Clinical-Stage Biopharmaceutical Company

Targeting the Molecular Cause of Opioid Dependence

ATX-1209 is a first-in-class μ-opioid receptor modulator designed to reduce opioid-induced physical dependence — without affecting analgesia or precipitating withdrawal.

The Opioid Crisis

A Public Health Emergency With No Adequate Treatment

The United States opioid crisis has claimed over 1 million lives since 1999 — and the problem of physical dependence remains largely unsolved for the millions of patients who legitimately need opioids for pain.[1]

54,000+
Opioid-related overdose deaths
in the U.S. in 2024[2]
5–8 Million
Americans on long-term
opioid therapy for chronic pain[3]
Nearly All
Chronic opioid therapy patients
develop physical dependence[4]
0
FDA-approved treatments for
opioid-induced physical dependence (OIPD)
or Neonatal Opioid Withdrawal Syndrome (NOWS)
The Physical Dependence Problem
Physical dependence develops in the majority of patients on long-term opioid therapy and is distinct from addiction. In these patients, physical dependence manifests as an ‘interdose withdrawal’, with symptoms such as anxiety, restlessness, pain sensitization, and dysphoria that emerge between doses. These symptoms drive dose escalation, compulsive use patterns, and, ultimately, inability to taper or discontinue opioids even when medically appropriate. No approved pharmacotherapy exists to address this core mechanism.
Why Existing Approaches Fall Short
Current opioid antagonists (naltrexone, naloxone) are inverse agonists that precipitate acute withdrawal and block analgesia, making them unsuitable for patients actively receiving opioid therapy. Partial agonists (buprenorphine) typically require opioid abstinence and withdrawal prior to induction, carry their own dependence liability, and are not indicated for treating opioid-induced physical dependence in pain patients.[5] ATX-1209 is the only known compound designed to treat physical dependence while patients remain on opioid therapy — addressing the problem at its molecular root.[6]
Sources
[1] CDC. About Overdose Prevention, 2026.
[2] KFF analysis of CDC WONDER data. Opioid Overdose Deaths: National Trends, Feb 2026.
[3] NIH Pathways to Prevention Workshop. The Role of Opioids in the Treatment of Chronic Pain, 2014.
[4] Ballantyne JC, Mao J. Physical dependence is a predictable pharmacological consequence of chronic opioid receptor agonism. N Engl J Med; 2003;348:1943–5.
[5] Sadee W, Oberdick J, Wang Z. Biased opioid antagonists as modulators of opioid dependence. Molecules 2020;25:4163.
[6] Sadee W, McKew JC. Ligand-free signaling of GPCRs: relevance to µ opioid receptors. Molecules 2022;27:5826.
Our Science

A New Class of Opioid Modulation

ATX-1209 (oral 6β-naltrexol) represents a mechanistically distinct approach to opioid-induced physical dependence — not an agonist, not a classical antagonist.

⚙

Neutral µ-Opioid Receptor Modulator

At therapeutic doses (<10% MOR occupancy), ATX-1209 selectively binds the constitutively active MOR-µ* state induced by chronic opioid exposure, gradually driving reconversion to the resting MOR-µ state. Unlike inverse agonists (naltrexone, naloxone), it does not suppress basal receptor signaling or precipitate withdrawal.

Sadee & McKew, Molecules 2022 · Sadee et al., Molecules 2020

◎

Preserves Analgesia

ATX-1209 is approximately 100-fold less potent than naltrexone in blocking opioid analgesia, enabling reduction of physical dependence while patients continue to receive the full pain-relieving benefit of their opioid therapy — a critical differentiation for chronic pain patients.

Yancey-Wrona et al., Pharmacol Biochem Behav 2011

Mechanism of Action — MOR-µ* Reconversion

Chronic opioid exposure drives the µ-opioid receptor into a sustained, ligand-free constitutively active state (MOR-µ*) that perpetuates dependence independent of agonist. ATX-1209 catalyzes the gradual reversal of MOR-µ* back to the resting MOR-µ state — a process termed retrograde addiction modulation.

MOR-μ Resting State Opioid Naïve Opioid Agonist (chronic exposure) MOR-μ* Constitutively Active Ligand-Free Dependence Driver ATX-1209 Gradual Reconversion ATX-1209 ✓ Analgesia preserved ✗ Physical dependence ✗ Interdose withdrawal ✗ Hyperalgesia ✗ Respiratory depression ✗ Constipation OPIOID DEPENDENCE

Adapted from Sadee W, McKew JC. Molecules 2022, 27, 5826.

