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Cerevance, a clinical-stage drug discovery and growth firm centered on mind illnesses, at present introduced the beginning of dosing in a Part I first-in-human scientific trial of CVN424, an oral compound being developed for symptomatic therapy of Parkinson’s illness. This primary-in-class compound modulates a novel protein goal selectively expressed in an necessary class of dopamine-responsive neurons within the striatum. The Part I, double-blind, single- and multiple-ascending dose research being performed in america will assess the protection, tolerability, and pharmacokinetic profile of CVN424 in wholesome topics, in addition to results of meals on the compound’s absorption.

“CVN424 prompts key dopamine-responsive motor pathways however not the neurons implicated in levodopa-induced dyskinesias, the uncontrolled actions that afflict so many Parkinson’s sufferers,” famous David Margolin, Senior VP of Scientific and Translational Medication at Cerevance. “This selectivity could permit CVN424 to match the constructive results of the present normal of care, levodopa, with out its negative effects.”

“The completion of preclinical research, the profitable submitting of the IND, and now the initiation of the first-in-human scientific trial for CVN424 are important milestones for our firm,” mentioned Mark Carlton, Ph.D., Chief Scientific Officer of Cerevance. “This compound exemplifies Cerevance’s method of figuring out and modulating therapeutic targets which are selectively expressed in disrupted circuits or susceptible neuronal and glial populations in central nervous system illnesses.”

September 25, 2018

Seventy-eight studies were included in the analysis

A review of several second-generation disease-modifying therapies (DMTs) found that these agents were not associated with an increased risk of psychiatric side effects in patients with multiple sclerosis (MS). The findings were published online in the journal Multiple Sclerosis and Related Disorders.

To investigate the link between second-generation DMTs and adverse psychiatric effects, the authors searched various databases for studies involving MS patients treated with one of the following DMTs: alemtuzumab, dimethyl fumarate (DMF), fingolimod, natalizumab, or teriflunomide. The primary outcome measure of the study was the frequency of any adverse psychiatric effect observed during treatment with one of these agents. The authors also investigated the effect of treatment on depression and anxiety symptoms as a secondary outcome.

Seventy-eight studies were included in the analysis (48 randomized controlled trials, 28 observational studies, and 2 case reports), most of which involved natalizumab (N=30) or fingolimod (N=29). Among these studies, depression was found to be the most common adverse psychiatric effect reported, followed by anxiety. However, none of the agents evaluated were associated with a statistically significant increased risk for these effects. Of the 18 studies that assessed changes in depression or anxiety following treatment with fingolimod, natalizumab or DMF, only fingolimod was tied to statistically significant improvement in depressive symptoms.

“Fingolimod may have a slight beneficial effect on symptoms of depression,” the authors concluded, “This may reflect either a positive direct effect (eg, immune modulation) or an indirect effect arising due to a positive impact on disease activity or course.”

For more information visit MSARD-journal.com.

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Lumos Pharma, Inc., a scientific stage biopharmaceutical firm targeted on growth and commercialization of therapeutics for uncommon and uncared for ailments, right this moment introduced that it has acquired the license for LUM-201, an investigational orally administered small molecule that promotes secretion of development hormone from the pituitary gland, from Ammonett Pharma LLC. Lumos plans to provoke a Section IIb trial in 2019 in sufferers with Pediatric Development Hormone Deficiency (PGHD) to match a number of doses of LUM-201 to every day injections of recombinant human development hormone, which is the present normal of care. Rick Hawkins, CEO of Lumos Pharma, commented, “The Lumos traders and the complete Lumos staff are extraordinarily excited for the chance to quickly advance this oral candidate for PGHD sufferers. Many sufferers will probably admire a substitute for injections.” Michael Thorner, MB, BS, DSc, a number one endocrinologist primarily based on the College of Virginia and adviser to Lumos who has lengthy been concerned with this system whereas an govt at Ammonett Pharma, commented, “Lumos is the right firm to advance this remedy to approval. It has glorious uncommon illness drug growth experience and sources. I stay up for working with the staff on the product’s growth and commercialization.”

September 24, 2018

Soliris reduced the risk of NMOSD relapse by 94.2% compared with placebo

Treatment with Soliris (eculizumab; Alexion) was associated with reduced risk of relapse in patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD), according to topline results from the Phase 3 PREVENT study. NMOSD is a rare, complement-mediated central nervous system disorder characterized by relapses that result in severe disability (blindness, paralysis) and potentially premature death.  

In the PREVENT study, the safety and efficacy of Soliris was compared to placebo in patients with AQP4 auto antibody-positive NMOSD (N=143). The primary endpoint of the trial was time to first on-trial relapse as adjudicated by an independent committee; a key secondary endpoint was adjudicated on-trial annualized relapse rate.

Results showed that Soliris reduced the risk of NMOSD relapse by 94.2% compared with placebo (P <.0001); 97.9% of Soliris-treated patients were relapse-free at 48 weeks compared with 63.2% of patients in the placebo arm. Moreover, compared with placebo, treatment with Soliris reduced the adjudicated on-trial annualized relapse rate by 95.5% (P <.0001). Soliris was generally well-tolerated with a safety profile similar to that seen in previous studies and real-world use.

“The primary goal in treating NMOSD is relapse prevention as each relapse further increases disability, which makes this disease so devastating,” said Michael Levy, MD, PhD, Associate Professor at Johns Hopkins University, and Director of the Neuromyelitis Optica Clinic in Baltimore, MD. “The substantial effect of Soliris seen in this groundbreaking randomized, controlled study in NMOSD could potentially become a turning point for patients and their families who live in constant fear of relapse.”

Soliris, a complement inhibitor, is currently approved by the Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and for adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor (AchR) antibody positive.  

“These results far exceeded our expectations, said John Orloff, MD, Executive Vice President and Head of Research & Development at Alexion “Given that patients currently have no approved therapies [for NMOSD], we are moving quickly to discuss these results with regulators and file for approval in the US, EU, and Japan.”

For more information visit Alexion.com.

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