We talk to the CEO of Herantis Pharma Plc Antti Vuolanto about HER-096, a molecule which may have the potential to stop the progression of Parkinson’s and to relieve symptoms
A potential new disease-modifying Parkinson’s treatment achieved positive results when it was tested on humans for the first time, the clinical-stage biotechnology company Herantis Pharma Plc announced at the end of October.
With the aim of developing a medication that could slow or stop the progression of Parkinson’s and provide symptom relief, the Finland-based company began working on a molecule called HER-096 in 2018.
“At that time, we worked with a protein called CDNF, says Antti Vuolanto, CEO of Herantis Pharma, “and we wanted to find smaller molecules that would have the same activity but also have the ability to go through the blood/brain barrier, so we could use a patient-friendly administration route.”
Antti Vuolanto, CEO of Herantis Pharma Plc
Following a successful pre-clinical stage, in a Phase 1a clinical trial that took place earlier this year, HER-096 – which is administered by subcutaneous injection – achieved good results for safety and tolerability in 60 healthy people (without Parkinson’s) from three different age groups (20-45, 50-64 and 65-75 years). A major milestone for the drug’s development was achieved, as tests conducted in the second part of the trial, involving the 50-75 age group, proved that HER-096 is able to cross the blood/brain barrier.
A diagram explaining how Herantis Pharma Plc hopes HER-096 could have a therapeutic effect on the brains of people with Parkinson’s
“That has been one of the biggest challenges in Parkinson’s drug development,” says Vuolanto, “how to get the drug molecules into the brain, into the target tissue, as there is a mechanism of the blood/brain barrier that protects the brain from foreign substances. Now we have shown that, yes, we can cross that efficiently enough to deliver a therapeutic dose into the brain tissue.”
Further trials will be required to prove if HER-096 can have a therapeutic effect on those with Parkinson’s, but findings from the earlier, pre-clinical stage suggest that the potential benefits of HER-096 could be three-fold for people with the condition.
“In the scientific, pre-clinical testing stage, we have seen that it protects neurons, it decreases the amount of toxic protein aggregates – the alpha synuclein aggregates – and also removes neuro inflammation from the target area,” says Vuolanto.
In the scientific, pre-clinical testing stage, we have seen that it protects neurons, it decreases the alpha synuclein aggregates and also removes neuro inflammation
Antti Vuolanto, CEO of Herantis Pharma Plc
Earlier studies on mice found that HER-096 had a positive effect on relieving motor symptoms too. “We saw robustly exactly what we wanted to see in the pre-clinical setting, so that’s very clear evidence,” says Vuolanto. “But, of course, the pre-clinical data and transferring that to humans, to patients, that’s always the critical part of developing a drug.”
If trials of HER-096 continue to proceed successfully, Vuolanto outlines Herantis Pharma’s vision for its future.
“What we hope is that once patients have been diagnosed, they could start using HER-096 and that would stabilise the disease at that stage, so there would be no further degradation of the neurons, and at that stage the symptoms should be quite well managed. And we have also seen in animal studies that it has a symptomatic effect, so it’s also possible that HER-096 when used to treat people long term might also alleviate the symptoms.
“But most likely it may also be possible to combine HER-096 and, let’s say, levodopa, so one is treating the symptoms, and one is preventing the symptoms from getting worse. That kind of combination therapy could be one of the potential usages going forward.”
The next step is to set up a Phase 1b clinical trial to start next year, which will test the safety and tolerability of multiple doses of HER-096 on people with early-stage Parkinson’s. Subject to the results of this trial, a Phase 2 clinical trial and long-term studies would then be carried out to test whether HER-096 can have a therapeutic effect on people with Parkinson’s.
- Watch the Herantis Pharma Plc Phase 1a topline results webinar about their HER-096 trial
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