Zywie is pursuing approval for Ziva as a treatment for Type 3 Gaucher Disease (“T3 GD”) based on the results of pivotal clinical trials with a well-defined primary endpoint.
- Zywie believes that it has designed a clinical study that will provide sufficient data on the safety and effectiveness of Ziva to support a near-term decision on its approvability for marketing as a new treatment for T3 GD.
- To minimize the risk of delay, Zywie will proceed with two pivotal studies (each with 25 subjects in the target age range) and plan to file for approval based on the results of the first pivotal study.
Zywie is also evaluating the potential to pursue other indications, including:
- Type I Gaucher Disease (a substantially larger market than Type 3 GD because there are about 20 times more patients with T1 than with T3 GD)
- Lewy Body Dementia (a subset of Parkinson’s Disease with significant neurological symptoms)
- Other subsets of patients with Parkinson’s Disease (which has a similar disease mechanism that is likely to respond to treatment with Ziva).
Zywie’s predecessor, ExSAR, used its proprietary Hydrogen/Deuterium Exchange (H/D-Ex) Chromatography to evaluate a range of approved therapeutics for their binding characteristics with one another. This screening process yielded several promising candidates for the treatment of LSDs with unmet clinical need.