News Release

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Kaken Pharmaceutical to acquire ARTham Therapeutics

Yokohama, Japan, November 30, 2021 – ARTham Therapeutics Inc. (Yokohama, Japan, CEO: Hiroshi Nagabukuro, “ARTham”) and the ARTham’s shareholders today entered into a share purchase agreement with respect to the acquisition of the ARTham by Kaken Pharmaceutical Co. LTD. (Bunkyo-ku, Tokyo, Japan, President and Representative Director: Hiroyuki Horiuchi, “Kaken”). As a result of this acquisition, ARTham will become a wholly-owned subsidiary of Kaken on a voting basis.

 

ARTham is a clinical stage biopharmaceutical company with its mission to deliver truly effective “medicines that matter” to patients with unmet medical needs. Through a rapid and efficient “virtual R&D operating model” based on collaboration with the best academia and business partners, we have advanced the R&D of our pipelines, ART-001 (slow-flow vascular malformation) and ART-648 (bullous pemphigoid). Currently, phase 2 clinical trials are being conducted to investigate the efficacy and safety of both compounds.

 

Kaken’s corporate philosophy is to “help improve the quality of life for patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals”. Since its establishment in 1948, Kaken has been engaged in the research and development of pharmaceuticals that meet the medical needs. In recent years, Kaken has been increasing its presence in the dermatology and orthopedics therapeutic areas, and its proprietary drug “Clenafin”, the first topical onychomycosis treatment in Japan, continues to grow as a global product.

 

After the acquisition, the two companies will collaborate on the development of ART-001 and ART-648 to ensure the success of the ongoing Phase 2 clinical trials. Upon successful phase 2 results obtained, Kaken will take over and pursue further research and development of these 2 assets including late-stage clinical development and global strategy. In addition to the development of ART-001 and ART-648, ARTham will contribute to the further enhancement of Kaken’s R&D capabilities by realizing synergies such as applying ARTham’s knowledge and experience in drug repositioning to Kaken’s existing compounds.

 

“We are very pleased to be collaborating with Kaken Pharmaceutical, which has been providing innovative medicines in the dermatology and orthopedics therapeutic areas, for the development of both ART-001 and ART-648. We have high expectations and strong confidence that these drug candidates, which were discovered through “virtual R&D” and “drug repositioning,” the cornerstones of our business model, will reach patients in the near future. As an Oita University-affiliated biotech company, we have been able to closely work together with many universities and research institutes on our R&D programs, which has been an essential driver in the successful progress of ART-001 and ART-648 to date.” said Hiroshi Nagabukuro, Representative Director and CEO of ARTham.

 

“This is a groundbreaking example of a drug-repositioning biotech start-up founded by Dr. Nagabukuro as a spin-out from a major pharmaceutical company. We have achieved the significant milestone only within 3.5 years having R&D strategy focusing on human proof of concept with this very strong team. we are in the business of maximizing the strength of our team specialized in acquiring human POC. I am confident that this will be one of the next major keys for the development of biotech in Japan.” said Hiroyuki Misawa, Director and Partner of Miyako Capital.

 

In accordance with the share transfer agreement, ARTham shareholders will receive an upfront payment of 55 oku yen (approx. US$48 million) from Kaken upon completion of the acquisition. In addition, depending on the progress of development in Japan and outside Japan, ARTham shareholders may receive up to approximately 72 oku yen (approx. US$63 million) by Kaken common stock in additional milestone payments.

 

Hiroshi Nagabukuro will continue to serve as Representative Director and CEO of ARTham after the acquisition. ART-002, another pipeline of ARTham, will not be included in the ARTham’s new pipeline lineup after the acquisition, and it will be transferred from ARTham to a new company to be established by Hiroshi Nagabukuro, before the closing of the acquisition.

 

The acquisition is expected to be completed by the end of year 2021, after the all-necessary procedures.

 

 

Contacts

TEL:045-225-8858

Email:info@arthamther.com


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ARTham announces first patient dosed in Phase 2 clinical trial of ART-648 in patients with bullous pemphigoid.

ARTham Therapeutics announced today that the first patient has been dosed in a Phase 2 clinical trial evaluating ART-648 as a potential treatment for bullous pemphigoid (jRCT2071210034). ART-648 is a novel orally available PDE4 selective inhibitor with excellent pharmacokinetic, pharmacodynamic and safety profile that have been demonstrated in its Phase 1 trial in healthy adults.

This Phase 2 trial is a multi-center, double-blind, placebo-control, randomized controlled study to evaluate the efficacy, safety, and pharmacokinetics of ART-648 in patients with bullous pemphigoid. The trial is enrolling a total of 30 patients. The primary endpoint of the trial is the proportion of patients achieving the cessation of new lesion formation (erosion/blister or wheal/erythema) without rescue therapy at week 4. Secondary endpoints include the proportion of patients achieving the cessation of new lesion formation without rescue therapy at week 2, changes from baseline to week 2 and 4 in bullous pemphigoid disease activity index (BPDAI) score, pruritus VAS score, and proportion of patients receiving rescue therapy at week 2 and 4.

 

About bullous pemphigoid

Bullous 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. Bullous pemphigoid is most commonly treated with oral or topical corticosteroids. Anti-inflammatory medications may also be useful in mild cases. Severe cases may require the use of immunosuppressant medications. Oral corticosteroids can have serious side effects, so there is high demand for an effective anti-inflammatory agent, which tapers regimen of corticosteroid.

 

About ART-648

ART-648 is an orally available PDE4 inhibitor that is currently under development for bullous pemphigoid. 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 demonstrated in its phase 1 study.

 

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


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ARTham announces first patient dosed in Phase 2 clinical trial of ART-001 in patients with slow-flow vascular malformations.

ARTham Therapeutics announced today that the first patient has been dosed in a Phase 2 clinical trial evaluating ART-001 as a potential treatment for slow flow vascular malformations (jRCT2071210027). ART-001 is a novel PI3Kα selective inhibitor with excellent pharmacokinetic and safety profile that have been demonstrated in its Phase 1 trial in healthy adults.

This Phase 2 trial is a multi-center, double-blind, randomized controlled study to evaluate the efficacy, safety, and pharmacokinetics of ART-001 in pediatric (≥ 2 years old) and adult patients with slow-flow vascular malformations including venous malformation, lymphatic malformation (lymphangioma) and Klippel-Trenaunay syndrome. The trial is enrolling a total of 34 patients. The primary endpoint of the trial is the proportion of subjects with response defined by MRI volumetric change of target lesion at Week 24. Secondary efficacy endpoints include the proportion of subjects with response at Week 12, changes from baseline in MRI volume of target lesion, pain VAS, QOL score and performance status.

 

About slow flow vascular malformations

Slow-flow vascular malformations are benign (non-cancerous) lesions that are present at birth, and may become visible for weeks or months after birth. Unlike hemangiomas, vascular malformations continue to grow slowly throughout life. It has been reported that most patients with slow-flow vascular malformation have a gain-of-function mutation in PI3K pathway, which plays an important pathological role in vascular malformation.

 

About ART-001

ART-001 is an orally-available PI3Kα inhibitor that is currently under development for slow-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.

 

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


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We are pleased to announce that Dr. Victor Stone from Takeda Ventures was elected and appointed as a new director at our Ordinary General Meeting of Shareholders on June 16, 2021.


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Website updated.