Beech Tree Labs (BTL) conducted an FDA-authorized clinical trial to evaluate the effect of BTL-tml on duration and severity of COVID-19 in outpatients with underlying conditions. The study also assessed the safety of BTL-tml as well as its efficacy. The trial has completed, safety proven, with an insufficient number of subjects to attain statistical significance. A larger trial is being considered.
Prior to initiating the COVID-19 clinical trial, using the same protocol BTL-tml was shown to be safe and effective in an FDA-authorized clinical trial targeting recurrent oral herpes infection. Administered sublingually, BTL-tml led to rapid improvement of herpesvirus symptoms without adverse effects. In fact, patients in the placebo group reported three times the number of adverse events than did those in the treatment arm of the study. Anecdotal evidence also suggests that BTL-tml is active against other viral infections, including SARS-CoV-2, Influenza, and Ebola.
BTL-tml is not currently available for patients with a Sars-CoV-2 infection. The Company is interested in licensing this product candidate to a larger company for further evaluation and marketing.
To learn more about this study:
Visit clinicaltrials.gov, the U.S. National Library of Medicine database of clinical studies conducted around the world. ClinicalTrials.gov identifier (NCT number): NCT04522830
In vitro studies show BTL-tml to be a potent inhibitor of viral replication in several cell line systems. In addition, genomic testing indicates this agent down-regulates important pro-inflammatory genes such as those coding for INF-alpha, IL-1, and GM-CSF. Overall, BTL-tml dampens the cytokine storm that leads to symptoms of infection while simultaneously inhibiting viral propagation.
Please see the peer-reviewed mechanism-of-action information relating to the use of immunomodulatory agents to alleviate COVID-19 symptoms. https://journals.asm.org/doi/10.1128/mSphere.00288-20
Beech Tree has completed two FDA-authorized randomized, placebo-controlled Phase 2 clinical trials to evaluate BTL-tml for recurrent oral herpesvirus infection. No serious adverse effects were observed in the combined 85 patients exposed to BTL-tml. Results are published in a peer-reviewed scientific journal. https://europepmc.org/article/PMC/PMC8841908
For additional safety information, please see BTL-TML Safety Facts. https://beechtreelabs.com/covid19/btl-tml-safety