- European Commission designated Orphan Drug status for ATH434's treatment of Multiple System Atrophy in the European Union
- Phase 2 preparatory work continues
- Cash balance of $10.4M
MELBOURNE, Australia and SAN FRANCISCO, April 30, 2020 /PRNewswire/ -- Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company") releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 March 2020 (Q3 FY20).
In January the company announced that the European Commission (EC) designated the company's lead compound ATH434 (formerly PBT434) as an Orphan Drug for its treatment of Multiple System Atrophy (MSA). The designation entitles Alterity to 10 years of market exclusivity in the European Union for the use of ATH434 in the treatment of MSA, among other benefits. This designation follows granting of orphan drug designation by the US Food and Drug Administration (FDA) in 2019.
During the quarter the company continued advancing its Phase 2 clinical program of ATH434 in MSA, including preparation for the company's Pre-IND Meeting with the US FDA, which will determine steps required for the commencement of a Phase 2 clinical trial.
In addition to ATH434, the company continues to explore non-neurological options for the zinc ionophore PBT2, including potential use as an antimicrobial agent.
The impact of COVID-19 on the company has been limited to date. Nonclinical, drug manufacture and drug discovery programs have continued with minimal disruption. Slowdown in collaborative research activities do not have a material impact on the company's operations. All company employees are working remotely with no issues.
Authorisation & Additional information
This announcement was authorised by Geoffrey Kempler, CEO and Chairman of Alterity Therapeutics Limited.