Pipeline

Multi-Indication Development Strategy

A single molecule with therapeutic potential across the continuum of opioid-induced harm — from chronic pain dependence to neonatal withdrawal.

Indication Discovery Preclinical Phase 1 Phase 2 Phase 3
Opioid-Induced Physical Dependence in Chronic Opioid Pain Therapy
Phase 1

ATX-1209 is a first-in-class μ-opioid receptor modulator designed to reduce opioid-induced physical dependence without affecting analgesia or precipitating withdrawal. By targeting the constitutively active MOR-μ* receptor state, it reverses dependency pathways in the brain.
Opioid Use Disorder (OUD)
Phase 1

Targeting the reduction of craving and withdrawal symptoms, ATX-1209 stabilizes the µ-opioid receptor signaling in the brain's reward center to prevent relapses and support long-term recovery in OUD patients.
Neonatal Opioid Withdrawal Syndrome (NOWS)
Preclinical (In Progress)

A critical, high-urgency unmet need in infants born to mothers on opioid maintenance therapy. ATX-1209 acts as a gentle receptor modulator to ease neonatal withdrawal symptoms safely and reduce NICU stay times.
Combat & Acute Pain (Opioid Co-formulation)
Discovery (Exploratory)

Co-formulation of ATX-1209 with standard acute opioid analgesics (e.g. fentanyl, morphine) for field medic use. The goal is to preserve immediate pain relief while pre-emptively blocking the receptor changes that trigger dependence.
Cancer Pain Adjunct
Discovery (Exploratory)

Adjunctive therapy for cancer patients requiring high-dose, long-term opioid analgesia. ATX-1209 aims to prevent the progressive development of severe tolerance, allowing patients to stay on lower, safer pain-management doses.
Lead Indication
Follow-on
Exploratory
In Progress / Next Stage Planned
Leadership

World-Class Drug Development Expertise

Our team combines decades of experience in opioid pharmacology, CNS drug development, regulatory strategy, and clinical operations.

