Herantis Pharma announces, they expect regulatory approval in Q4 2022 to start a first-in-man clinical study of HER-09

Herantis Pharma announces that they expect to file for regulatory approval in Q4 2022 to start a first-in-man clinical study of HER-09 (a small molecule synthetic peptidomimetic of CDNF being developed for #Parkinsons)

herantis.com/press-releases...

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FYI. ncbi.nlm.nih.gov/pmc/articl...

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Herantis Pharma Plc ("Herantis"), focusing on disease modifying therapies for debilitating neurodegenerative diseases, gives a 2021 year end summary of the progress of the company and the plans for 2022.

Herantis has two programs under development:

1. rhCDNF (recombinant human Cerebral Dopamine Neurotrophic Factor), a biotechnological protein that has been used safely in a Phase I study (intracranial administration via surgery) in patients with Parkinson's disease and is now being developed for intranasal brain administration via simple nasal spray

2. HER-096, an advanced small synthetic chemical peptidomimetic version of the active parent rhCDNF protein. It combines the compelling MoA of rhCDNF protein and the ability to be delivered to the brain after simple skin injection

For 2021 the highlights were:

evidencing the true disease-modifying potential of rhCDNF and HER-096 for Parkinson's disease

confirmation of the long-term safety of intraputamenal rhCDNF

confirming the impact of rhCDNF and HER-096 on biomarkers of Parkinson's disease

identification of novel biomarker candidates to accelerate future clinical development in Parkinson's

affirming that HER-096 can impressively cross the blood brain barrier and enter the brain

demonstrating that HER-096 induces unequivocal protection and restoration of neurons in preclinical models of Parkinson's disease

establishing a respected and internationally renowned Scientific Advisory Board

For 2022 the main objectives will be:

successful completion of HER-096 non-clinical program to support the first-in-human study

filing for regulatory approval to start a first-in-human study with HER-096

defining the patient population for further clinical development

confirmation of feasibility of rhCDNF brain distribution following intranasal spray administration