Denali Therapeutics & Biogen Announce Initiation Of Phase 2b Study Of Lrrk2 Inhibitor In Parkinsons Disease
Denali Therapeutics Inc. and Biogen Inc. recently announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 , as compared to placebo in approximately 640 participants with early-stage Parkinsons disease.
LUMA is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of BIIB122 in people with early stage Parkinsons disease between the ages of 30 and 80. The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinsons Disease Rating Scale parts II and III combined score over the treatment period. Participants will be randomized to receive oral BIIB122 or placebo once daily.
More than 10 million people worldwide are affected by Parkinsons disease, and there is a significant medical need for therapies to slow or stop the progression of this devastating neurodegenerative disease, said Carole Ho, MD, Chief Medical Officer at Denali. Initiation of the LUMA study marks an important milestone in the development of BIIB122 as a potentially first-in-class oral LRRK2 therapy for Parkinsons disease. We look forward to continuing our collaboration with Biogen and the Parkinsons community in our unified goal to develop BIIB122 as a potential treatment option for people and families living with Parkinsons disease.
Further information about LUMA can be accessed at clinicaltrials.gov.
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Biogen Denali Begin Late
Part of a $1 billion alliance the companies formed in 2020, the drug will be tested in a large study of patients who test positive for mutations in a gene called LRRK2.
Biogen and Denali Therapeutics said Monday that a late-stage study evaluating their experimental drug for Parkinsons disease has started to dose patients, marking the latest milestone in a research collaboration the companies inked two years ago.
The study aims to enroll about 400 participants who test positive for what research indicates is one of the most common genetic drivers of Parkinsons: mutations in a gene called LRRK2. The drug Biogen and Denali are co-developing, now named BIIB122, is meant to stifle LRRK2, and is being tested against a placebo to see if it can significantly slow the worsening of symptoms in patients with early-stage Parkinsons.
Biogens head of neurodegeneration development, Samantha Budd Haeberlein, said in a statement that the study, dubbed LIGHTHOUSE, is the largest ever focused on Parkinsons patients whose disease is caused by LRKK2 mutations. Results from the trial are expected in early 2031, according to a federal clinical trials database.
Biogen and Denali are also conducting a mid-stage trial of BIIB122 in Parkinsons patients who dont have these mutations. That trial is trying to enroll around 640 patients, and should produce results in 2025.
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Eisai And Biogen Announce Positive Phase 3 Results For Lecanemab
Contributed by Joshua Grill, PhD
Today, Eisai and Biogen announced that the topline results of their Phase 3 trial, known as CLARITY, were positive.
CLARITY was a placebo-controlled double-blind study of the monoclonal antibody against the amyloid beta protein lecanemab in patients with Mild Cognitive Impairment or mild dementia due to Alzheimers disease. Lecanemab has been shown previously to reduce amyloid burden in the brain of patients with symptomatic Alzheimers disease. According to todays press release, lecanemab was effective in slowing decline measured with the Clinical Dementia Rating Scale , compared to placebo. This scale has been suggested by the US FDA as a potentially sufficient global outcome measure to demonstrate the clinical benefit of a new treatment for Alzheimers disease and the new data could position the drug to be approved in 2023. The results have been announced, but not yet presented or peer reviewed. While some judgment must be reserved, the announcement is exciting. According to the press release, the benefit was observed not only on the primary global outcome , but also on all secondary outcomes, including specific measures of cognition and function .
Biogen Alectos Collaborate To Develop Parkinsons Disease Treatment
The deal will combine Alectos therapeutics expertise with Biogens development capabilities in movement disorders.
Biogen has entered into a license and collaboration agreement with Alectos Therapeutics to develop and commercialise AL01811 for the treatment of Parkinsons Disease .
AL01811 is a new preclinical selective GBA2 inhibitor, which has first-in-class potential to be an oral disease modifying treatment for PD patients.
The deal will combine Alectos small-molecule therapeutics expertise with Biogens development expertise in movement disorders.
Under the deal, Alectos will receive a $15m upfront payment and is eligible for potential development payments of up to $77.5m and commercial milestone payments of $630m.
Additionally, Alectos will receive tiered royalties in the high-single-digits to mid-teens.
Alectos Therapeutics president and CEO Ernest McEachern said: By combining Alectos expertise in small-molecule therapeutics with Biogens global development expertise in Parkinsons disease, we believe we will be well-positioned to help bring AL01811 to patients in need.
Were also energised by the opportunity to tap into Biogens commercial acumen in order to advance the standard of care in Parkinsons disease and movement disorders more broadly.
Both the companies will also work on preclinical activities for AL01811.
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About The Clinical Trial Process
Biogen is conducting numerous clinical trials in neurologic and immunologic diseases to evaluate the efficacy and safety of potential therapies.