Senior Management
Aaron Schuchart
Aaron Schuchart
President & Chief Executive Officer
Bio
For the past thirty years, Aaron has held senior leadership positions in Operations, Finance, Business Development, and Corporate Strategy spanning the therapeutics, industrial, and agricultural sectors. Most recently, he was Chief Business Officer of Lumos Pharma, a publicly traded biotech company. Previously Head of Business Development and Strategy for the Diagnostics division of Novartis, Managing Director of Proaltus Partners, and held senior positions at Amgen. BBA, Texas Tech; MBA, Anderson School at UCLA.
LinkedIn
Wolfgang Sadee, PhD
Wolfgang Sadee, PhD
Chief Scientific Officer & Founder
Bio
A globally recognized authority in opioid pharmacology and personalized medicine. Professor Emeritus at Ohio State University College of Medicine and UCSF. Over 400 publications spanning opioid pharmacology and pharmacogenomics. Recognized by ScholarGPS (2025) in the top 0.05% of scholars worldwide. Originating scientist behind the MOR-µ* constitutive activity model and ATX-1209.
LinkedIn
Bruce Imbert, MD, PhD, MPH
Bruce Imbert, MD, PhD, MPH
Chief Medical Officer & Head of R&D
Bio
Bruce Imbert, MD, PhD, MPH, has more than 20 years of clinical development, regulatory and strategy at Indivior, Tempero Bio and Pear Therapeutics. He is a proven leader in developing CNS therapies, including significant accomplishments in the areas of addiction and psychiatry. He most recently led the development programs for a long-acting injectable buprenorphine formulation approved for the treatment of OUD, and an intranasal opioid antagonist for opioid overdose reversal.
LinkedIn
Laurence Nore, MBA
Laurence Nore, MBA
Fractional Chief Operating Officer
Bio
Over 25 years of operational, financial, and business development experience in biopharmaceuticals including Amgen, PDL Biopharma, and Roche Diagnostics. Most recently at IgGenix, established the Australian subsidiary and managed the CRO and clinical sites for their First-in-Human trial.
LinkedIn
Board of Directors
Rick Hawkins
Rick Hawkins
Founder & Chairman
Bio
40-year veteran in biotechnology and pioneer in the CRO/CDMO industries. Founded multiple companies with notable exits including Pharmaco/PPD and Sensus/Pfizer. Most recently Founder, President & CEO of Lumos Pharma. Current board member of Savara and Plus Therapeutics; advisor to the President’s Innovation Council at UT Austin.
LinkedIn
Jon Saxe
Jon Saxe
Board Member & Lead Director
Bio
Extensive governance experience across 25+ boards with multiple successful exits. Former VP of Corporate Development & Licensing at Hoffmann-La Roche, CEO of Synergen, and President of PDL Biopharma (1995–2000). Currently Lead Director of Kyto Technology and Life Sciences.
LinkedIn
Phil Skolnick, PhD, DSc
Phil Skolnick, PhD, DSc (hon.)
Board Member
Bio
Phil Skolnick has served in both the public and private sectors. Following a 25-year career at the NIH Intramural Research Program, he was appointed a Lilly Fellow in Neuroscience. Three years later, he and his colleagues founded DOV Pharmaceuticals, a NASDAQ listed corporation. At DOV, he served as Chief Scientific Officer and later as President and CSO. He rejoined the NIH in 2010 as Director, Division of Therapeutics and Medical Consequences at the National Institute on Drug Abuse. He returned to the private sector in 2017 as Chief Scientific Officer at Opiant Pharmaceuticals, which was listed on NASDAQ in 2018. Opiant was acquired by Indivior in March 2023. Skolnick served as a Fellow at Indivior from 2023–2025.
LinkedIn
John D. Harris
John D. Harris
Board Member
Bio
As a member of Aether Therapeutics’ Board of Directors, John Harris brings a strong background in clinical trials, and leadership experience at large, medium and start-up organizations in the biotech and cell therapy fields. He currently is the CEO of BioFire Defense and previously served as Aether’s President & CEO between June 2022 and January 2025. John’s deep operational, executive and market development capabilities are assets to the board.
LinkedIn
John McKew, PhD
John McKew, PhD
Board Member
Bio
John McKew is President and Chief Scientific Officer of Lumos Pharma. Dr. McKew has twenty-seven years of experience developing novel therapeutics where he successfully advanced therapies through preclinical and into clinical development. Prior to Lumos Pharma, Dr. McKew served as V.P. of research at aTyr Pharma where he led a research team discovering and advancing protein-based therapeutics for rare diseases. He has also served as Acting Scientific Director for the National Center for Advancing Translational Science (NCATS) intramural group, a part of the National Institutes of Health (NIH).
LinkedIn
Advisors
Bob Davis
Bob Davis
Senior Advisor, Clinical & Regulatory
Bio
Bob Davis has over 35 years of experience in biopharma and global CROs designing, advising and conducting clinical trials at Lumos, Parke Davis, Searle, Sensus, Pharmaco among others. He has also been part of the development of multiple drugs that received FDA approval.
LinkedIn
Investors

Why Aether Therapeutics

Aether Therapeutics is advancing a differentiated, first-in-class therapeutic platform to address the molecular cause of opioid-induced physical dependence — a significant unmet medical need affecting millions of patients worldwide.

◆
Novel Mechanism
ATX-1209 is the only known neutral µ-opioid receptor modulator in clinical development — a mechanistically distinct approach that targets the constitutively active MOR-µ* state responsible for physical dependence.
▣
Significant Unmet Need
No approved therapy exists for preventing or mitigating physical dependence in patients maintained on opioids to treat chronic pain. Neonatal Opioid Withdrawal Syndrome (NOWS) similarly lacks a targeted pharmacotherapy. ATX-1209 is designed as a daily oral adjunct that reduces dependence while preserving analgesia.

Safa et al., Front Pharmacol 2021

Key Publications

Scientific Foundation

The scientific basis for ATX-1209 is grounded in two decades of peer-reviewed research on µ-opioid receptor constitutive activity, opioid pharmacology, and 6β-naltrexol pharmacodynamics.

