NeuroPerspective capsules

The March/April 2018 issue of NeuroPerspective has been released, featuring in-depth reviews of Depression and PTSD.

Depression represents a patient population whose treatment falls far short of the bucolic illustrations suggested by DTC advertising for the current crop of pharmacotherapies. The majority of patients do not find adequate relief from their first trial, and 25% do not find sufficient benefit from any of the antidepressants they try. Aversive side effects, including weight gain and sexual dysfunction, form a significant barrier to utilization, and the long delay to relief is counter-therapeutic. New drugs seem to offer the prospect of near-immediate depression relief, led by the much-publicized impact of IV ketamine. Prominent RAAD programs come from JNJ (whose Phase III results have been delayed without explanation); Allergan; the surprising SAGE Therapeutics program; and potentially, Perception NeuroScience, to name but four. Suicide risk represents a growing societal problem, as is Treatment-Resistant Depression, where nothing seems to work. SAGE has made significant progress with Post-Partum Depression, with Marinus Pharmaceuticals hoping to follow suit. Other antidepressant programs reviewed include those from Alkermes, Blackthorn Therapeutics, NeuralStem, Navitor.

PTSD (Post-Traumatic Stress Disorder) has risen in profile as a result of both natural (tsunamis, firestorms) and human-made (combat, mass shootings) disasters, and the more pervasive but lower profile scourge of sexual/physical/emotional abuse of both children and adults. The pharma industry has generally taken a passive approach to PTSD, leaving the funding of research to the DoD and VA in the US, but small companies are beginning to explore this undertreated and very large-scale domain: Aptinyx, Azevan, Marinus, Rodin, SpringWorks, Tonix Pharma. Interventions can be focused upon attenuating the limbic  system hyperactivation of PTSD and/or accentuating the cognitive rewriting of traumatic memory.

The March/April issue also discusses Pfizer’s CNS retreat; Axovant’s failure; the ‘revision’ of FDA guidelines for Alzheimer’s; and the several high-quality, pioneering partnerships signed in recent months: Takeda with both Denali and Wave Life Sciences, AbbVie with Voyager Therapeutics.

The January/February issue of NeuroPerspective has been released, and as is the annual tradition, it reviews 2017 and previews 2018. Over 80 companies have capsule summaries of important events and anticipations, including Acorda, Adamas, Alkahest, AgeneBio, Allergan, AveXis, Biogen, Biohaven, Blackthorn, Denali, Genentech, JNJ, Lilly, Lundbeck, Marinus,  Minerva, Neuren, Neurocrine Biosciences, Newron, Perception, Pfizer, Roche, SAGE, Sunovion, Teva, Trevena, United Neuroscience, Voyager Therapeutics, Wave Life Sciences, Xenon, Zogenix, and fifty more.

Highlights and Lowlights from 2017 are assessed, with particular consideration of Scott Gottlieb’s tenure at the FDA; new GABAergic programs for depression (e.g. SAGE and Marinus); Roche‘s savvy strategy with Ocrevus; the impending revolution in migraine treatment as the CGRP system comes into its own as a target (Amgen/Novartis, Teva, Lilly, Alder, Allergan, Biohaven); the Opioid Epidemic and the slow-to-emerge shift in regulatory tactics to address it; the Gut-Brain Microbiome; Progress in BBB delivery technologies (e.g. BiOasis, Armagen, Roche/Genentech, Denali). Trends in neuroscience funding and partnering are examined, as is the sad debacle that was Dart Neuroscience; Brent Saunders (Allergan) and his oscillation from paragon to parody; and our consideration of whether aducanumab is going to be ‘déja vu all over again.’

This issue also includes a guest article from Joel Sanders PhD (Defined Health/Cello Health), who takes his lengthy experience in assessing the field of immunooncology and turns it to CNS, in ‘The Rise of Neuroimmunology.’ The Company Spotlight covers NMDA specialist Aptinyx.

