Prana Business Update
Prana today provided a business update on its development portfolio of potential neurodegenerative treatments.
Prana has met with the Medical and Healthcare Regulatory Agency in London and the Medical Products Agency in Stockholm to clarify the next steps required to start a Phase 3 trial in Huntington disease. Both agencies were encouraging of Prana’s development program for PBT2 but recommended further non-clinical work be undertaken and completed to establish the reversibility of the neurotoxicity effects seen in a dog study before further consideration of the Phase 3 trial.
Prana is determining the optimal commercialisation pathway of PBT2 including securing a collaboration to undertake the further non-clinical work needed to pave the way to start a Phase 3 Huntington disease trial, the use of PBT2 at lower doses (as currently permitted by the FDA), or using PBT2 for acute indications requiring shorter term use, all with the aim of realising shareholder value from this part of its IP portfolio.
At the same time, Prana has continued to develop PBT434 for the treatment of Parkinson’s disease and Parkinsonian syndromes. PBT434 is designed to inhibit the neurotoxic build-up of alpha synuclein and tau proteins in the brain and has shown strong neuroprotective effects in five different robust preclinical mouse models, reducing cell death by up to 80%. PBT434 has also shown direct beneficial effects on motor and cognitive function in various models of Parkinsonian synucleinopathies and tauopathies. Prana is also completing an IND-enabling package to support a Phase 1 program.
Prana has a proprietary library of over 1000 novel Metal-Protein Attenuating Compounds (MPACs) available for screening and assessment for therapeutic applications in neurodegenerative diseases. This includes PBT519 which is being considered as a treatment for brain cancer.
As previously announced, Prana has commenced a process of reviewing other potentially suitable opportunities that may be highly attractive and can add significant shareholder value in the medium to longer term. The Company currently retains cash reserves of approximately A$29 million.