Innovation1 Biotech
The Importance of Clinical Validation for Botanical Supplements
At our company, we believe rigorous clinical research is essential for developing truly effective botanical formulations. Unlike many supplement companies that rely solely on traditional usage or preliminary laboratory studies, we invest in comprehensive clinical trials to validate both the safety and efficacy of our products.
Our clinical research approach follows pharmaceutical-grade standards while acknowledging the unique characteristics of complex botanical formulations. This commitment to evidence-based development ensures our customers receive products with demonstrated benefits backed by scientific data.
Our clinical research approach follows pharmaceutical-grade standards while acknowledging the unique characteristics of complex botanical formulations. This commitment to evidence-based development ensures our customers receive products with demonstrated benefits backed by scientific data.
Tollovid/Nutravid Clinical Trial Program
Innovation 1 Bio’s assessment process combines proprietary computational Phase 2b/3 Clinical Trial Design
Our flagship product Tollovid (research name: NLC-V) underwent a rigorous clinical evaluation through a Phase 2b/3 randomized, double-blind, placebo-controlled clinical study registered with ClinicalTrials.gov (NCT05226767). withAt the core of our assessment process is our advanced computational platform that transforms metabolic data into scientific insights: At the core of our assessment process is our advanced computational platform that transforms metabolic data into scientific insights:
Study Design Details
- Study Population: Hospitalized COVID-19 patients ages 40-90 with confirmed SARS-CoV-2 infection
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Location: Shaare Zadek Medical Center
1.Patients <70kg: 2 capsules, 4 times daily (80mg daily)
2. Patients 70-100kg: 3 capsules, 4 times daily (120mg daily)
3. Patients >100kg: 4 capsules, 4 times daily (160mg daily) - Treatment Duration: 10 days
- Control Group: Standard of care plus placebo
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Primary Endpoints :
1. Time to clinical improvement (defined by NEWS2 score)
2. Time from hospitalization to discharge
Key Clinical Findings
The Phase 2b/3 clinical trial demonstrated significant benefits for patients receiving Tollovid compared to the placebo group:
Efficacy Results:
- Clinical Improvement: 100% of Tollovid-treated patients showed improvement on the NEWS2 scale compared to only 66% in the placebo group
- Hospital Duration: 7.2-day reduction in average hospital stay (10.6 days vs. 17.8 days)
- Mortality Benefit: 0% mortality in the Tollovid treatment group vs. 22% in the placebo group
- Mechanical Ventilation: 9% of Tollovid patients required mechanical ventilation compared to 33% in the placebo group
Biomarker Improvements
- Inflammatory Markers: Significant reductions in C-Reactive Protein (CRP), with Tollovid group showing 3.44 mg/L vs. 14.79 mg/L in placebo group at day 10
- Immune Function: Reduced IL-6 levels (24.6 vs. 36.23)
- Coagulation Markers: Marked improvement in D-dimer levels (2,755.8 vs. 29,554.00)
Safety Profile
- No significant hepatic or renal safety signals
- Well-tolerated with minimal side effects compared to other COVID-19 therapeutic agents
Additional Research: Long COVID Applications
Building on the success of the acute COVID-19 trial, we have expanded our research to investigate Tollovid’s potential benefits for patients with Long COVID/Post-Acute Sequelae of COVID-19 (PASC):
- Observational Studies: 80+ individual case studies monitoring symptoms over 30-90 day periods
- Symptom Improvements: Documented reductions in key PASC symptoms including fatigue, cognitive dysfunction, and cardiovascular abnormalities
- Upcoming Research: Randomized, observer-blinded, non-exposure control study evaluating Tollovid’s effects on immune system structure/function in Long COVID subjects
Future Clinical Research Directions
Our clinical research program continues to evolve with multiple initiatives underway:
- Expanded investigation of mechanism-based botanical interventions for viral persistence
- Evaluation of neutralizing antibody development and immune function normalization
- Additional studies on specific symptom clusters in post-viral conditions
These ongoing clinical studies represent our unwavering commitment to developing science-backed botanical formulations that truly improve health outcomes.