2023
Ligand-free signaling of G-protein-coupled receptors: physiology, pharmacology, and genetics
Sadee W, McKew JC
Molecules · Expanded GPCR Signaling Framework
View on PubMed →
2022
Ligand-free signaling of G-protein-coupled receptors: relevance to µ opioid receptors in analgesia and addiction
Sadee W, McKew JC
Molecules · MOR-µ* Constitutive Activity & ATX-1209 Model
View on PubMed →
2021
Pharmacological prevention of neonatal opioid withdrawal in a pregnant guinea pig model
Safa A, Lau AR, Aten S, Schilling K, Bales KL, Miller VA, Fitzgerald J, Chen M, Hill K, Dzwigalski K, Obrietan K, Phelps MA, Sadee W, Oberdick J
Frontiers in Pharmacology · NOWS Preclinical Data
View on PubMed →
2020
Biased opioid antagonists as modulators of opioid dependence: opportunities to improve pain therapy and opioid use management
Sadee W, Oberdick J, Wang Z
Molecules · Biased Antagonist & 6β-Naltrexol Framework
View on PubMed →
2016
Preferential delivery of an opioid antagonist to the fetal brain in pregnant mice
Oberdick J, Ling Y, Phelps MA, Yudovich MS, Schilling K, Sadee W
J Pharmacol Exp Ther. · Fetal Brain Selective Antagonist Delivery
View on PubMed →
2011
6β-Naltrexol, a peripherally selective opioid antagonist that inhibits morphine-induced slowing of gastrointestinal transit: An exploratory study
Yancey-Wrona J, Raymond TJ, Mercer HK, Sadee W, Bilsky EJ
Pain Med. · Peripheral Selectivity & GI Motility Study
View on PubMed →
2009
The relative potency of inverse opioid agonists and a neutral opioid antagonist in precipitated withdrawal and antagonism of analgesia and toxicity
Sirohi S, Dighe SV, Madia PA, Yoburn BC
J Pharmacol Exp Ther. · Neutral Antagonist vs. Inverse Agonist Potency
View on PubMed →
2005
In vivo characterization of 6β-naltrexol, an opioid ligand with less inverse agonist activity compared with naltrexone and naloxone in opioid-dependent mice
Raehal KM, Lowery JJ, Bhamidipati CM, Paolino RM, Blair JR, Wang D, Sadée W, Bilsky EJ
J Pharmacol Exp Ther. · 6β-Naltrexol In Vivo Characterization
View on PubMed →
News & Press Releases

Latest Updates

March 18, 2026
Aether Therapeutics Strengthens Leadership with Three Key Appointments
Dr. Bruce Imbert and Laurence Nore join the senior management team as CMO & Head of R&D and Fractional COO, respectively. Dr. Phil Skolnick appointed to the Board of Directors.
December 2025
CSO Wolfgang Sadee Honored as Highly Ranked Scholar by ScholarGPS
Dr. Sadee recognized in the top 0.05% of scholars worldwide in personalized medicine and related disciplines in the 2025 Global Scholar Rankings by ScholarGPS.
Contact

Get in Touch

Aether Therapeutics is headquartered in Austin, Texas. For investor inquiries, partnership opportunities, or general information, please reach out.

General Inquiries
info@aetherthx.com
LinkedIn
Aether Therapeutics
About Aether Therapeutics

Aether Therapeutics is a clinical-stage biopharmaceutical company developing ATX-1209, a first-in-class oral μ-opioid receptor modulator targeting the molecular cause of opioid-induced physical dependence.

Austin, Texas

March 18, 2026

Aether Therapeutics Strengthens Leadership with Three Key Appointments

Company welcomes Dr. Bruce Imbert and Laurence Nore to the Senior Management Team and appoints renowned neuroscientist Dr. Phil Skolnick to the Board of Directors

Austin, TX — March 18, 2026 — Aether Therapeutics (“Aether”), a clinical-stage biopharmaceutical company dedicated to addressing opioid addiction and advancing non-addictive treatments for pain, today announced three significant leadership appointments: Dr. Bruce Imbert and Ms. Laurence Nore have joined the senior management team as Chief Medical Officer & Head of R&D and Fractional Chief Operating Officer, respectively. Additionally, Dr. Phil Skolnick has joined the company’s Board of Directors. Together, these appointments bring world-class scientific, clinical, and operational expertise to Aether as it advances its lead candidate, ATX-1209.

Bruce Imbert, MD, PhD, MPH, and Laurence Nore, MBA Strengthen Aether’s Management Team

Aether Therapeutics has appointed Bruce Imbert, MD, PhD, MPH, as Chief Medical Officer and Head of Research & Development and Laurence Nore, MBA, as Fractional Chief Operating Officer. Dr. Imbert is a globally experienced CNS drug developer and proven operational leader with deep expertise spanning addiction medicine, psychiatry and digital therapeutics. Appointed to the NIH/NIDA Medication Development Research Study Section, he brings a career encompassing the full development lifecycle – from preclinical strategy through regulatory approval and post-marketing execution – across multiple international markets. Most recently, he led the post-approval program at Indivior for a long-acting injectable buprenorphine formulation approved for the treatment of opioid use disorder, and an intranasal opioid antagonist indicated for opioid overdose reversal. His regulatory and clinical development track record in the addiction space makes him uniquely positioned to advance ATX-1209 from IND submission through global clinical development and regulatory approval.

