Advanced BioDesign hopes the second stage of its study will confirm the efficacy of drug candidate ABD-3001 on target enzyme ALD1H. Credit: Nemes Laszlo via Shutterstock.

Advanced BioDesign has released the first data from its ODYSSEY study evaluating the potential of its drug candidate ABD-3001 (Sefaldin) in treating acute myeloid leukaemia (AML) in relapsed patients who have proven resistant to standard therapies.

ABD-3001 is a galenic form of Dimate, a first-in-class suicide inhibitor of the study’s target enzyme, aldehyde dehydrogenase 1 (ALDH1).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Initiated 15 months ago, the Phase I/II study has an adaptive design with an initial single ascending dose in six patient cohorts.

Preliminary signs of Sefaldin’s efficacy on ALDH1 have been observed in more than 65% of patients treated.

Biological activity markers – the inhibition of target enzyme ALDH1A1 activity and c-Jun N-terminal kinases (JNK) protein phosphorylation – demonstrated the action of ABD-3001 from the first dose.

Overall, Sefaldin is safe and well tolerated in AML patients, with no major safety issues.

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.

Due to the encouraging observations in the study’s first stage, Marseille’s Timone Hospital head of haematology and lead investigator Regis Costello said the study group now plans to treat patients over three cycles to observe any strong signals of efficacy as it moves into the trial’s second stage.

Costello said there are also plans to apply to the authorities for a compassionate prescription scheme for two patients in the study in which a significant improvement in their haematological parameters was observed over three months after a single dose of Sefaldin.

In the second stage of the study, Advanced BioDesign CEO Ismail Ceylan said several treatment cycles will be evaluated at optimised dose regimens to “confirm ABD-3001’s position in the therapeutic arsenal” for the treatment of AML.

“By treating patients over three cycles, we are searching for reaching efficacy signals for overall response rate, as well as quality of life improvement,” Ceylan told Clinical Trials Arena.

“During our second phase, we will monitor the target engagement and early biological activity of the phosphorylation reaction in c-Jun N-terminal kinases (JNK).

“In addition, next-generation sequencing will be performed in order to understand the impact of ABD-3001 on leukaemic sub-population in order to find a possible pattern favourable to be treated with this inhibitor.”

Sefaldin is also currently in Phase I development for myelodysplastic syndrome and refractory AML.

The drug is also in the pre-clinical or earlier stages for six other indications, including breast cancer and melanoma, as per GlobalData’s pharmaceutical pipeline database.