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Restoring Resilience
Breaking the Cycle of Chronic Disease with Lodonal™, Attune Precision, and STARR
We are a clinical-stage biopharmaceutical company transforming how we treat complex, chronic diseases. Going beyond pharmaceuticals, we offer a unified platform that restores immune function, alleviates pain, supports mental health, and delivers real-time, personalized care through intelligent digital systems.
Our mission & Vision
Mission
To restore human resilience by addressing the root causes of chronic illness—delivering integrated, non-suppressive therapies that heal the immune system, relieve suffering, and empower mental and physical recovery.
We are not treating isolated symptoms. We are addressing the self-perpetuating cycle that drives chronic disease: stress → inflammation → pain → immune dysfunction → mental health decline. Our approach combines biological precision, psychological insight, and digital engagement to restore health and resilience from the inside out.
Backed by federal partnerships and readiness for rapid deployment, Attune is positioned to deliver scalable, non-addictive, and biologically intelligent care for high-need populations—across Long COVID, HIV non-responders, chronic pain, PTSD, and beyond.
Vision
To lead a global health transformation through solutions that unify biology, mental health, and technology—creating a future where precision immunotherapy and digital care ecosystems replace outdated, fragmented approaches to chronic disease.
Meet the People
Leadership Driving Resilience
Our team brings unparalleled expertise in federal healthcare, biotech innovation, and digital therapeutics—positioning us for rapid deployment and value creation.
Chief Executive Officer
Noreen Griffin
Visionary biotech entrepreneur and founding CEO of Biostax, leading innovation in immunotherapy and regenerative medicine with a proven track record in clinical development, global partnerships, and strategic commercialization.
President
Dr. John Rosa
Internationally recognized leader in integrative health, addiction recovery, and mental wellness; drives Attune Biotech’s mission to bridge neuroscience, immunology, and AI-driven therapeutics for whole-person healing.
Chief Operating Officer
Kelly O’Brian Wilson
Biotech and systems design leader with 25+ years in project management, data integration, and operational transformation.
Chief Financial Officer
Glen Farmer
Healthcare finance and accounting leader; expertise in budgeting/forecasting, treasury, tax, and internal controls; former U.S. Controller at iAnthus and Director of Finance at Premier’s Integrated Specialty Pharmacy.
Senior Strategic Advisor
The Hon. Thomas G. Bowman
Former Deputy Secretary of the U.S. Department of Veterans Affairs. National leader in veterans’ healthcare policy and interagency coordination.
Senior Strategic Advisor
Daniel Faraci
CEO, Grassroots Political Consulting. Government relations strategist with two decades of intelligence, policy, and biotech advocacy experience.
Senior Strategic Advisor
Dr. Peter F. Demitry
Former Assistant Air Force Surgeon General. Expert in military medicine, federal innovation pathways, and integrative health research.
Advisory Board Member
Susan St. Ledger
Technology executive and philanthropist. Former Salesforce and Okta President championing scalable health and social impact innovation.
Advisory Board Member
Eric Kussin
Former sports executive and global mental health innovator; Founder of 5in5 Inc. and #SameHere Global, advancing technology-driven emotional wellness.
Regulatory Strategy Expert
Dr. Abhijath Murali
PharmD-qualified Regulatory Affairs leader with 8+ years of industry experience and RAPS-certified across US, EU, and global regulatory frameworks.
Advisory Board Member
Alan González Cota
Board-certified anesthesiologist and interventional pain specialist (FIPP) with advanced expertise in minimally invasive procedures and chronic pain management.
Advisory Board Member
Dr. Angelo Falcone
Emergency medicine leader and healthcare entrepreneur. Integrative medicine innovator bridging clinical care and longevity science.
Advisory Board Member
Dr. Andrew Pleener
Founder of Regional Psychiatry. Psychiatrist and trauma expert advancing mind-body medicine and mental wellness innovation.
Advisory Board Member
Dr. Rick Rosa
Neurorehabilitation and pain specialist. A global expert in sports recovery, brain injury, and neuroinflammation.
Advisory Board Member
Dr. Heather Zwickey
Provost and VP of Research, NUNM. Internationally recognized immunologist and pioneer in gut-brain-immune axis research.
The Resilience Revolution
Rewriting the Story of Chronic Disease
The Hidden Crisis: A World Unraveled by Chronic Disease
Imagine a silent storm sweeping across societies: Chronic disease—driven by immune dysfunction, inflammation, neuroimmune imbalance, and mental health deterioration—is a multi-trillion-dollar annual global problem, with the U.S. alone absorbing over $4T per year through avoidable deaths, lost productivity, and healthcare overload. Societally, they fracture families, sideline workforces, and widen inequalities, with rural communities hit hardest by barriers to care.
The Root Causes: A Dysregulated Symphony
At the core? A cascade of dysregulation: Systemic inflammation as the conductor gone rogue, immune system chaos silencing defenses, opioid receptor glitches amplifying pain signals, and neurochemical imbalances hijacking mood and cognition. These aren't random; they're interconnected, turning the body's harmony into discord. Emerging evidence points to chronic inflammation as the "hidden driver," bridging physical ills to mental fog and accelerated aging.
