Beech Tree Labs has developed a novel drug development platform known as resonant molecular signaling (RMS), that aims to address a wide range of illnesses by restoring normal cellular communications and correcting various imbalances triggering problems. The company opted to go virtual for their next Phase 2, FDA-authorized clinical trial to evaluate the effect of Beech Tree’s BT-TML therapy targeting COVID-19 patients. Although many companies have moved to at least some provisional virtual or hybrid approach during the pandemic, Beech Tree Labs took another step toward a permanent move to virtual trials by partnering with Curavit Clinical Research for a fully decentralized trial. The Park City, Utah-based venture has an ambitious plan to disrupt the operation of clinical trials, accelerating timelines and reducing cost while maintaining if not improving quality with improved, patient-centric care.
Move to Decentralized or Virtual Trials more than ‘Flipping a Switch’
Recently, TrialSite writer Joseph Constance assessed the emerging virtual clinical trials landscape particularly in the midst of the COVID-19 pandemic. In an earlier piece, Constance suggested the move to decentralized or virtual studies was far more involved than “just flipping a switch.” It takes a whole shift in trial design, varying bundles of different technologies, and importantly, a new execution model along with deep expertise associated with clinical trials and compliance not to mention a special attention to patient-centric care.
The Beech Tree Study
Beech Tree plans a fully decentralized clinical trial powered by virtual trial design protocols, digital telehealth technologies, electronic patient reported outcomes (ePRO) and full web and contact center patient support, hence eliminating the need for in-person office visits.
This trial will evaluate Beech Tree’s BTL-TML therapy on mean duration and severity of COVID-19 in 40 outpatients aged 60 years or older with underlying conditions. This study will also assess the safety of BTL-TML over 10 days of treatment and an additional four days of follow-up.
The clinical trials sponsor selected Curavit because, according to Thomas Hatch, Director of Business Development at Beech Tree, “We chose Curavit because of their exclusive focus on designing and executing virtual trials. We needed a company with Curavit’s expertise in this important new discipline of clinical research in order to make this trial possible.”
According to disclosure at Clinicaltrials.gov, the study (NCT04522830) includes clinical research services firm Norwich Clinical Research Associates Ltd. who serve as study manager for the sponsor. The study will conclude October 30, 2020; its primary endpoint involves the mean duration and severity of the COVID-19 disease. The sponsor and collaborators will measure the delta in baseline in the physical component summary of the 36-Item Short Form Health Survey.
Virtual studies still include participating health institutions and principal investigators and in this case Utah’s Intermountain Health (Intermountain Clinical Research) supports this decentralized study led by Dr. Duane Harris.
Delivery Meets Virtual: Curavit
TrialSite’s Joe Constance penned after an interview with Curavit chief commercial officer Dave Hanaman, “For several years, we have been talking about how the confluence of data science, digital health technology, and telemedicine is a potentially revolutionary opportunity for clinical trials in terms of making them better, faster, and less expensive. Virtual trials are now starting to achieve these goals,” suggested Hanaman.
What does Curavit do?
As it turns out, the Park City, Utah-based startup represents one of the first vendors in a disruptive class known as pure-play virtual clinical trial organizations. With underlying new execution models, they bring together the world’s leading researchers and protocols, find participating health systems and enroll previously untapped and underserved patient populations, while embracing next generation technology, such as applied machine learning, health and social engagement data as well as telehealth, patient data platforms and mobile data platforms.
Curavit knows something about delivery. The founders, including Hanaman and CEO Joel Morse, built C3i, a leading global technology services company that offered clinical trial sponsors turnkey, worldwide support for mission-critical clinical study technologies. C3i was ultimately sold to Merck and then more recently to HCL Technologies.
By combining 1) best-of-breed technologies (cloud-based trial master file, ePRO, etc.), 2) access to patient data, 3) clinical trial process expertise, and 4) deep execution pedigree as evidenced by the development of a multinational clinical trials services support company the Curavit team are poised to accelerate the adoption of turkey, decentralized or virtual clinical trials.
About Beech Tree Labs (BTL)
Headquartered in Providence, RO, Beech Tree Labs (BTL) focuses on the discovery and early development of therapeutic agents that address a spectrum of unmet medical needs. The company has an extensive portfolio of patented formulations for products intended to treat such disorders as urinary incontinence, allergies, benign prostatic hypertrophy, anxiety, chronic obstructive pulmonary disease and herpesvirus infections. BTL has conducted over 15 FDA -authorized Phase 2 clinical trials and has out-licensed both technologies and products.
The company’s BTL-TML therapy has responded to COVID-19 and hence the ongoing clinical trial.
Duane Harris, MD, Intermountain Healthcare
Call to Action: TrialSite will monitor this Phase 2 decentralized clinical trial investigating BTL-TML targeting COVID-19 patients. With outcomes expected in the Fall positive results indicate significant opportunity for not only a novel potential treatment for COVID-19 but also the future of virtual trials.