The agenda for the 2017 Pain & Migraine Therapeutics Summit has not yet been finalized.
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Development of Innovative DNA Medicine for Diabetic Neuropathy: Scientific Basis and Results from Phase I and II Studies in the US
A new concept medicine has been developed for diabetic neuropathy, based on naked plasmid DNA (VM202) engineered to express two isoforms of human hepatocyte growth factor. In Phase I and II studies done for painful diabetic peripheral neuropathy (DPN), i.m. injection of VM202 demonstrated excellent safety profile and highly effective pain relieving effects for a long period of time, with a suggestion of recovery of sensory function. The scientific basis of using HGF and the data from clinical studies will be presented.
Sunyoung Kim, D.Phil., Founder and Chief Scientific Officer, ViroMed, Professor, Seoul National University
Clinical Progress with Selective Blockers of the Nav1.7 Sodium Channel
It has been well over a decade since channelopathies in the SCN9a gene (which encodes for the Nav1.7 channel), were first implicated in human pain states. Many pharmaceutical companies have sought selective molecules targeting the Nav1.7 channel, as potential new drugs in the treatment of chronic pain. As we move towards larger phase 2 and pivotal phase 3 trials, this talk will review the clinical progress that has been made with the first generation of selective Nav1.7 blockers, highlighting the challenges observed, the most successful indications to date and thoughts for future studies.
Simon Tate, Ph.D., Chief Scientific Officer, Convergence, Non-Executive Director, Biogen
Structure Enabled Discovery of Safer Opioid Analgesics
Despite two centuries of medicinal chemistry since the isolation of morphine from the opium poppy, the ideal opioid analgesic devoid of key liabilities like addiction and respiratory depression remains elusive. I will describe our recent efforts to understand the structural and biophysical basis of opioid receptor activation using X-ray crystallography coupled with NMR and fluorescence spectroscopy. Using these insights, we recently embarked on structure-based discovery campaigns to identify novel opioid analgesics. I will discuss the identification and optimization of a selective, Gi biased μOR agonist that elicits analgesia without inducing respiratory depression or a conditioned place preference response and will outline our current efforts to elucidate the structural basis for the remarkable efficacy of such compounds.
Aashish Manglik, MD, Ph.D., Stanford Distinguished Fellow, Department of Molecular and Cellular Physiology, Stanford University School of Medicine
Developing a U.S. Pain Drug for Europe Takes Some Translation
Taking a drug from a U.S. program and developing it for commercialization in Europe often requires some translation to the local European trial, regulatory, and payer environments to be successful. 505(b)2 programs rarely make a successful journey, yet there can be clever shortcuts to a full NDA/MAA and ways to get an adequate price. Know what is needed and prepare for success.
Allen Downs, CLP, Senior Corporate & Business Development Lead, Corporate & Business Development, Mundipharma International Limited
Development Update on Erenumab, an Anti-CGRP Receptor Monoclonal Antibody for Migraine Prevention
Erenumab is a human monoclonal antibody that targets and blocks the calcitonin gene-related peptide (CGRP) receptor. The presentation will focus on Phase 1, 2 and 3 clinical trial results, including results that describe the safety and efficacy of erenumab in prevention of episodic and chronic migraine.
Daniel Mikol, MD, Executive Medical Director, Global Neuroscience Development, Amgen
Potassium Channels as Pain and Migraine Targets: Challenges and Path Forward
This presentation will cover nociceptive pathways and potassium channels and pain signaling with emphasis on Voltage-gated potassium channels and Two pore domain channels drug discovery
Narender Gavva, Ph.D., Scientific Director, Amgen
Abuse-Deterrent Opioid Development: An Evolving Regulatory Landscape
In this presentation, Dr. Dayno will:
- Review the FDA Guidance on Abuse-Deterrent Opioid Development and Labeling
- Discuss the challenges in conducting these programs and importance of working with the FDA during development
- Provide recent history of AD product approvals and concept of incremental improvement
- Discuss the FDA Opioid Action Plan, its goal to balance access to effective analgesics while reducing opioid misuse and abuse in our communities, and how AD opioids serve as a preventive approach in helping to achieve this goal
Jeffrey Dayno, MD, Chief Medical Officer, Egalet
Opioid Sparing Endpoints: Trial Design, Clinical Relevance and Label Claims
Many analgesic drug developers seek an opioid sparing claim for their drug label. However, the regulatory criteria for this claim can be complex, and the FDA requires extensive experimental backup to allow an opioid sparing label. Additionally, there are multiple tiers of opioid sparing label that can be awarded. Dr. Neil Singla is Chief Scientific Officer of Lotus Clinical Research, a specialty analgesic CRO and research site that has performed over 100 analgesic clinical trials and helped guide several analgesic agents through FDA approval.
In this talk Dr. Singla will outline:
- The criteria required for each type of opioid sparing label
- Examples of recently approved drugs for which opioid sparing claims were sought, both successfully and not
- A review of labels, protocol designs and endpoints, and resulting publications for these drugs
- The types of opioid sparing label the FDA awards
Neil Singla, MD, Chief Scientific Officer, Lotus Clinical Research
The presentation will review the efficacy and safety of a single intra-articular injection of CNTX-4975 over a 24 week double-blind trial. Efficacy brings a patient group with severe pain, on average, to mile pain, on average, at the 12 week primary, with statistical separation in pain at 1 week and durability out to 6 months.
Dr. Nemenov and his team at LasMed LLC have developed a method that allows for selective activation of silent C mechano-insensitive (CMi) fibers and -A delta fibers. An assessment of CMi fibers underlie spontaneous pain and A-delta fibers denervation in patients with all peripheral neuropathy types. DLss-QST is an easy to use, and safe in both animals and humans. Because of these capacities, DLss can be instrumental in determining efficacy of novel therapeutics for neuropathic pain, and uniquely, spontaneous neuropathic pain.
Peripheral sensory neurons have the capacity to produce acetylcholine (ACh) and express muscarinic type 1 ACh receptors (M1R). In vitro studies using adult sensory neurons employ an autocrine cholinergic loop that constrains neurite outgrowth via the M1R and suppression of mitochondrial function. Disruption of this endogenous cholinergic constraint mechanism by M1R antagonists or receptor deletion enhanced respiration and neurite outgrowth. Systemic or topical delivery of specific, selective or non-selective M1R antagonists to rodent models of diabetic neuropathy attenuated biochemical markers of mitochondrial dysfunction and prevented and reversed assorted structural, functional and behavioral indices of degenerative peripheral neuropathy and neuropathic pain without impacting severity of diabetes. Treatment with M1R antagonists was also effective in animal models of peripheral neuropathy caused by chemotherapeutic agents or HIV-associated proteins. These studies identify a novel mechanism that regulates growth of peripheral nerves and reveal novel therapeutic targets to protect nerve from metabolic stress or promote recovery from injury in diverse peripheral neuropathies. Clinical studies are in progress.