US-based CuraSen Therapeutics plans to initiate a first-in-human clinical trial with new neurodegenerative disease drug CST-3056 in Q4 2024, CEO Dr Anthony Ford told Clinical Trials Arena.
The biopharma company recently received $5.8m in funding from the Alzheimer’s Drug Discovery Foundation. The funds will cover nonclinical safety studies, which are expected to begin in early 2024, and the first Phase I clinical trial later in the year, Ford explained.
The upcoming Phase I single ascending and multiple ascending dose study will evaluate the safety and pharmacokinetics of CST-3056. CST-3056 is an alpha-1A adrenoceptor (α1A-AR) agonist.
CuraSen is yet to decide where the single-site trial will take place, with possible options inside or outside of the US. Ford noted that the protocol will be submitted in mid-2024.
The trial will mainly recruit healthy volunteers, but the last cohort will include patients from the target population. Ford said that it may be Alzheimer's disease patients or people with mild cognitive impairment that precedes Alzheimer's disease.
“The goal is to make sure that the drug is just as safe and well tolerated in the population that we are targeting as it is in the healthy subjects,” he added.
In total, the trial will recruit approximately 100 participants.
Additionally, CuraSen is likely to evaluate the drug’s impact on brain function. For example, tests that would measure blood flow changes or brain activity, or a cognitive test to evaluate the attentiveness and memory in the target population.
Ford explained that such tests will help to understand not only if the drug is reaching the brain, but also if it produces manifestation of a beneficial effect.
Upcoming Phase II trial with CuraCN
CuraSen will also conduct a Phase II trial in Parkinson’s disease with CuraCN, a combo treatment of clenbuterol and nadolol, in mid-2024. In a March press release, the company outlined its plans to conduct the trial this year, but the study got pushed to the following year due to delays in other clinical trials.
This will be a 12-week, placebo-controlled, multi-centre study with sites across several European countries, as well as Australia and New Zealand. CuraSen is doing additional power calculations to determine the ultimate cohort size but plans to enrol at least 120 Parkinson’s patients with significant non-motor symptoms.
The goal of the study is to advance from the data presented earlier this year and show that CuraCN produces improvements in both memory and cognitive function, in addition to markers of mood in patients with Parkinson's disease.
Before moving to a Phase III trial with CuraCN, CuraSen will conduct another smaller Phase II dose selection trial. This study is likely to occur halfway through the 12-week Phase II trial, with both studies expected to be completed by the end of 2026, Ford noted.
