BTL-slo addresses a broad range of respiratory diseases such as chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF). According to WHO, 65 million people have moderate to severe COPD with 3 million deaths annually. Approximately five million people worldwide suffer from IPF with a 50 percent mortality rate within three years of diagnosis. The incidence of these disorders is steadily increasing.
Market Impact: Beech Tree Labs is focusing its efforts on BTL-slo for the treatment of COPD, a market currently estimated to be $5 billion in the United States and $11 billion worldwide. Some observers estimate that COPD is grossly under-diagnosed and that the market would grow significantly if improved therapeutic agents with less severe side effects were introduced as side effects prevent many COPD patients from using currently approved drugs.
Safety: Dose levels of up to 5,000X the anticipated human dose of the streptolysin O component have been administered daily by tail vein injection in rats for seven days without adverse effects. BTL-stcf, microdose DNA, has been evaluated in three FDA-authorized clinical trials for various respiratory conditions, including COPD, with no serious adverse effects reported.
Efficacy: The anti-scarring properties of BTL-slo are evident from genomic, cellular, tissue, pre-clinical animal studies.
Mechanism of Action: Unlike many drugs in development for COPD, Beech Tree Lab’s product candidate is new and innovative, not simply a me-too product. Our product may consist of BTL-slo (Streptolysin O, a 60kD peptide and one of a group of filterable hemolysins derived from Group A beta-hemolytic streptococci) as a single agent or used together with BTL-stcf. This combination provides a new treatment paradigm for a wide range of debilitating pulmonary diseases.
Intellectual Property: A U.S. patent has been issued for treatment of COPD. Applications of the foreign counterparts of this patent have been filed. Additional new patents are being submitted and prosecuted by Beech Tree for the treatment of adhesions, lung diseases, and various other scar-associated indications.
Our experiments, studies, and case reports provide compelling evidence of significant efficacy of BTL-slo/stcf in treating lung diseases like COPD, as well as likely mechanism of action through which described clinical outcomes are achieved.