Denali Therapeutics has started dosing of subjects in a Phase I/II clinical trial of DNL593 to treat frontotemporal dementia-granulin (FTD-GRN).

Developed by the company’s Protein Transport Vehicle (PTV) technology, DNL593 is an investigational, brain-penetrant recombinant progranulin (PGRN) replacement therapy.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Denali entered a strategic collaboration with Takeda to jointly develop and commercialise DNL593, which is intended to slow or prevent FTD-GRN progression by increasing intracellular and extracellular functional PGRN levels.

The randomised, multicentre, placebo-controlled, double-blind Phase I/II study is designed to evaluate DNL593’s pharmacokinetics, pharmacodynamics, tolerability, and safety in healthy subjects and FTD-GRN patients.

Denali Therapeutics chief medical officer Carole Ho said: “Denali has a diverse portfolio of therapeutic candidates to address neurodegenerative and lysosomal diseases, and DNL593 is our second Transport Vehicle (TV) technology-enabled programme to enter clinical development.

“Initiation of this Phase I/II trial is an important development milestone for the programme, and we look forward to continued collaboration with Takeda and the FTD community in our unified purpose to develop DNL593 as a treatment option for people and families living with FTD-GRN.”

The trial is a three-part (Parts A-C) study, and subject dosing has commenced in the single ascending dose Part A in healthy participants.

The multiple dose, 25-week Part B study will be conducted in FTD-GRN patients, and the 18-month open-label Part C study is the extension of FTD-GRN patients who participated in Part B.

FTD-GRN is characterised by a deficiency of progranulin (PGRN) in the brain. In 2019, Denali commenced patients’ dosing in a Phase Ib clinical trial of DNL151 to treat Parkinson’s disease.