Ms. Nore brings over 25 years of experience in senior operational, financial, and business development roles across the biopharmaceutical industry, and is recognized as a strategic and tactical leader in R&D project management, deal-making, and financings. Most recently, at IgGenix, she established and managed the company’s Australian entity and oversaw execution of the Phase 1 clinical program.

Phil Skolnick, Ph.D., D.Sc. (hon.), Joins Board of Directors

Aether Therapeutics is pleased to announce the appointment of Dr. Phil Skolnick to its Board of Directors. A renowned neuropharmacologist, Dr. Skolnick brings extraordinary drug development, regulatory, and business experience across pain, addiction, and neuropsychiatric medicine. He previously led the Division of Therapeutics and Medical Consequences at the National Institute on Drug Abuse (NIDA), where he oversaw a broad portfolio of CNS research and clinical development programs. Most recently, Dr. Skolnick served as Chief Scientific Officer of Opiant Pharmaceuticals, where he led the development of multiple programs for substance use disorders prior to the company’s acquisition by Indivior. He also served on the Board of Directors of Gilgamesh Pharmaceuticals, a neuropsychiatric biotech company that was recently acquired by AbbVie for up to $1.2 billion.

“Aether is pursuing a scientifically compelling and clinically urgent mission. The pharmacology underlying ATX-1209 represents a truly differentiated approach to chronic pain and opioid use disorder — one that I believe has significant potential to change how these conditions are treated. I am honored to join the Board and look forward to contributing to the company’s continued progress.”
— Phil Skolnick, PhD
“I am thrilled to welcome Bruce, Laurence, and Phil to the Aether Therapeutics family. Bruce brings extensive hands-on expertise in getting OUD therapies across the finish line with the FDA, and Laurence’s operational acumen, deal-making experience, and track record in running lean, effective clinical programs is central to our execution. Phil’s career is a testament to what is possible when rigorous science is paired with real-world drug development discipline — his experience at NIDA, Opiant, and Gilgamesh brings critical strategic and scientific capital that will help us achieve our mission. Together, these three leaders reflect our ambition and our confidence in ATX-1209’s potential to make a real difference for patients.”
— Aaron Schuchart, President & CEO

About Aether Therapeutics

Aether Therapeutics is a clinical-stage biopharmaceutical company seeking to address the global opioid crisis by targeting the molecular cause of dependence. The company’s lead candidate, ATX-1209, is a novel addiction modulator designed to mitigate opioid dependence and reverse the upregulated basal MOR signaling that drives addiction — while preserving analgesic efficacy and without inducing withdrawal or abuse liability. ATX-1209’s differentiated mechanism offers potential clinical utility across opioid use disorder, non-addictive pain therapy in combination with opioid agonists, and prevention and treatment of neonatal opioid withdrawal syndrome. Aether’s scientific foundation is built on the pioneering research of founder and Chief Scientific Officer Dr. Wolfgang Sadee, a globally recognized authority in opioid pharmacology and personalized medicine.

Contact: info@aetherthx.com
December 2025

CSO & Founder Wolfgang Sadee Honored as a Highly Ranked Scholar by ScholarGPS

Recognition Underscores Company’s Commitment to Excellence in Novel Pain and Addiction Therapeutics

Austin, Texas — December 2025 — Aether Therapeutics, a clinical-stage biopharmaceutical company developing safer therapeutics for pain and addiction, today announced that Dr. Wolfgang Sadee, CSO, has been honored as a Highly Ranked Scholar by ScholarGPS in the 2025 Global Scholar Rankings, placing him in the top 0.05% of scholars worldwide in personalized medicine and related disciplines.

This prestigious recognition reflects Dr. Sadee’s exceptional career trajectory, prolific publication record, and outstanding contributions to biomedical innovation — areas that directly align with Aether Therapeutics’ mission to transform pain management and addiction treatment through precision therapeutics.

“We are proud to see Wolfgang Sadee’s world-class expertise recognized on such a distinguished platform. His leadership in opioid research and personalized medicine has been instrumental in advancing our scientific strategy and bringing breakthrough solutions to patients who desperately need safer alternatives.”
— Aaron Schuchart, President & CEO

ScholarGPS rankings are determined by artificial intelligence and data science analysis of over 200 million publications and 3 billion citations, evaluating scholars across 30 million researchers and 120,000 institutions globally. The Highly Ranked Scholar designation honors exceptional lifetime achievement and recent contributions across specific scientific and clinical disciplines.

Privacy Policy

Last Updated: May 27, 2026

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Aether Therapeutics
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Location: Austin, Texas