investigational PDE4 inhibitor, and ART-001, an investigational PI3Kα inhibitor in a poster session at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2021 Annual Meeting (March 8-17, 2021). ART-648 is an orally-available, selective and potent inhibitor of PDE4 in development for the treatment of bullous pemphigoid and COVID-19. ART-001 is an orally-available selective PI3Kα inhibitor in development for the treatment of slow-flow vascular malformations. Details of the poster presentations are as follows:

Abstract title: PII-040 – The novel PDE4 inhibitor ART-648 exhibits robust target engagement at clinically safe and tolerated doses identified in healthy subjects

Abstract title: PII-041 – Safety and pharmacokinetics of novel PI3Kα inhibitor ART-001 in oral pediatric formulation for the treatment of vascular malformations

Session title: Interactive Poster Hour II

Date & Time: Friday, March 12, 6:00 – 7:00 pm (EST)

 

About ART-648

ART-648 is an orally-available PDE4 inhibitor that is currently under development for bullous pemphigoid and COVID-19. ART-648 potently and selectively inhibits PDE4 enzyme and exhibits direct “anti-inflammatory,” “antimetabolite,” and “antifibrotic” effects in multiple disease relevant in vitro or in vivo models. In addition, ART-648 possesses superior physico-chemical properties, which contribute to tolerability profile similar or better to marketed PDE4 inhibitors. Phase IIa trials are scheduled to initiate in late 2021.

 

About ART-001

ART-001 is an orally-available PI3Kα inhibitor that is currently under development for low-flow vascular malformations. ART-001 potently and selectively inhibited PI3Kα and exhibits “antitumor effect” and “anti-angiogenesis effect” in in vitro and in vivo preclinical models. In addition, the excellent pharmacokinetic and safety profile with the new formulation was demonstrated in the Phase I study in healthy adults. The new formulation will also enable administration in pediatric patients. Phase IIa trials are scheduled to initiate in late 2021.

 

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


Posted date:

Series B round financing to unveil proof-of-concepts of both ART-648 and ART-001 programs

YOKOHAMA, January 15, 2021 – ARTham Therapeutics Inc. (“ARTham”), a clinical stage biopharmaceutical company, has raised 590 million JPY (approx. $5.7 million) in Series B financing lead by Miyako Capital and joined by additional investors including Takeda Pharmaceutical Company, SMBC Venture Capital, Mizuho Capital, Oita Venture Capital and Yokohama Capital.

 

Phase I clinical trials for both ART-648 and ART-001 have been successfully completed and Phase II trials for these programs are planned to initiate during the second half of 2021. The funds accelerate ARTham’s R&D towards achieving clinical POC of ART-648 and ART-001 for bullous pemphigoid and slow-flow vascular malformations, respectively.

 

 

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


Posted date:

ARTham is awarded an AMED grant for its new COVID-19 program

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.


Posted date:

ARTham Therapeutics has initiated a phase-I clinical trial on PI3K inhibitor ART-001

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


Posted date:

ART-648 program was selected as a drug discovery project for orphan diseases to be supported by AMED

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.