Attune Biotech: Pipeline Overview
A Focused Approach to Therapeutic Development
Attune Biotech’s clinical development program is centered on advancing a focused pipeline of therapeutic candidates, with our lead compound in active clinical trials. Our strategy involves utilizing various regulatory pathways to efficiently explore its potential across multiple indications. This section provides an overview of our current development efforts and the progress of our clinical programs
505(b)(2) Regulatory Pathway
A key aspect of Attune’s strategy is the use of the 505(b)(2) regulatory pathway. This pathway allows drug developers to rely on existing safety and efficacy data for a previously approved drug, which can:
- Streamline development requirements
- Reduce trial size and costs
- Accelerate the time to commercialization
This pathway is strategically important for Attune as it can potentially speed up the availability of Lodonal to patients across these various indications.
Targeting Multiple Therapeutic Areas
Clinical Pipeline
COVID Long Haul (EUA)
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:
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:
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:
The slide notes partnerships, suggesting collaborations to advance the development and commercialization of Lodonal for PTSD.
Cancer Adjunct Therapy
Supporting Patients Through Cancer Treatment
Indication:
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 Inflammation
Targeting the Root of Chronic Disease
Indication:
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:
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.
CLINICAL VALIDATION: IMPACT ACROSS MULTIPLE FRONTS
JKB-122 clinical trials provide compelling evidence of its therapeutic potential, demonstrating positive impact by modulating inflammation and improving outcomes in Long COVID, significantly benefiting military health challenges, addressing critical needs in HIV treatment, and showing promise as a supportive therapy in cancer care.
Demonstrating Clinical Efficacy Through Inflammation Modulation
Positive Impact on Key Health Outcomes
Attune Biotech is committed to providing transparent updates on our clinical progress. Our research demonstrates our lead compound’s significant potential to improve patient outcomes in key areas, largely by modulating the underlying inflammatory processes that contribute to various chronic conditions. These findings highlight the compound’s ability to target inflammation and restore immune balance, leading to improvements in challenging symptoms.
Long COVID Treatment
Addressing Inflammation and Restoring Immune Balance
Studies demonstrates significant potential in treating Long COVID by targeting the inflammation and immune dysregulation associated with the condition. Clinical studies have shown substantial reductions in key pro-inflammatory markers such as IL-6, TNF-α, and IL-1β, indicating a decrease in the body’s inflammatory response. Concurrently, treatment with Lodonal led to notable increases in anti-inflammatory markers, including IL-10, TGF-β, and IL-4, suggesting a shift towards a more balanced immune state. Furthermore, Lodonal treatment resulted in increases in crucial immune cells, specifically CD4+ T cells, CD8+ T cells, NK cells, and B cells, demonstrating a positive modulation of the immune system’s cellular components. Specifically, significant reductions were observed in pro-inflammatory markers, including IL-6 (with a reduction of 41.2 pg/mL), TNF-α (reduction of 8.9 pg/mL), and IL-1β (reduction of 7.2 pg/mL). Concurrently, increases were seen in anti-inflammatory markers, such as IL-10 (increase of 12.3 pg/mL), TGF-β (increase of 14.8 pg/mL), and IL-4 (increase of 6.9 pg/mL). Increases were also observed in CD4+ T cells (increase of 11.2 cells/μL), CD8+ T cells (increase of 14.7 cells/μL), NK cells (increase of 18.2 cells/μL), and B cells (increase of 12.1 cells/μL). These findings indicate that Lodonal can help to modulate the immune response and restore immune balance in individuals suffering from Long COVID, a condition characterized by persistent and often debilitating chronic inflammation.
Military Health Challenges: Outcomes in DoD & VA Trial
Military Health Challenges: Outcomes in DoD & VA Trials
Clinical trials in Department of Defense (DoD) and Veterans Affairs (VA) populations have demonstrated significant positive outcomes across several key health metrics. These trials highlight our therapy’s potential to address the complex health challenges, including chronic pain and PTSD, faced by service members and veterans, where inflammation and immune dysregulation play a major role. Notable improvements include a 58% reduction in chronic pain, a 62% improvement in PTSD symptoms, a 43% decrease in opioid use, a 62% increase in deployment readiness, and a 72% enhancement in overall quality of life.
HIV Treatment
Addressing Unmet Needs in Treatment-Resistant HIV
Studies have shown promise in addressing the critical gap in care for individuals with treatment-resistant HIV, a condition often marked by persistent inflammation and immune activation. Clinical improvements include a 68% reduction in chronic inflammation and a 72% decrease in inflammatory markers, along with an 85% increase in CD4+ count and a 76% improvement in immune response.
Cancer Adjunct Therapy
Promising Results in Cancer Adjunct Treatment
Key trial results in cancer adjunct therapy have shown positive outcomes, suggesting that our compound may play a role in modulating the immune response in cancer treatment. Results include a 74% survival rate (+4.2 months) in breast cancer, a 77% progression-free survival (PFS) (+3.8 months) in melanoma, and a 71% completion rate (+38%) in lung cancer trials