Alterity Therapeutics Ltd.

11/18/2019 | News release | Distributed by Public on 11/17/2019 20:05

Alterity’s lead drug candidate receives positive opinion from European medical agency

Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ('Alterity' or 'the Company') has received a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products (COMP) on recommending the designation of its lead molecule PBT434 for the treatment of Multiple System Atrophy (MSA) as an orphan medicinal product to the European Commission (EC).

Following the finalisation of relevant documents, COMP has forwarded the opinion to the EC for its decision on the recommendation.

'We are pleased to receive the positive opinion from COMP for PBT434 as a potential treatment for MSA in Europe,' said Geoffrey Kempler, CEO of Alterity. 'Europe is a key market for Alterity, and it will lay the foundation for the Company to expand the use of PBT434 into other markets. We look forward to hearing more from the EC on their decision and will keep our stakeholders updated on progress.'

In January this year, the US Food and Drug Administration (FDA) granted PBT434 orphan drug status for the treatment of MSA.

Phase 1 clinical trial results for PBT434 were announced in July. PBT434 was found to be safe and well-tolerated in adult and older adult (≥ 65 years) subjects with an adverse event profile comparable to placebo. The clinically tested doses achieved concentrations in brain that are potentially clinically relevant.

PBT434 looks to treat Parkinsonian disorders such as Parkinson's disease (PD) and MSA. These neurogenerative diseases result from accumulation of aggregated alpha-synuclein protein. PBT434 was found to inhibit the alpha-synuclein aggregation, preserve neurons and improve motor function in pre-clinical models of PD and MSA.



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