- View our current pipeline to learn more about clinical trials for specific conditions
- See detailed information on currently enrolling clinical trials for Biogen investigational and marketed therapies on clinicaltrials.gov
- Biogen Trial Link: Learn more about clinical trials, why they are important, what they involve, and view our currently enrolling U.S. trials for Alzheimer’s disease, multiple sclerosis, and Parkinson’s disease
What Is The Role Of A Caregiver In A Parkinsons Disease Clinical Trial
Someone who cares for you, for example, a partner, sibling, other family member, close friend, or professional caregiver, may help you during the clinical trial. This may be to help you get to and from your appointments and support you throughout the trial. Or, they might be asked to help monitor any changes in your condition and report them to us. Visit our section on caregivers for more information about their role.
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Biogen Denali Begin Phase Iib Trial Of Parkinsons Disease Therapy
The trial will analyse the safety and efficacy of BIIB122 in nearly 640 Parkinsons patients aged between 30 and 80 years.
Biogen and Denali Therapeutics have initiated dosing in the international Phase IIb Luma clinical trial of BIIB122 in subjects with early-stage Parkinsons disease.
Denali discovered and developed BIIB122, which is an investigational selective, central nervous system-penetrant small molecule LRRK2 inhibitor.
Hindering LRRK2 is a new approach designed to act on the underlying biological pathway linked to Parkinsons disease.
Currently, the companies are jointly developing and marketing the therapy to potentially treat Parkinsons disease.
The placebo-controlled, multicentre, double-blind, randomised trial will analyse the safety and efficacy of BIIB122 in nearly 640 individuals aged between 30 and 80 years with early-stage Parkinsons disease.
In the trial, subjects will be randomised to receive either a once-a-day dose of oral BIIB122 or a placebo.
The Time to Confirmed Worsening in Movement Disorder Society Unified Parkinsons Disease Rating Scale parts II and III combined score over the treatment duration will be the primary endpoint of the trial.
Denali chief medical officer Carole Ho said: More than ten million people worldwide are affected by Parkinsons disease, and there is a significant medical need for therapies to slow or stop the progression of this devastating neurodegenerative disease.
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Biogen Ditches Parkinsons Drug After Phase Ii Study Fails To Show Benefit
Biogen announced Wednesday morning in its annual results and earnings presentationthat its Phase II SPARK study of cinpanemab, a candidate drug for Parkinsons disease, missed its primary and secondary endpoints.
As the therapy did not achieve proof-of-concept and failed to provide benefit in this study, the development of the drug has been discontinued.
The Phase II SPARK study examined the ability of cinpanemab, an anti-alpha synuclein monoclonal antibody, to reduce a measure of impairment and disability compared with placebo. Biogen was hopeful that the drug could successfully compete with Roche and Prothenas syn therapyprasinezumab.
Although we made this determination in February 2021, it was based on conditions that existed as of December 31, 2020, the Biogen statement said. As a result, we recognized an impairment charge of approximately $75.4 million during the fourth quarter of 2020 to reduce the fair value of the related in-process research and development intangible asset to zero.
The company added that it had adjusted the value of its contingent consideration obligation related to the drug, leading to a gain of $51 million in the fourth quarter of last year.
Biogens cinpanemab was previously acquired from Neurimmune in 2016 and entered early-stage trials for Parkinsons disease. In 2018, Biogen presented an overview of the design of the SPARK Phase II study, which at the time is the most advanced program in the companys Parkinsons disease pipeline.
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Biogen Ditches Parkinsons Drug After Trial Flop
Biogen has decided to abandon its development of a treatment for Parkinsons disease after the drug flopped a phase 2 trial.
According to the company, the anti-alpha synuclein monoclonal antibody, cinpanemab, missed its primary and secondary endpoints in a trial comparing it to a placebo. Biogen picked up the treatment from Neurimmune in 2016 and had hopes that it could compete with a synuclein treatment developed by Roche and Prothena.
Biogen announced that it is dropping the development of cinpanemab in an annual results presentation, saying that the company would recognize an impairment charge of approximately $75.4 million during the fourth quarter of 2020.
With the disappointing trial results, more pressure is on Biogen to win approval for its controversial Alzheimers treatment, aducanumab. The FDA was expected to render a verdict on the approval of the drug in March, but recently pushed back the decision date to June 7. If approved, Biogen said it would be ready to launch aducanumab right away. If not approved, Biogen warned that its 2021 forecast would suffer given that a significant portion of its manufacturing capacity has already been allocated to the drug.
Biogen Denali Begin Mid
Biogen Inc. BIIB and its collaboration partner Denali Therapeutics Inc. DNLI announced that they have initiated dosing in a phase IIb study LUMA evaluating their pipeline candidate, BIIB122 .
The LUMA study will compare the efficacy and safety of BIIB122 with a placebo in patients with early-stage Parkinsons disease aged between 30 and 80 years. The primary endpoint of this mid-stage study is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale parts II and III combined score over the treatment period. Per the International Parkinson and Movement Disorder Society, the scale measures various aspects of Parkinsons disease, including non-motor and motor experiences of daily living and motor complications, and characterizes the extent and burden of the disease.
Biogen and Denalis BIIB122 targets a novel gene, LRRK2, that has the potential to impact the underlying biology and slow the progression of Parkinsons disease. The companies are developing an oral formulation of this LRRK2-inhibiting therapy for Parkinsons disease.
