DPX-101 will be evaluated for its potential to treat cognitive disabilities in major depressive disorder and other brain disorders. Credit: ESB Professional / Shutterstock.

The US Food and Drug Administration (FDA) has approved an investigational new drug (IND) application from Damona Pharmaceuticals, allowing it to begin a Phase I trial of DPX-101.

DPX-101 is a positive allosteric modulator that targets the α5-GABA-A receptor in the brain.

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The drug is designed to treat cognitive disabilities in major depressive disorder and other brain disorders.

The trial will assess the asset’s safety, tolerability and pharmacokinetic and pharmacodynamic characteristics in healthy individuals.

The first part of the trial will be a single-ascending dose study across five planned cohorts of participants, as well as a comparator cohort.

Subjects in the comparator cohort will receive the gamma-aminobutyric acid receptor subunit alpha-1 (α1-GABA-A) receptor agonist Zolpidem, to assess the selectivity of DPX-101 for the α5-GABA-A receptor.

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The trial’s second part will be a multiple-ascending dose study in which participants will be randomised into three escalating dose cohorts to receive daily doses of DPX-101 or placebo for one week.

The safety and tolerability of varying doses of DPX-101 are the trial’s primary endpoints, while its secondary endpoints will evaluate the asset’s pharmacokinetic profile.

Damona Pharmaceuticals CEO John Reilly said: “The FDA clearance of the DPX-101 IND allows us to initiate the Phase I clinical study of our lead asset, which promises to establish a new standard of care for the treatment of cognitive deficits associated with brain disorders.

“Based on data from our preclinical studies and the compound’s selectivity for α5-GABAAR, we believe that DPX-101 could benefit a broad range of patients suffering from diseases that cause cognitive impairment.

“We look forward to the planned initiation of our Phase I clinical trial later this year.”

Preclinical studies showed that DPX-101 exhibited highly selective activation of its target and the anticipated electrophysiological effects, as well as improving cognitive performance in behavioural tests for assessing functions of the frontal cortex and hippocampus.