November 14-15, 2022 | Washington, DC

Identifying and Advancing Novel Pain Drugs Through Clinical Development and Commercialization

2022 Conference Agenda

November 14, 2022 (all times Eastern US time)

8:20 am Chairperson's Opening Remarks
William Schmidt, Ph.D.
, President, Northstar Consulting

8:30 am Solutions to the Patient Centricity Quagmire 
Over recent years, there has been a growing trend towards patient centricity in clinical research and trials. However, the reality is often far from the goal that is patient centricity, resulting in a lose-lose situation for both patient and researchers. Bridging this disconnect from the earliest stages of clinical research and trials by fully implementing a real-world patient centric model is essential to creating patient-centered outcomes. This real-world patient centric model not only impacts those people who live with the chronic diseases being studied, but also results in better outcomes to clinical trials and helps get safe and efficacious life-changing products to market faster.
Shoshana Lipson, Founder & President, Hope in Pain, Executive Director, Migraine Meanderings

9:00 am Multi-Omic Biomarkers of Neuropathic Pain 
Quantifying and predicting the course of neuropathic pain (NP) is a challenge. We currently rely on subjective patient-reported outcomes in clinical practice, augmented by clinical examination and some advanced testing in study settings. Research into the origins of neuroinflammation and its role in the development of NP has identified candidate biomarkers that may enhance our understanding and diagnosis of this condition. We are using a multi-omics approach, supported by machine learning analysis of the data, to identify potentially useful biomarker patterns in the development and course of neuropathic pain in patients receiving chemotherapy for breast cancer.
Joseph Foss, MD, FASA, Chief Medical Officer, NeuroTherapia, Assistant Professor, Case Western University School of Medicine, Staff Anesthesiologist, Cleveland Clinic

9:30 am Developing a Systems Pharmacology Approach to Analgesic Discovery
Traditional analgesic discovery programs are designed to target single proteins, and generate ligands that bind these proteins with high affinity for selective modulation. However, the complex etiology of pain, with multiple active excitability related pathways, suggests a polypharmacology design that simultaneous targets multiple nociceptor selective targets might provide a more efficacious and safe approach to discovering novel analgesics.
Selwyn Jayakar, Ph.D., Instructor in Neurology, Boston Children's Hospital, Harvard Medical School

10:00 am Morning Refreshment & Networking Break

10:30 am Panel Session: New Mechanisms and Models to Enhance Treatment of Headache

Full Description of the session to be announced.
Moderator: Smriti Iyenger, Ph.D., Program Director, Preclinical Screening Platform for Pain (PSPP), Division of Translational Research, NINDS/NIH

Using Human Transcriptomics to Better Understand Headache Mechanisms
RNA sequencing and other omics technologies are beginning to give unprecedented insight into the human peripheral nervous system. The major emphasis of this talk will be on advances in single cell transcriptomes of human nociceptors and how we can use this information to better understand nociceptors that innervate the meninges. A second point of emphasis will be profiling of the human meninges and how this information can be used to form hypotheses about headache mechanisms.
Theodore Price, Ph.D., Ashbel Smith Professor, Director, Center for Advanced Pain Studies, University of Texas at Dallas

Delta Opioid Receptor Agonists for the Treatment of Headache Disorders
Our lab has identified the delta opioid receptor (DOR) as a novel therapeutic target for headache disorders, including migraine and medication overuse headache. We have recently characterized the expression of DOR with pro-migraine neuropeptides, such as CGRP and PACAP; and evaluated the contribution of peripheral vs central DORs in migraine regulation. These studies strengthen the case for development of DOR agonists for headache.
Amynah Pradhan, Ph.D., Director, Center for Clinical Pharmacology, Washington University in St. Louis

Peroxynitrite Contributes to Behavioral and Cellular Responses in Preclinical Migraine Models
Administration of a nitric oxide (NO) donor reliably triggers migraine attacks, but mechanisms by which this occurs are unknown. Reactive nitroxidative species, including NO and peroxynitrite (PN), have been implicated in nociceptive sensitization and neutralizing PN is anti-nociceptive. Using preclinical migraine models, we investigate whether PN contributes to behavioral and cellular responses to an NO donor as well as stress, another widely reported migraine trigger. This presentation will cover findings from these studies that support the targeting of PN as a migraine therapeutic strategy.
Greg Dussor, Ph.D., Professor & Chair, Department of Neuroscience, Eugene McDermott Endowed Professor, University of Texas at Dallas