NI Research has released the November/December issue of NeuroPerspective, which features our comprehensive reviews for two major neurodegenerative disorders: Parkinson’s and ALS. These reviews include a consideration of the current thinking around pathophysiology and therapeutic targets, including the protein aggregates considered to be associated with these disorders: Alpha-synuclein, TDP-43, and c9orf72.  Neuroinflammation, GBA as a target, the gut-brain microbiome, and other mechanisms of current interest are included. Progress in the delineation of biomarkers and models is discussed.

The Parkinson’s review includes 140+ programs, including PD development programs from AbbVie, AC Immune, Affiris, Allergan/Lysosomal, Biogen, Cantabio,  Biogen, Denali, Genentech, ImStar, Intra-Cellular, JNJ, Lundbeck, Minerva, Neurocrine,  Prothena/Roche, and Voyager. The ALS review includes 75+ programs, including those from AB Science, Aquinnah Pharma, Arrakis, Astellas/Cytokinetics, Biogen/Ionis, Califia, Denali/Incro, Gladstone Institute, ImStar, Iron Horse Therapeutics, Locana, Neuraltus, Neurimmune, Voyager Therapeutics, and Wave Life Sciences. 

Cantabio Pharma is the focus of the Company Review. Sidebars include a more detailed look at the failure of the SAGE brexanolone trial in SRSE; ethical issues around Avanir’s marketing of Nuedexta; and Axovant’s failure in Alzheimer’s. 65 pages.

NI Research is the leading publisher of independent research on the neurotherapeutics industry, and has developed an unmatched information base regarding both publicly and privately held CNS companies. The November/December issue’s review of PD and ALS is the continuation of a two-issue sequence on neurodegeneration, with the September/October 2017 issue having comprehensively covered Alzheimer’s.

NeuroPerspective is the authoritative, independent, monthly review of the neurotherapeutics area, providing critical analyses of therapeutics-in-development.  A one-year (1-5 user) subscription to NeuroPerspective is $2600. A 6-10 user subscription is $4630. Other customized userbase and  startup pricing options are available. The Parkinson’s/ALS  review issue of NeuroPerspective is available as a single-issue purchase for $600.

NI Research has also released the 2017-18 edition of NeuroLicensing, which comprehensively reviews current licensing trends in the CNS area, and assesses large and midsize pharma companies in terms of their licensing agendas and performance.

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The September/October issue of NeuroPerspective features our annual, epic, and comprehensive review of the Alzheimer’s space, including a review of the current thinking around pathophysiology and therapeutic targets:An updated assessment on the roles of amyloid, tau, neuroinflammation, and other targets is included. The subtitle for the review is  ‘Reset, Reboot,Recalibrate’, because the traditional modus operandi for the Industry in its approach to AD has produced little beyond a series of dispiriting failures and mediocre demi-signals.  

Among the 150+ programs are assessed are those from: AbbVie, AB Science, AC Immune, AgeneBio, Allergan, Alkahest, Anavex, Asceneuron, AstraZeneca, Axon-Neuroscience, Axovant, Biogen, Cognition Therapeutics, Cortexyme, Denali, Eisai, E-Scape, Genentech, Intra-Cellular, JNJ, Karuna, Lilly, Lundbeck, Merck, Novartis, Oryzon, Pfizer, Prana, Probiodrug, Proclara, ProMIS, Roce, Takeda, TauRx, Tetra Drug Discovery, United Neuroscience, and Voyager. Alkahest is the focus of the Company Review, sidebars include coverage of the current state of the AD Biomarker art and a consideration of the POC timelines for major AD programs.

The Sept/Oct issue also includes a full review of ADHD, including the search for nonstimulant options that might approach the efficacy of the psychostimulants. Programs from Aevi, Alcobra, NLS Pharma, Otsuka/Neurovance, Sunovion, and Supernus are among those assessed in the review.

75 pages.

