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Herantis to advance Alzheimer’s treatment after FDA meeting 

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Alzheimer's disease drug

Herantis is set to advance the clinical development of its Alzheimer’s therapy following a positive meeting with the US Food and Drug Administration (FDA). 

The company reports it completed a pre-IND meeting with the FDA to discuss the planned clinical development of HER-096, a first-in-class small peptide being developed to treat Alzheimer’s disease. 

Herantis claims the regulatory body confirmed it would be in a position to activate US clinical sites should an Investigational New Drug (IND) application be submitted. The FDA also considered the Phase IIa trial design appropriate for the current stage of development. 

The Phase IIa study is designed to evaluate the efficacy, safety and tolerability of HER-096 in patients with early-stage Parkinson’s disease and is expected to provide the first evidence of its potential to deliver meaningful clinical benefit in patients.  

The Phase IIa trial is expected to enrol approximately 100 newly diagnosed Parkinson’s disease patients who are not receiving symptomatic medication across multiple sites in Europe. Patients will receive twice-weekly subcutaneous dosing of HER-096 or placebo for six months, followed by a six-month open-label extension. 

“The successful outcome of our FDA meeting is an important milestone as we advance HER-096 towards Phase II development,” said Antti Vuolanto, CEO of Herantis Pharma. 

“Together with our positive Phase Ib data, encouraging biomarker findings and Horizon Europe grant support, the FDA  feedback strengthens our confidence in the program and our development strategy.  

“With the study design now finalised and our CRO partner selected, we have taken a significant step towards initiating the Phase IIa proof-of-concept efficacy study. We look forward to initiating the study and generating data that will further evaluate HER-096’s potential as a disease-modifying treatment for Parkinson’s disease.” 

 

The post Herantis to advance Alzheimer’s treatment after FDA meeting  appeared first on Drug Discovery World (DDW).

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New webinar: Tackling drug discovery challenges in cancer research

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Cancer cells

Hosted by Drug Discovery World and supported by Sartorius and BioIVT, this webinar will explore the opportunities and challenges that exist within cancer research drug discovery and development.

You will hear from Dr Sudha Rao, Chief Scientific Officer of Kazia Therapeutics, Karol Budzik, PhD, Business Development Associate at Vyriad Therapeutics and Lars van der Veen, Chief Scientific Officer at iOnctura.

Presentations will cover how cancer treatments have shifted towards reprogramming the biology driving tumour growth, immune escape and treatment resistance, the trajectory that in vivo CAR-T treatments are taking, and how challenging tumours burdened by stroma and immune-mediated resistance can be tackled.

Q&A with the speakers follows the presentations.

Register for free now.

The post New webinar: Tackling drug discovery challenges in cancer research appeared first on Drug Discovery World (DDW).

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Psilocybin proves promising in neuropathic pain mouse study

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Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.

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New Spectrometry Technique Could Aid Formulation Development

New Spectrometry Technique Could Aid Formulation Development

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A new technique combining two forms of spectrometry could help biopharmaceutical companies improve their choice of formulation buffer for antibody manufacturing by revealing how molecular forms and three-dimensional shapes of complex biologics respond to their environment. That’s the view of Christian Bleiholder, PhD, a professor at Florida State University who helped develop the technique.

According to Bleiholder, what happens structurally when a complex biological molecule, such as an antibody or viral spike protein, binds to its target is currently poorly understood.

“This is where [this approach] can help with the bioprocessing and formulation,” he says, as structural changes “can affect the lifespan [of the product] and lead to issues, such as aggregation.”

Because antibodies are complex, existing techniques tend to be powerful at different levels of complexity, he explains. Mass spectrometry is particularly powerful for distinguishing molecular composition, while structural approaches such as X-ray crystallography and cryo-electron microscopy can provide high-resolution structural information.

The challenge is understanding the link between these things within a heterogeneous sample, he says.

To overcome this, Bleiholder and his team worked with Bruker Daltonics to develop Tandem-Trapped Ion Mobility Spectrometry (Tandem-TIMS). This combines tandem ion mobility spectrometry with tandem mass spectrometry to disentangle three overlapping layers of molecular complexity: molecular form, three-dimensional shape, and binding or assembly state, he says.

He explains that, if the proteins have different structures, they can be characterized with tandem ion mobility spectrometry, and then mass spectrometry can be used to look at their molecular forms and binding states.

Going forward, Bleiholder hopes the technique can be used for formulation development but also earlier, during drug discovery of new products, such as multi-specific antibodies, to determine which molecular states are important and how those change when a biologic engages its target. He also plans to look at automating the technique.

Bleiholder spoke about using Tandem-TIMS at the Bioprocessing Summit in Boston earlier this year.

The post New Spectrometry Technique Could Aid Formulation Development appeared first on GEN – Genetic Engineering and Biotechnology News.

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