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Statement
| 1.Date of occurrence of the event: 2022/08/10
2.New drug name or code: FP-045, an ALDH2 activator
3.Indication: for the treatment of Fanconi anemia
4.Planned development stages: to conduct phase 2 and phase 3 clinical trials
and submit New Drug Application
5.Current development stage:
(1) Application submission/approval/disapproval/each of clinical trials
(include interim analysis):
TRPharm, Foresee's licensing partner, has submitted a Proof-of-Concept
study IND (Investigational New Drug) application to the Ministry of
Health of Turkey for FP-045 in patients with Fanconi anemia.
(2) Once disapproved by competent authority or each of clinical trials
(include interim analysis) results not reached statistically
significant sense, the risks & the associated measures the Company
may occur: N/A
(3) After obtaining official approval or the results reaching statistically
significant sense, the future strategy: N/A
(4) Accumulated investment expenditure incurred: Undisclosed
6.Upcoming development plan:
(1) Estimated date of completion: at authorities' discretion. Material
information will be announced after receiving clinical trial approval.
(2) Estimated responsibilities: R&D expenses for conducting this clinical
trial
7.Market situation:
Fanconi anemia (FA) is a rare inherited disease caused by genetic defects
in the DNA repair protein group. The majority (60 - 70%) of FA is
attributable to mutations of the FANCA gene. The symptoms of FA patients
vary widely and are often characterized by bone marrow failure, various
types of physical abnormalities, and/or an increased risk of malignancy.
The incidence of this disease is about 1/130,000 in the United States.
The most significant early manifestations of FA are hematologic
abnormalities. Between 80% of patients will develop bone marrow failure
in their second decade of life. Up to 98% of patients will develop
symptoms related to blood abnormalities and a variety of disorders, most
will develop cancer.
The market value of Fanconi anemia is estimated by various adjuvant
therapy, diagnosis, care and treatment of various derived disorders.
According to Data Bridge Market Research, the Fanconi anemia treatment
market was valued at US$ 520 million in 2021 and is expected to reach
US$ 810 million by 2029, with a CAGR of 5.70%.
Recent animal studies have found that ALDH2 deficiency accelerates the
development of bone marrow failure in mice, which is also a phenomenon
confirmed in patients with Fanconi anemia. FP-045 - a highly soluble
and orally available prodrug of a potent and highly selective ALDH2
activator, increases ALDH2 activity in FANCA-deficient lymphocytes in
vitro, and has the potential to treat fanconi anemia or to slow down the
progression of bone marrow failure in patients. Currently, there is no
medicine on the market to cure fanconi anemia or to slow down the
progression of the disease. If successfully developed, FP-045 will
become the first and only drug in the world for the treatment of fanconi
anemia.
8.Any other matters that need to be specified: None
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.:
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