12:00 pm Luncheon

1:00 pm Discovery of Biomarkers and Biomarker Signatures to Facilitate Successful Pain Therapeutics Development  
In this presentation Dr. Arudchandran will describe the role of pain biomarkers in drug development and clinical practice. A discussion of the process of advancing biomarker candidates or biosignatures from discovery through FDA qualification, as well as integrating biomarkers into pain therapeutic development and management, will be provided. The NIH HEAL (Helping to End Addiction Long-Term) and the NINDS (The National Institute of Neurological Disorders and Stroke) pain biomarker programs and funding opportunities utilize a milestone-driven, rigorous approach aligned with the FDA biomarker qualification standards. The presentation will provide a brief overview of funded projects and the status of these programs. Additionally, the different approaches taken by project investigators will also be discussed pertaining to the integration of biomarkers and endpoints to facilitate the identification of non-addictive pain treatments. It will also illustrate how the program leverages various pain therapeutics and biomarker programs available under NIH HEAL.
Ram Arudchandran, Ph.D., Program Director, Division of Translational Research, National Institute of Neurological Disorders & Stroke, National Institutes of Health

1:30 pm The Recipe for Acute Pain Clinical Trials. Two Parts Science – One Part Art. Pointers and Pitfalls
In this presentation, Dr. Bertoch will examine the current state of acute pain trials and discuss the unappreciated nuances and potential pitfalls that can make or break an acute pain study.
Todd Bertoch, MD, Chief Executive Officer, CenExel JBR

2:00 pm Hope vs Hype: Can Psychedelic Drugs Bring Relief to Patients with Chronic Pain? 
Chronic pain is a complex biopsychosocial phenomenon that can impact every aspect of a patient’s life. Current treatments for chronic pain are inadequate, and often the most effective therapies involve a multimodal approach to address the physiological, emotional, and psychiatric factors that often coexist. Classic psychedelics, including psilocybin, LSD, and DMT, are currently under evaluation as potential treatments for numerous psychiatric conditions, but may hold promise as treatments for chronic pain. This presentation will review historical and recent evidence and propose a scientific rationale for why psychedelics might be effective treatments for chronic pain. Potential mechanisms of action will be reviewed, taking into context that psychedelics may impact not only pain perception, but also provide long-term improvements in mood, cognitive function, physical function, and quality of life.
Ryan Lanier, Ph.D., Director, Clinical Development & Abuse Liability, Pinney Associates

2:30 pm Afternoon Refreshment & Networking Break

3:00 pm Brain Penetrant P2X4 Receptor scFv Antibody Blocks Chronic Pain  
We design and engineer single chain Fragment variable (scFv) small antibody biologics targeting P2X4R and other targets preferentially present in chronic pain conditions. In the studies to be presented we determined effectiveness for (1) reversing/preventing pain-, anxiety-, and depression-like behaviors after a single scFv dose in chronic pain models and (2) diminishing excitability of sensory ganglia neurons in primary culture evidenced by increasing their rheobase (current injection required to elicit firing) in whole-cell patch-clamp electrophysiological recordings, which may underlie the anti-allodynic action of the scFv.
Karin Westlund High, Ph.D., Professor and Vice-Chair for Research, Department of Anesthesiology & Critical Care Medicine, University of New Mexico Health Sciences Center
Sascha Alles, Ph.D., Assistant Professor, Department of Anesthesiology & Critical Care Medicine, University of New Mexico School of Medicine

3:35 pm A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1)
RELIEF-DPN-1 is a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of painful diabetic neuropathy, also referred to as diabetic peripheral neuropathic pain. In this presentation, Dr. Patel will discuss the framework for this trial, preclinical basis for the program and the results from their recent Phase 2 trial.
Anand Patel, MD, Chief Medical Officer, Certified Principal Investigator, Conquest Research

4:05 pm Neuroimaging & AI-based Preclinical Analgesic Drug Evaluation Platform: Focusing on Spontaneous Ongoing Pain 
Spontaneous ongoing pain, a major clinical problem of chronic pain, is challenging to diagnose and treat compared to stimulus-evoked pain. However, there still exists a mismatch in pain type between the animal model and humans (i.e., evoked vs. spontaneous), which obstructs the translation of knowledge from preclinical animal models into objective diagnosis and effective new treatments. In this study, we developed a deep learning algorithm to decipher spontaneous pain information from brain cellular calcium signals recorded by two-photon imaging in awake, head-fixed mice. Our AI model determines the intensity and time point of spontaneous pain even during chronic neuropathic pain state and assesses the efficacy of analgesics, thereby providing a quantitative and real-time preclinical evaluation platform for pain medicine.
Sun Kwang Kim, KMD, Ph.D., Founder & CEO, Neurogrin, Professor & Chairman of Physiology, Kyung Hee University College of Korean Medicine