The July/August issue of NeuroPerspective features our midyear appraisal of the CNS therapeutics sector, including capsule reviews of more than 100 neuro-oriented companies. It also includes a comprehensive review of Spinal Cord Injury, for which a confluence of regenerative pharmacotherapy and sophisticated neurorehabilitation techniques appears poised to offer the prospect of significant functional improvement in the lives of individuals with SCI. In that vein, the Company Review is of BioAxone, which is approaching the 2018 completion of a Phase IIb in SCI, in conjunction with its partner, Vertex Pharmaceuticals. Sidebars include commentary on the potential importance of huntingtin isoforms in the treatment of HD, and some ‘too good to be true’ claims for the use of suramin in Autism. 48 pages.

The May/June issue of NeuroPerspective for 2017 has been released, offering detailed reviews of two therapeutic areas, as well as coverage and commentary regarding significant developments in the CNS therapeutics space.

The first therapeutic sector review covers Schizophrenia, the most devastating of all the psychiatric disorders, one which reflects the awkward melding of multiple schizophreniform disorders with very divergent symptom patterns. Affecting about 1% of the population, schizophrenia’s genetic vulnerabilities are complex and contribute to schizophrenia’s etiological confluence of genetic flaws, prenatal/perinatal environmental factors, and later anomalies in the formation and ‘editing’ of synaptic networks. While still speculative, it does appear that at its root, schizophrenia arises from neurodevelopmental failure exacerbated by the degenerative impact of aberrant adolescent synaptic ‘pruning.’ Network deficits account for the neural dyscontrol that sets the stage for hallucinations/delusions, and for the impoverishment of cognitive capabilities and motivation. Current therapeutics are solely aimed at the so-called positive symptoms of schizophrenia, to this point no one has had success developing treatments for the cognitive and negative symptoms that take such a functional toll, even when the more florid symptoms of schizophrenia are relatively controlled. Some of the companies whose programs are discussed in the review include: Annexon Biosciences, Allergan, SAGE Therapeutics, Takeda, Merck/Bionomica, Acadia, Promentis, Newron, Intra-Cellular Therapies, Karuna Pharmaceuticals, and Sunovion. With Tardive Dyskinesia one of the horrific legacies of an earlier era of antipsychotic treatment, the issue also assesses the two new entrants for the treatment of TD, from Neurocrine Biosciences and Teva.

The second therapeutic sector review covers Epilepsy, which has seen the development of a novel mechanistic approach (orexin antagonism), despite the  plethora of relatively effective but imperfect GABAergic sedative-hypnotics already available. Those drugs have a number of shortcomings, but create a genericized environment that constitutes a significant commercial challenge. This has been tackled by Merck‘s suvorexant/Belsomra, handicapped by FDA-imposed dosing recommendations that recommended a subclinical dose, ensuring that many prescribers and patients would be initially dissatisfied. Merck has not broken out its sales figures, which is a sure sign that they lag expectations.  The other companies whose programs are discussed in this review include: Eisai/Purdue Pharma, Minerva Neurosciences/JNJ, Ferrer/Ergomed, Intec Pharma, and the Actelion spin-out company.

The May/June issue also includes discussion of recent clinical findings from AveXis, Neuren, Catalyst, and Allergan, as well as commentary on the dismantling of BMS’ CNS portfolio and the emergence of BioHaven; and the activist investor putsch at Depomed. Company Spotlight Reviews are included for BioHaven Pharmaceuticals and Karuna Pharmaceuticals.

NI Research is the leading publisher of independent research on the neurotherapeutics industry, and has developed an unmatched information base regarding both publicly and privately held CNS companies. NeuroPerspective is the authoritative, independent, monthly review of the neurotherapeutics area, providing critical analyses of therapeutics-in-development. 

 A one-year (1-5 user) subscription to NeuroPerspective is $2600.  Special startup, nonprofit, and academic pricing is available. The May/June issue of NeuroPerspective is available as a single-issue purchase for $500.