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KDDF-201606-03 New Botanical Drug Development for Alzheimer's disease in the U.S.(CNS Diseases, Natural) [11.01.2016]

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Development and Market Objectives

Completion of preclinical study and early phase IND approval in U.S.

DA-9803 is a preclinical candidate for the treatment of Alzheimer disease (AD) and it has putative efficacies of inhibiting the accumulation of beta amyloid (Aβ) and tau phosphorylation and also improving cognitive function. To confirm its probability as a disease-modifying drug, we aim to develop a biomarker clinical protocol and receive early phase IND approval in U.S.

Unmet Medical Need & Target Patients

Target patients

- 68.4 % of patients with AD (including MCI) are classified as mild to moderate AD patients and are highly marketable (Datamonitor, 2012).

- DA-9803 mainly targets mild and moderate AD patients as they can be treated with the administration of disease-modifying drugs. Even if they show cognitive impairment, the extent of damages to their brain cells is recoverable.

- On the basis of clinical outcomes, the indication could be expanded to MCI, the pre-onset stage of AD.

 

Unmet medical needs

- The prevalence rate of AD surges with population aging, which is expected to trigger severe social problems and increase social costs rapidly. The number of Korean AD patients is estimated to be 1.27 million in 2030 and 2.71 million in 2050, doubling every 20 years (Ministry of Health and Welfare-designated Clinical Research Center for Dementia).

- The number of U.S. Alzheimer patients is predicted to increase from 3.7 million in 2014 to 6.5 million in 2034 (Datamonitor, 2015).

- Current treatments including Donepezil are all symptomatic treatment and show temporary improvement in cognition in AD patients.

- Therefore, the unmet need for drugs delaying the progression of AD or holding disease-modifying effect is quite high.

- Lundbeck’s Idalopirdine, under development as a symptomatic therapy, is predicted to be launched in 2018 and generate 540 million dollars in sales. On the other hand, Solanezumab, a disease-modifying pipeline of Eli Lilly, will be introduced in 2018 and is estimated to record 4.64 billion dollars in sales, sharing half of the total market (Datamonitor, 2014).

Status

- The efficacy of the two botanical raw materials was confirmed respectively and synergistic effect of DA-9803, a combined extract of them, was verified. The optimal candidate was derived from mixing ratio study and process research.

- Based on previous projects which are in P2 or already completed P2 in U.S., Dong-A ST has secured advanced CMC technologies (totality-of-the-evidence).

- In preclinical studies, administration of DA-9803 evidently improved cognitive function and protected nerves by decreasing Aβ and inhibiting phosphorylation of tau protein in Aβ infusion model and transgenic animal models (APPSwe, APPSwe/PS1, 3XTG, 5XFAD).

- The collaborative research with Harvard University possessing advanced technologies regarding AD study showed that DA-9803 decreased the level of Aβ plaques and inhibited Ca overload.

- Management of raw botanical materials and compound, study of stability and dosage form, and safety test were performed and fine research results were secured. The additional preclinical studies for early phase IND in U.S. are now in progress.

Intellectual Property

- A patent was applied on the individual botanical raw material.

- A patent was applied and registered on DA-9803.

- PCT was also applied on the above two patents.

Patent

Nation

Application number

Patent number

Filing date

Single raw material patent

Korea

10-2014-0184853

 

2014. 12. 19

PCT

PCT/KR2015/013136

 

2015. 12. 3

DA-9803 patent

Korea

10-2014-0184854

10-1671437

2014. 12. 19

(Registration date 2016. 10. 26)

PCT

PCT/KR2015/013134

 

2015. 12. 3

Competitive Advantages

Unmet needs satisfaction and achievement of competitiveness

- The major unmet need resulting from current AD therapies is disease-modifying efficacy. And cognitive improvement is also necessary to increase clinical success rate.

- DA-9803 improves the disease by decreasing the main causes of AD, Aβ and pTau, which consequently leads to market competitiveness.

- Other pipelines with disease-modifying effect could have MoA-specific side effects and the unit costs of production of some candidates are expected be high. However, the preclinical study of DA-9803 showed its putative high level of safety and this compound can be supplied at low costs.

- Cognitive improvement in scopolamine induced memory impairment model and inhibitory effect on AChE were verified in preclinical studies. Thus, the clinical success rate of DA-9803 is anticipated to be high compared to other pipelines.

 

License-Out after biomarker early clinical trial

- As the endpoint of general AD clinical studies is cognitive function, large-scale patient recruitment demanding high cost is required and disease-modifying efficacy is hard to prove.

- Dong-A ST is planning to test disease-modifying effect of DA-9803 in a small-scale biomarker clinical trial and U.S. is suitable site due to its high capability of biomarker clinical study.

- The network with local clinical specialists of Harvard University and Johns Hopkins University was already established and by cooperating with them we plan to compose an optimal clinical protocol of DA-9803. If an early phase confirms its efficacy, future development could proceed with breakthrough of FDA.

- If an early biomarker clinical study succeeds, license-out or joint development could be accomplished on favorable terms. Considering the marketability of AD, active partnering seems to be desirable at the early stage of development.

Indication

Alzheimer

Research Period

Oct. 25, 2016 ~ Apr. 24, 2018

Company

Dong-A ST

Developmental Stage

Preclinical

Additional Information

Contact Information

Contact
Address Company Name: Dong-A ST
WebSite Homepage: http://www.donga-st.com Contact Person: Hyo Sang Go, Hye Yeon Soh
E-mail: go_hs@donga.co.kr, gpdus67@donga.co.kr Contact: 031-280-1369, 031-280-1397

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