4:35 pm PTM Discovery Leads to Enzyme, Pathway and Novel Pain Drug Target Discovery 
In 2016, the polar chemistry of activity-based protein profiling (ABPP) probes was reversed by deploying the hydrazine pharmacophore found in old CNS drugs. The first thing it discovered was a new type of post-translational modification ("Glox") that was not predicted by genetics and found in proteins that had not been studied previously, secernin3 (SCRN3). Six years later, our data implicate SCRN3 as a novel non-opioid target for pain characterized by Glox activity that is druggable with small molecules that have low abuse potential. This presentation outlines our major findings and future directions to validate this target and others.
Megan Matthews, Ph.D., Principal Investigator, Assistant Professor of Chemistry, University of Pennsylvania

5:05 pm Cocktail Reception

November 15, 2022
 (all times Eastern US time)

8:25 am Chairperson's Opening Remarks
William Schmidt, Ph.D.
, President, Northstar Consulting

8:30 am Treating Chronic Pain with Localized Delivery of CA8 Gene Therapy 
The goals of this talk are to: - Describe the mechanism-of-action for carbonic anhydrase-8 (CA8) as novel non-opioid analgesic drug candidate that activates Kv7 channels - Describe the pros and cons of localized peripheral nervous system (PNS) delivery of CA8 using replication defective (rd)HSV gene therapy to produce long-lasting analgesia - Describe proof-of-concept studies of PNS targeting CA8 rdHSV-mediated gene therapy for the treatment of chronic pain due to knee osteoarthritis.
Roy Clifford Levitt, MD, Clinical Professor, Anesthesiology, Perioperative Medicine & Pain Management, University of Miami School of Medicine, Founder, Executive Chairman, Adolore Biotherapeutics

9:00 am Discovery of 4ET1103, a Peripherally-restricted MNK Inhibitor for the Treatment of Neuropathic Pain 

This presentation will give an introduction to the target, mitogen activated protein kinase-interacting kinase (MNK), and its relevance to treating pain. The talk will provide an overview of the medicinal chemistry optimization program that led to the discovery of clinical candidate, 4ET1103. Key efficacy and PK studies of 4ET1103 will be shown, and the path towards IND-filing will be reviewed.
James Sahn, Ph.D., VP of Drug Development, 4E Therapeutics

9:30 am Positive Allosteric Modulators of Human MAS-related G Protein-coupled Receptor X1 (MRGPRX1) for the Treatment of Neuropathic Pain 

Positive allosteric modulators (PAMs) of mas-related G-protein coupled receptor X1 (MRGPRX1) represent a promising new class of agents to treat pain by preferentially activating the receptors at the central terminals of primary sensory neurons, minimizing itch side effects caused by the activation of these receptors on the peripheral nerves. Our collaborative efforts supported by NIH's HEAL Initiative towards developing potent, orally available, thieno[2,3-d]pyrimidine-based MRGPRX1 PAMs will be presented.
Takashi Tsukamoto, Ph.D., Associate Professor of Neurology and Pharmacology, Johns Hopkins University

10:00 am Morning Refreshment & Networking Break 

10:30 am PANEL Session: Novel Molecular Targets and Approaches for Pain Therapeutics: Will Benefit Overcome Risk?

To date, the success rates for novel pain therapeutics across all pain conditions is roughly 2%. In contrast, success rates for all pain therapeutics regardless of novelty but for more specific pain conditions such as nociceptive or neuropathic pain are higher (~10%). Because many non-novel therapeutics have abuse potential, there is general agreement that efforts focused on the development of novel therapeutic entities are critical to achieving the goal of pain management without abuse liability. This panel discussion will focus on the potential promise of novel therapeutic targets along with the associated risks that have plagued the development of new pain therapeutics devoid of abuse potential. All of the panelists in this session will address the benefit: risk evaluation by describing the promise of their new therapeutic target in the context of associated risk and challenges.
Moderator: Mary Ann Pelleymounter, Ph.D., Program Director, NINDS, Division of Translational Research, National Institutes of Health
Sascha Alles, Ph.D., Assistant Professor, Department of Anesthesiology & Critical Care Medicine, University of New Mexico School of Medicine
James Sahn, Ph.D., VP of Drug Development, 4E Therapeutics
Roy Clifford Levitt, MD, Clinical Professor, Anesthesiology, Perioperative Medicine & Pain Management, University of Miami School of Medicine, Founder, Executive Chairman, Adolore Biotherapeutics
Takashi Tsukamoto, Ph.D., Associate Professor of Neurology and Pharmacology, Johns Hopkins University

