MA-T® drug development from long-term perspective
MA-T® has a great deal of potential to develop a range of drugs such as anticancer agents.
We show MA-T® R&D in medical and new drug development, which directly affect people's health and MA-T® drug development and moves toward approval.
Moves toward approval
MIn preliminary discussions, the Pharmaceutical and Medical Devices Agency (PMDA) said MA-T® counts as a novel substance. Approval as a drug involves a full set of procedures. We have since consulted the Ministry of Health, Labour and Welfare and others, and are proceeding on the best route.
Japan MA-T Industrial Association member HOIST Co. Ltd. is developing an MA-T® anticancer agent. It has already received two funding rounds from OSAKA University Venture Capital Co., Ltd. Its first plan is to develop a bladder cancer treatment drug.
Data showing the effectiveness of the key ingredient was obtained both in vitro and in vivo. The team is considering the optimal value for clinical dose design. Preclinical toxicity studies have shown no serious side effects. Other steps toward drug approval, such as GMP (good manufacturing practice) compliance are going smoothly. The company plans to launch clinical trials 2023 year.
Drug Working Group
Apart from the anticancer agent, MA-T® has potential for a range of drug developments which researchers at Osaka University and others are engaged in. We understand that HOIST is the only one of our members developing MA-T® drugs. We are looking forward to drug companies joining our association.
We are looking into establishing a Drug Working Group organized around quasi-drugs in addition to pharmaceuticals. The health ministry thinks quasi-drug approval is needed following drug approval, so strategies must be long-term. We think that arrangements enabling the sharing of preclinical study information acquired in drug regulatory approval for applications the near term would prove extremely useful.
The information would accelerate development, reduce costs, and lower risks for companies involved in drug discovery. HOIST, which is spearheading initiatives, would be able to monetize its information and improve its financial position. Our association would like to support MA-T® drug development through open innovation under the framework of a drug working group.