CN128 / Hangzhou Zede Pharma - LARVOL DELTA

Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients (clinicaltrials.gov) - P2 | N=16 | Completed | Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd. | Recruiting ➔ Completed | N=50 ➔ 16

Enrollment change • Trial completion • Genetic Disorders • Hematological Disorders

Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd. | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Oct 2024

Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders

Long-term Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd. | Phase classification: P2a ➔ P2

Phase classification • Genetic Disorders • Hematological Disorders

Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd. | Phase classification: P2b ➔ P2

Phase classification • Genetic Disorders • Hematological Disorders

Long-term Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P2a | N=18 | Completed | Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd. | Active, not recruiting ➔ Completed | N=50 ➔ 18 | Trial completion date: Aug 2022 ➔ Nov 2022 | Trial primary completion date: Aug 2022 ➔ Nov 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders

Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients (clinicaltrials.gov) - P2b | N=50 | Recruiting | Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Hematological Disorders

Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients (clinicaltrials.gov) - P2b | N=50 | Not yet recruiting | Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd.

New P2b trial • Genetic Disorders • Hematological Disorders

Long-term Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P2a | N=50 | Active, not recruiting | Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2022 ➔ Jun 2022

Enrollment closed • Trial primary completion date • Genetic Disorders • Hematological Disorders

Effectiveness of the Iron Chelator CN128 in Mitigating the Formation of Dopamine Oxidation Products Associated with the Progression of Parkinson's Disease. (PubMed, ACS Chem Neurosci) - "As such, one of the proposed therapeutic strategies has been the use of iron chelators such as deferiprone (DFP) (which is recognized to have limitations related to its rapid degradation in the liver) to reduce the concentration of labile iron. CN128 is superior to DFP with regard to the reduction in formation of DAC and elevation in DA concentration. In summary, the results of this study suggest that prodromal application of the chelator CN128 could be effective in preventing the onset and slowing the early stage development of PD symptoms associated with oxidants and toxic intermediates resulting from the iron-mediated oxidation of the neurotransmitter dopamine with CN128 likely to be superior to DFP in view of its greater in vivo availability and less problematic side effects."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Long-term Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P2a; N=50; Recruiting; Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd.

Clinical • New P2a trial • Genetic Disorders • Hematological Disorders • MRI

CN128, a new orally active hydroxypyridinone iron chelator. (PubMed, J Med Chem) - "Deferoxamine, deferiprone, and deferasirox are used for the treatment of systemic iron overload, although they possess limitations due to lack of oral activity, lower efficacy, and side effects. The Fe(III) affinity and metal selectivity of CN128 are similar to those of deferiprone, the logP value is more lipophilic, and its iron scavenging ability is superior. Overall, CN128 was demonstrated to be safe in a range of toxicity assessments and is now in clinical trials for the treatment of β-thalassemia after regular blood transfusion."

Journal • Genetic Disorders

Short-term Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd.; Trial completion date: May 2019 ➔ Dec 2019

Clinical • Trial completion date • F2

Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd.; Recruiting ➔ Completed; N=47 ➔ 32

Clinical • Enrollment change • Trial completion • F2

[Roadshow] Zede Medicine: Independent intellectual property rights drugs won the ‘Twelfth Five-Year’ special support [Google Translation] (Shenzhen Panorama Network) - "...CN128 is Zede Pharmaceuticals has innovative intellectual property rights and can be used in the treatment of a variety of iron overload related diseases. It has been specially supported by major national new drug creations in the 'Twelfth Five-Year Plan' and has obtained patents in China, the European Union and Hong Kong."

Financing

Short-term Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd.; Recruiting ➔ Completed; Trial completion date: Dec 2019 ➔ May 2019

Clinical • Trial completion • Trial completion date

Short-term Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd.

Clinical • New P1 trial

Clinical Study of CN128 in Thalassemia Patients (clinicaltrials.gov) - P1; N=47; Recruiting; Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd.; Trial completion date: Dec 2018 ➔ Dec 2019

Clinical • Trial completion date