EB-001T & EB-001A
Our pipeline is comprised of two BoNT/E product candidates. Our therapeutic product candidate, EB-001T, is being developed for the treatment of focal muscle pain, localized pain that can be caused by muscle contractions and spasms, for which there are currently no approved therapies. Our aesthetic product candidate, EB-001A, is being initially developed for glabellar frown lines and scar reduction following Mohs micrographic surgery, or Mohs surgery. Below is a table summarizing our development programs
(1) Phase 2 clinical trials conducted in two pain models: Mammoplasty (LANTERN-1) and Abdominoplasty (LANTERN-2)
Pipeline – EB-001T for Therapeutic Applications
Our therapeutic product candidate, EB-001T, is being developed for the treatment of focal muscle pain, which can occur as a result of surgical procedures or non-surgical muscle trauma. There are currently no approved therapies for focal muscle pain. There are more than 50 million surgical procedures performed in the United States each year. Based on our analysis, an estimated 11 million of these procedures are associated with significant post-operative focal muscle pain. In addition, we estimate that each year there are approximately 7 million reported non-surgical treatments for conditions with significant focal muscle pain, such as plantar fasciitis, sports hernia, shoulder pain and muscle strains or injuries.
EB-001T is designed to have a clinical profile with an onset of efficacy within 24 hours and duration of activity between two to four weeks. We believe this clinical profile could make EB-001T ideal for treating focal muscle pain compared to BoNT/A products, which typically have an onset of efficacy of approximately three to seven days and duration of activity of approximately three to four months. This long duration of activity can lead to long-term muscle immobilization resulting in muscle atrophy and muscle weakness. We believe that EB-001T has the potential to locally address a root cause of muscle pain in a way that marketed systemic therapies such as opioids, local anesthetics, muscle relaxants and non-steroidal anti-inflammatory drugs cannot, thus avoiding common central nervous system side effects.
We intend to evaluate EB-001T in two Phase 2 clinical trials in different pain models, mammoplasty and abdominoplasty, under our LANTERN (Long-Acting NeuroToxin-E Relief, Non-opioid) program. Our LANTERN-1 trial was a Phase 2 clinical trial in the mammoplasty model. We initiated a second Phase 2 clinical trial, LANTERN-2, in the abdominoplasty model in the second quarter of 2018.
Pipeline – EB-001A for Aesthetic Applications
Botulinum neurotoxins are commonly used in aesthetic applications. In 2016, there were approximately 15.4 million non-surgical cosmetic procedures performed in the United States, with approximately half of these procedures involving the injection of BoNT/A products. Injectable botulinum neurotoxin treatments are the single largest cosmetic procedure in the United States, accounting for $1.7 billion in sales in 2016. We believe EB-001A can potentially expand the aesthetic market by creating novel stand-alone and complementary applications that meet the demand for faster-acting neurotoxin products for situations like introduction to neurotoxins, touch-ups, time-sensitive events, and scar reduction.
EB-001A is a novel BoNT/E product formulation, different than EB-001T, that is specifically formulated for aesthetic applications and is designed to not be interchangeable with EB-001T. Like EB-001T, EB-001A is also designed to have a faster onset of efficacy and shorter duration of activity than currently approved BoNT/A products. We believe this differentiated clinical profile would provide quicker results, a desirable attribute in aesthetic applications. We have successfully completed a Phase 2a clinical trial in 42 patients with moderate to severe glabellar frown lines, in which we found that EB-001A had an onset of efficacy within 24 hours and duration of activity of up to 30 days. We intend to initiate a Phase 2b clinical trial in patients with moderate to severe glabellar frown lines in the fourth quarter of 2018.
In addition, we believe that EB-001A has the potential to reduce post-surgical scarring by decreasing tension at the excision site during wound closure by blocking muscle contraction. We are initially evaluating EB-001A for scar reduction following Mohs surgery. There were approximately 2 million Mohs surgeries conducted in 2016, more than 90% of which were located on the head and neck, and we believe there is strong interest in minimizing scar formation in these highly visible areas. We initiated a Phase 2a clinical trial in patients undergoing Mohs surgery in the first quarter of 2018 under our SHINE (Scar Healing Improvement with Neurotoxin-E) program.