The Vicious Cycle: How Stress Fuels the Fire
Psychological stress—from mental trauma or isolation—mingles with physical assaults like infections or physical trauma while chronic pain, and sleep deprivation steals recovery time. This toxic brew ignites Toll-Like Receptor 4 (TLR4) activation on immune cells and glial cells in the brain, sparking a proinflammatory alarm. Opioid receptors, meant to soothe, now misfire, blocking natural painkillers and growth signals.
Downstream? A domino fall:
- Cytokine Surge: IL-6 and TNF-α skyrocket, breaching barriers to inflame the brain (neuroinflammation) and gut, disrupting the microbiome and inviting autoimmune flares.
- Mitochondrial Meltdown: Energy factories falter, starving cells and worsening fatigue in things such as Long COVID or fibromyalgia.
- Cortisol Chaos: Adrenal overdrive floods the system, eroding resilience and fueling anxiety/PTSD loops.
- Cellular Havoc: Proliferation runs amok (risking cancer), telomeres fray (premature aging), and neurochemicals like serotonin/dopamine plummet, deepening depression and addiction.
Changing the Narrative: Lodonal™ – The Reset for Resilience
Enter Lodonal™ (JKB-122), our patented low-dose naltrexone (LDN)-based immune modulator: Not a blunt suppressor, but a precise restorer. At ultra-low doses (1-5mg), it targets the storm's epicenter through a biphasic, hormetic mechanism—where "less is more," flipping potential harm into healing.
By temporarily binding to mu, delta, and opioid growth factor (OGF) receptors with partial affinity, Lodonal creates a brief blockade—triggering a compensatory 2-3x surge in endogenous opioids (endorphins and enkephalins). This rebound restores natural pain gating, curbs excessive B- and T-cell proliferation (easing autoimmune flares), and amplifies OGF signaling to dial down inflammation and even temper cancer-promoting growth—while safeguarding telomeres against premature aging. Simultaneously, it antagonizes Toll-Like Receptor 4 (TLR4) on microglia and macrophages, slashing proinflammatory cytokines (IL-6, TNF-α) to quiet CNS fog and peripheral pain loops.
This dual-action shifts the tide across your cycle: Endorphin surges counter cortisol chaos and neurochemical dips (lifting PTSD/depression veils); restored OGF/TLR4 balance revives mitochondrial energy (banishing Long COVID fatigue); blunted inflammation mends gut barriers and immune harmony, breaking addiction crutches and sleep thieves. Paired with STARR's AI-driven stress tracking, it's a closed-loop revolution: 67% opioid reduction, non-addictive pain relief, and real-time resilience building—as we gear up for Q4 2025 IND launches in HIV non-responders and Long COVID. (Disclaimer: Investigational; based on emerging preclinical/clinical data. Not FDA-approved for all indications. Consult your HCP.)
How Lodonal Works: The Hormetic Edge
Hormesis—the principle that low doses of a stressor (like LDN) can spark adaptive benefits, unlike high doses that overwhelm—unlocks Lodonal's power. High-dose naltrexone (50mg+) fully occupies opioid receptors, blocking endorphin surges and missing TLR4's inflammatory switch. But at low doses? Partial binding allows rebound magic while hitting TLR4.
| Dose Level | Opioid Receptor Effect | TLR4 Effect | Key Outcomes (Emerging Data) |
|---|---|---|---|
| High (50mg+) | Full blockade: No upregulation or endorphin rebound—sustained suppression. | Minimal affinity: Inflammation unchecked. | Addiction treatment focus; risks rebound hyperalgesia without surge. |
| Low (1-5mg, Lodonal) | Temporary partial blockade: 2-3x endogenous opioid surge + OGF upregulation. | Direct antagonism: Glial/macrophage calming. | Pain reduction, inflammation drop, immune balance—multi-indication reset. |
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ATTUNE BIOTECH
Market Share Pipeline
Attune Pipeline document provides details into our innovative therapeutic candidates and clinical evidence
COVID Long Haul (EUA)
01.
Addressing the Long-Term Impact of COVID-19
Indication
This targets the persistent and often debilitating symptoms that linger after the acute phase of COVID-19 infection. These symptoms can include fatigue, cognitive dysfunction (“brain fog”), pain, and other issues.
Market Opportunity
Large patient population (10-30 million patients), indicating a substantial market. There’s a strong need for effective treatments to alleviate the burden of Long COVID. Regulatory
Regulatory Strategy
The strategy includes pursuing Emergency Use Authorization (EUA), which can provide a faster pathway to make Lodonal available to patients during the public health emergency.
HIV Treatment Portfolio
Improving Outcomes in HIV Management
Indication
02.
Attune is exploring Lodonal’s use in addressing unmet needs within HIV treatment, specifically for non-responders. This suggests a focus on patients who don’t achieve adequate viral suppression or immune reconstitution with standard antiretroviral therapy. There’s also mention of potential as an adjunct therapy, meaning Lodonal could be used in combination with other HIV treatments.