Karin Westlund High, Ph.D., Professor & Vice-Chair for Research, Department of Anesthesiology & Critical Care Medicine, University of New Mexico
Selwyn Jayakar, Ph.D., Instructor in Neurology, Boston Children's Hospital, Harvard Medical School

11:15 am PNPase Inhibition as an Effective Treatment for Chronic Pain Disorders 

Chronic pain disorders (e.g., interstitial cystitis, hemorrhagic cystitis, chemotherapy-induced peripheral neuropathy or CIPN) are among the most difficult to treat. We propose the novel concept of reversing or restoring these dysfunctions by redirecting purine metabolism using an inhibitor of purine nucleoside phosphorylase (PNPase). Our preclinical findings demonstrate that inhibiting PNPase exert beneficial anti-inflammatory and tissue-protective effects in various target organ systems include the lower urinary tract and nervous system.
Lori Birder, Ph.D., Professor of Medicine & Pharmacology and Chemical Biology, University of Pittsburgh School of Medicine

11:45 am Proof of Concept Studies in Pain - Model Selection and Design Considerations 

In this presentation Dr. Singla will provide a basic overview for drug developers and researchers on the most common acute postoperative and chronic pain models available for US regulatory approval of a new pain drug, and provide some data that can help make key decisions on model selection and study design.
Neil Singla, MD, Chief Scientific Officer, Lotus Clinical Research

12:15 pm Luncheon 

1:15 pm Chronic Post Surgical Pain Syndromes: The Study Population for Neuropathic Pain Analgesic Drug Development That Will Replace Post Herpetic Neuralgia 

This presentation will examine recent and ongoing PH2 and PH3 RCTs in subjects with chronic post surgical neuropathic pain syndromes after mastectomy, inguinal hernia repair, total joint replacement and other surgical procedures. Taken together, these chronic neuropathic syndromes comprise the largest treatment population for chronic high impact pain in the United States where over 60 million surgeries are performed annually. This talk will provide an overview on the study design and study conduct issues related to this population by the principal investigator of the largest completed and ongoing global RCTs. Dr. Markman will explore lessons learned about operational challenges such as recruitment and subject validation as well as the latest evidence on phenotyping and assay sensitivity of trial designs in this population.
John Markman, MD, Vice Chair for Clinical Research; Director, Translational Pain Research Program; Prof. of Neurosurgery and Neurology, University of Rochester

1:45 pm Development of an Oral Analgesic with Reduced Liabilities 

Epiodyne has developed an orally bioavailable drug-like small molecule EPD2520: a mu opioid receptor partial agonist and kappa opioid receptor antagonist. In pre-clinical assays EPD2520 exhibits analgesic efficacy comparable to oxycodone, with little to no respiratory depression, and with apparently less self-administration liability than buprenorphine. IND enabling studies are ongoing and EPD2520 is expected to enter clinical trials in 2023.
Neil Schwartz, Ph.D., VP of Research, Epiodyne

2:15 pm Overcoming the Liver Toxicity Associated with Acetaminophen Via a New Class of Small Molecule Non-Opioids 

Development of a novel non-opioid without liver and kidney toxicity currently in Phase 1 trials will be discussed. The lead asset, SRP-3D (DA), is unique among currently available medicines for pain treatment as it lacks the risks of abuse and liver and kidney toxicity. A current NIH/NINDS STTR ‘fast-track’ grantsupports this work. The mechanisms for the lack of liver toxicity and the central analgesia have been deciphered. These known MOAs significantly de-risk the current Ph 1 and planned Ph 2a trials.
Hernan Bazan, MD, CEO & Co-Founder, South Rampart Pharma, Endowed John Ochsner Professor Innovation, Ochsner Health

2:45 pm End of Conference

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