Biogen and Denali entered into a collaboration in 2020 to design a rigorous development program to evaluate BIIB122 in patients with and without LRRK2 mutations. As part of their collaboration, Biogen and Denali are planning to start a phase III study LIGHTHOUSE to evaluate BIIB122 in individuals with Parkinsons disease with LRRK2 pathogenic variants later this year.
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Denali Therapeutics And Biogen Announce Initiation Of Phase 2b Study Of Lrrk2 Inhibitor In Parkinsons Disease
- BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinsons disease
- Phase 2b LUMA to enroll approximately 640 participants with early-stage Parkinsons disease most advanced clinical study of a LRRK2 inhibitor
SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass., May 31, 2022 — Denali Therapeutics Inc. , and Biogen Inc. today announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 , as compared to placebo in approximately 640 participants with early-stage Parkinsons disease.
LUMA is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of BIIB122 in people with early-stage Parkinsons disease between the ages of 30 and 80. The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale parts II and III combined score over the treatment period. Participants will be randomized to receive oral BIIB122 or placebo once daily.
Further information about LUMA can be accessed at clinicaltrials.gov.
BIIB122 is a selective, central nervous system-penetrant small molecule inhibitor of LRRK2 that is hypothesized to improve lysosomal dysfunction. BIIB122 is an investigational drug that is not approved by any regulatory authority, and its safety and efficacy have not been established.
New Clinical Trials Targeting The Lrrk2 Gene
LRRK2 is a protein that becomes hyperactive in some people with Parkinsons, and this increased level of activity is believed to be involved in the progression of their Parkinsons. Now, two biotech companies will conduct two clinical trials to test their LRRK2 inhibitor drug to reduce this hyperactivity, to try to slow or stop the progression of Parkinsons.
Approximately 1% of people with Parkinsons have a small mutation in their DNA in a region called the LRRK2 gene. This gene provides the instructions for making a protein called Leucine Rich Repeat Kinase 2 . Normally, the LRRK2 protein plays important roles in the biology of cells, but in people with this LRRK2 gene variant, the LRRK2 protein becomes hyperactive. This overactive version of the protein is associated with an increased risk of developing Parkinsons, and it is believed to play a role in the progression of the symptoms of the condition.
Scientists have been searching for medicines that will reduce the activity of the LRRK2 protein in the hope that this might provide a means of slowing down the progression of Parkinsons in people with hyperactive forms of LRRK2. Biotech company Denali Therapeutics, has been leading the development in this field of research. Now, they have joined forces with another biotech company, Biogen, to progress two large clinical trials to evaluate their LRRK2 inhibitor, BIIB122.
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Biogen Bolsters Pipeline Again With Alectos Deal
Biogen has added a preclinical-stage drug candidate for Parkinsons disease via a $722.5 million licensing agreement with Alectos Therapeutic, as it continues to rebuild a pipeline behind its side-lined Alzheimers therapy Aduhelm.
The deal includes a $15 million upfront payment that gives Biogen global rights to selective GBA2 inhibitor AL01811, which it says has the potential to become a first-in-class oral therapy for Parkinsons that could strike at the pathological mechanisms that underlie the neurodegenerative disease.
In a statement, Biogen said that AL01811 is designed to target dysfunction in lysosomes organelles which play a vital role in cell function by breaking down excess or worn-out cell parts and can be impaired in Parkinsons.
Alectos drug helps to maintain the acid pH level in lysosomes required for their function in the hope of restoring their activity and hypothetically at least slow the progression of Parkinsons in patients with and without known genetic risks.
Along with the upfront payment, Biogen has pledged up to $77.5 million in potential development payments, as well as up to $630M in commercial milestones if AL01811 makes it to market and performs as hoped.
People who have Parkinsons experience numerous symptoms, including tremors, slow movement, muscle stiffness and impaired balance. As these symptoms become progressively worse, patients have difficulty walking, talking or completing other simple tasks.
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While the role of LRRK2 is not fully clear, a body of research suggests that its aberrant activation affects transit within cells, particularly the activity of lysosomes, subcellular compartments responsible for breaking down and recycling excess material and damaged cell parts. Abnormalities in lysosome activity may contribute to neurodegeneration.
BIIB122/DNL151, co-developed by Denali and Biogen, is a selective small molecule designed to cross the blood-brain barrier and block LRRK2 activity, specifically in the nervous system. The companies believe that doing so could restore lysosomal function and potentially slow Parkinsons progression. The blood-brain barrier, often called the BBB, is a highly selective membrane that shields the central nervous system from potential insults like viruses carried in the bloodstream.
The planned global trials the Phase 3 LIGHTHOUSE and the Phase 2b LUMA study will evaluate BIIB122/DNL151 in patients with and without LRRK2 mutations.
LIGHTHOUSE aims to enroll about 400 Parkinsons patients with LRRK2 mutations to test BIIB122/DNL151s effectiveness, with treatment running for at least 96 weeks . The LUMA Phase 2b study will recruit about 640 patients without LRRK2 mutations. This trial, designed to potentially support a request for BIIB122s regulatory approval, will dose selected participants for at least 48 weeks .
ROPAD, through tests given over two years, aims to identify 1,500 patients with LRRK2 mutations.
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