Market Opportunity
This indicates a focus on improving outcomes for patients with treatment-resistant HIV, a population with significant medical needs.
PTSD Treatment
Developing a Novel Approach to PTSD
Indication
03.
This application aims to treat Post-Traumatic Stress Disorder, a chronic mental health condition that can develop after experiencing or witnessing a traumatic event.
Market Opportunity
PTSD affects a significant number of individuals, and there’s a need for new and effective treatment options.
Partnerships
Strategic current and future partnerships across DoD, VA, first responders, and mental health systems to advance percision care for PTSD.
Cancer Adjunct Therapy
Supporting Patients Through Cancer Treatment
Indication
04.
This application explores the use of Lodonal as an adjunct therapy in cancer treatment. This means it would be used in addition to primary cancer treatments (like chemotherapy or radiation) to potentially improve outcomes or reduce side effects.
Market Opportunity
This indicates a broad potential to improve the overall management of cancer patients.
Chronic Pain & Inflammation
Targeting the Root of Chronic Disease
Indication
05.
This is a broad category, as chronic inflammation underlies many diseases. This suggests Attune is investigating Lodonal’s potential to address the inflammatory component of various chronic conditions.
Market Opportunity
Chronic inflammation affects a vast patient population, representing a substantial market.
Autoimmune Hepatitis
(Orphan)
Addressing a Rare Liver Disease
Indication
06.
Developing Lodonal as a treatment for autoimmune hepatitis, a rare chronic liver disease.
Market Opportunity
High unmet need for effective treatments for this rare disease, with potential regulatory and market incentives through Orphan Drug designation.
Liver Disease, Indication
07.
Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly NAFLD) and its progressive form, metabolic dysfunction-associated steatohepatitis (MASH), have become the leading cause of liver transplantation in the United States, particularly among veterans. There are no FDA-approved therapies that halt or reverse progression, and current metabolic-focused agents (e.g., GLP-1s, FGF21 analogs) do not address the underlying immune dysfunction that drives disease progression. Market Opportunity: JKB-122 is a novel, first-in-class oral immunomodulator that restores immune homeostasis by antagonizing Toll-like receptor 4 (TLR4)—a critical upstream driver of liver inflammation, fibrosis, and systemic symptoms. It is also the first agent to advance into late-stage development for autoimmune hepatitis (AIH) as a steroid-sparing therapy.
JKB-122 is
- FDA-cleared for Phase 2b trials in MASLD and MASH
- FDA-cleared for Phase 2b/3 trials in AIH
- U.S.-manufactured, GMP-compliant, and scalable
- Oral, low-cost, and ready for integration into VA, DoD, and BARDA infrastructure.
1 in 3 Adults
Affected by Chronic Diseases Worldwide
$40-60B
Total Addressable Market Across Indications
Q5 2026
Regulatory Milestones: IND Filings & Vouchers
Solutions
Integrated Care: Lodonal™ + STARR Platform
Lodonal™ (JKB-122)
Our patented immune restoration therapy—oral, once-daily, non-addictive. Modulates immune pathways to restore balance without suppression. De-risked by 11,000+ patient database; no immunosuppression risk.
Attune Precision and STARR Digital Companian
A first-of-its-kind digital titration assistance platform delivering daily symptom and side-effect intelligence that proactively alerts clinicians when dosage adjustments are needed. Our AI-driven platform tracks, trends, and measures mental health in real time and, when indicated, suggests evidence-based stress regulation tools.
This unique approach of combining a bio pharmacological product with a real time digital health tool is groundbreaking and will ultimately enhance the success of the medication while building a self-help ecosystem for those who suffer.
ATTUNE BIOTECH
Regulatory & Access
Why Invest
Risk-Mitigated, High-Return Platform
"Scalable across $40-60B TAM in chronic inflammation markets, with a potential $300-450M in near-term voucher assets."
News
Our Latest Blogs
Attune Biotech Announces Strategic Federal Readiness Partnership with Callan JMB
Attune Biotech has entered into a strategic teaming agreement with Callan JMB Inc. (NASDAQ: CJMB), a nationally recognized integrative logistics and federal oversight company supporting BARDA, the Strategic National Stockpile, the Department of Defense, and the Department of Veterans Affairs.
Under the agreement, Callan JMB will serve as an independent third-party overseer of Attune’s manufacturing, quality assurance, regulatory compliance, and deployment operations—positioning Attune’s clinical and commercial pipeline for immediate federal readiness and emergency deployment. The partnership leverages Callan JMB’s existing government infrastructure to accelerate FDA audit readiness, BARDA compliance, and national stockpile integration.
This collaboration significantly advances Attune’s mission to deliver scalable, U.S.-manufactured therapies addressing critical unmet needs in immune restoration, pandemic preparedness, veteran health, and emergency response.
Read the full press release from Callan JMB to learn more about the partnership and its federal deployment implications.
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