The LUMA study news

 

 

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The outcome of a major Phase 2 clinical trial testing the safety and efficacy of a new class of drug – a LRRK2 inhibitor – has just been announced and the agent was found to have no impact on slowing the progression of symptoms in people with early idiopathic Parkinson’s.

The drug in question is called “BIIB122” and it has been developed by Denali Therapeutics (in partnership with the pharma company Biogen).

While the news is disappointing, we need to wait and see the full results before drawing too many conclusions. In addition, the key word in the sentences above may be “idiopathic”. The real test for this class of agent is probably still to come.

In today’s post, we will discuss the press release, review what a LRRK2 inhibitor is, and consider what this means for our theories of the underlying biology driving Parkinson’s.

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Source: Scientificamerican

When I boarded a plane in London, heading for Phoenix to attend the 2026 World Parkinson’s Congress, all was well in the world.

As I settled in my seat, I checked the news on my phone and found that everything was normal (or at least as normal as it can be in the orange fruit cake world).

When the plane touched down in Phoenix, however, the news was suddenly alive with an announcement from the biotech companies Biogen and Denali Therapeutics.

What did they report?

They said that their LUMA clinical trial had not met its primary endpoint.

What is the LUMA study? And what is a “primary endpoint”?

Continue reading “The LUMA study news”

The luminance of a lighthouse

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LRRK2 inhibition represents one of several biological approaches to slowing the progression of Parkinson’s that is currently being clinically tested.

Leading the charge in the development of LRRK2 inhibitors is a biotech company called Denali Therapeutics (in partnership with Biogen).

Recently, the company provided news on the immediate future clinical development plans for their lead molecule BIIB122.

In today’s post, we will look at what is going to happen next for LRRK2 inhibition.

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Source: Denali

Founded in 2013 by a group of former Genentech executives, San Francisco-based Denali Therapeutics is a biotech company which is focused on developing novel therapies for people suffering from neurodegenerative diseases.

In particular, they have been leading the charge on a new class of drugs for Parkinson’s called LRRK2 inhibitors.

What are LRRK2 inhibitors?

Continue reading “The luminance of a lighthouse”

Denali’s Phase I results

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Leucine-rich repeat kinase 2 (or LRRK2) is a large, multi function protein that is associated with Parkinson’s. People with genetic variations in the region of DNA that provides the instructions for making LRRK2 protein have a higher risk of developing the condition.

In many cases of Parkinson’s, LRRK2 can become hyperactive. Researchers and biotech companies have been striving to identify drug-like molecules that can dampen down this hyperactivity in the hope of slowing down the progression of Parkinson’s.

One of the leading biotech firms in this area of research is Denali Therapeutics, and recently the company has provided some updates on their progress.

In today’s post, we will discuss what LRRK2 is, we will look at what Denali have achieved thus far, and we will review what the company has recently announced.

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Source: Denali

A presentation was given at the UBS 2021 Global Healthcare Virtual Conference this week by representatives from Denali Therapeutics.

The slide deck (which can be found here on the company’s website) touched on multiple lines of active research for the company, including their active clinical trial programs:

  • DNL310 (ETV:iduronate-2-sulfatase (IDS) for Hunter syndrome), which has expanded testing in Phase 1/2 based on positive interim data
  • DNL343 (EIF2B activator indicated for ALS), which has had positive interim Phase 1 data, and the company is planning a Phase 1b study in ALS (Click here to read a recent SoPD post on EIF2B activation)
  • DNL788 (RIPK1 inhibitor targeted at ALS, Alzheimer’s, & Multiple Sclerosis … I’m really curious, why not PD?!?), which is in ongoing Phase 1 studies in healthy volunteers (in collaboration with Sanofi)
  • DNL758 (aka SAR443122; another RIPK1 inhibitor targeted at inflammation), currently recruiting participants for a Phase 2 study of lupus & in Phase 1 for COVID-19 lung disease (again in collaboration with Sanofi)

Source: Denali

But of particular interest to us here at SoPD HQ were the slides on their LRRK2 inhibitor clinical trial data.

Founded in 2013 by a group of former Genentech executives, San Francisco-based Denali Therapeutics is a biotech company which is focused on developing novel therapies for people suffering from neurodegenerative diseases.

Ex-Genentechers. Source: Medicalstartups

Although they have product development programs for other condition (such as Amyotrophic Lateral Sclerosis and Alzheimer’s disease), Parkinson’s is definitely one of their primary indications of interest.

The company has been leading the charge in the development of LRRK2 inhibitors as a potential therapeutic class for Parkinson’s and they have recently made some big announcements.

What are LRRK2 inhibitors?

Continue reading “Denali’s Phase I results”