November 14-15, 2022 | Washington, DC

Identifying and Advancing Novel Pain Drugs Through Clinical Development and Commercialization

2022 Conference Agenda

The FULL 2022 Summit Agenda has not yet been announced. Please check back in the coming days for updates to this page.

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 Prof., Anesthesiology, Perioperative Medicine & Pain Management, Univ. of Miami Miller School of Medicine, Founder, Executive Chairman, Adolore Biotherapeutics

Discovery of 4ET-03-053, 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, 4ET-03-053. Key efficacy and PK studies of 4ET-03-053 will be shown, and the path towards IND-filing will be reviewed.
James Sahn, Ph.D., VP of Drug Development, 4E Therapeutics

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

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

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

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

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

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.
Herman Bazan, MD, CEO & Co-Founder, South Rampart Pharma

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

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

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, CPI, Chief Medical Officer, Certified Principal Investigator, Conquest Research

The FULL 2022 Summit Agenda has not yet been announced. Please check back in the coming days for updates to this page.

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