Bonti Announces Start of LANTERN-2 Phase 2 Clinical Trial Evaluating EB-001T in Treating Focal Muscle Pain
- Category: Proteins and Peptides
- Published on Wednesday, 09 May 2018 17:48
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Follows Completion of LANTERN-1 Clinical Trial
NEWPORT BEACH, CA, USA I May 09, 2018 I Bonti, Inc., an innovative clinical-stage biotechnology company focused on the development and commercialization of novel, fast-acting neurotoxin products for therapeutic and aesthetic applications, today announced it has initiated dosing in its LANTERN-2 clinical trial, a Phase 2 clinical trial under Bonti’s LANTERN (Long-Acting NeuroToxin-E Relief, Non-opioid) clinical program aimed at treating focal muscle pain and reducing use of rescue medications, including opioids. LANTERN-2 is a randomized, placebo-controlled, ascending dose, double-blind clinical trial to evaluate the safety and efficacy of intramuscular (IM) injections of Bonti’s therapeutic product candidate, EB-001T, in subjects undergoing elective abdominoplasty (tummy tuck) surgery. EB-001, the active ingredient in both EB-001T and Bonti’s aesthetic product candidate, EB-001A, is derived from botulinum neurotoxin serotype E (BoNT/E) and is designed to have a differentiated clinical profile with a faster onset of efficacy (within 24 hours) and a shorter duration of activity (2 to 4 weeks) than botulinum neurotoxin serotype A (BoNT/A) products. EB-001T and EB-001A are being developed to address areas of unmet therapeutic and aesthetic need.
Dose selection for the LANTERN-2 trial was based on favorable safety results from the recently completed LANTERN-1 clinical trial, which was Bonti’s first trial in the LANTERN program. LANTERN-1 was a Phase 2 clinical trial evaluating EB-001T in subjects undergoing elective mammoplasty (breast augmentation), in which EB-001T showed favorable safety in a wide dose range and was well tolerated, and in which the maximum tolerated dose was not reached. The highest EB-001T dose tested in LANTERN-1 was 8-fold higher than the maximal dose in Bonti’s previously successful clinical study in the glabellar frown lines model. LANTERN-1 therefore helped establish a safe dose range for use in larger muscles that will be injected to treat focal muscle pain in LANTERN-2.
The LANTERN-2 trial comprises a single intra-operative administration of EB-001T IM injection into the rectus abdominis (RA) muscle in subjects undergoing abdominoplasty with plication of the RA sheath. The primary endpoint in this trial will be reduction of post-operative pain at rest as measured by the Numeric Pain Rating Scale (NPRS) over the first 96 hours. Secondary endpoints include NPRS during activity and patient use of rescue medications, including opioids, to address unrelieved pain. Bonti expects topline results of this trial in the fourth quarter of 2018.
”We are excited about the key findings from our LANTERN-1 clinical trial, as they allow us to expand our LANTERN clinical program into a well-established model of post-operative pain,” said Fauad Hasan, CEO and co-founder at Bonti. “EB-001T has the potential to be an effective locally acting pain treatment that addresses a root cause of pain by decreasing muscle hyperactivity and spasms following surgery and in non-surgical cases. EB-001T may help healthcare providers and patients reduce the use of opioids, with their associated side effects and risk of addiction. We continue to press ahead toward the objective of establishing EB-001T as a long-acting, non-opioid solution for the treatment of focal muscle pain.”
“As I continuously strive to optimize outcomes for my abdominoplasty and other surgery patients, Bonti’s EB-001T could potentially be an appealing multi-modal pain management option to provide effective pain relief following surgery,” commented Dr. Alan Matarasso, Clinical Professor of Surgery at PS Hofstra University – Northwell Health Systems, renowned aesthetic plastic surgeon in practice in Manhattan and currently a Bonti Medical Advisor. “Abdominoplasty is a very painful procedure, where the potential source of post-operative pain is muscle trauma due to plication of the rectus sheath and tightening of the muscular abdominal wall. Helping my patients recover faster, better and with potentially less opioid use following their abdominoplasties are significant goals which EB-001T, with its fast onset of effect, may help me achieve successfully.”
Bonti estimates that there are approximately 11 million surgical procedures and 7 million non-surgical treatments annually in the U.S. that are associated with significant focal muscle pain. Focal muscle pain is localized pain that can be caused by muscle contractions and spasms, which can occur as a result of surgical procedures or non-surgical muscle trauma. Current pain relief medications such as opioids, local anesthetics, nonsteroidal anti-inflammatory drugs and acetaminophen are not specifically indicated for focal muscle pain and may target pain from a systemic point of view, causing common central nervous system side effects.
LANTERN Clinical Program
The LANTERN (Long-Acting NeuroToxin-E Relief, Non-opioid) clinical program’s key objective is to provide a basis for a broad label for EB-001T for the treatment of focal muscle pain, an indication with no currently approved therapies.
Bonti is developing a first-in-class pipeline of proprietary product candidates based on EB-001, which is derived from BoNT/E. BoNT/E has a validated mechanism of action similar to that of currently approved products derived from BoNT/A, but, based on preclinical and clinical data, BoNT/E has a faster onset of efficacy (within 24 hours) and a shorter duration of activity (2 to 4 weeks) compared to BoNT/A products, which have an onset of efficacy of approximately 3 to 7 days and a duration of activity of approximately 3 to 4 months. Based on this differentiated clinical profile, Bonti’s therapeutic product candidate, EB-001T, is being developed for the treatment of focal muscle pain, and Bonti’s aesthetic product candidate, EB-001A, is being initially developed for glabellar frown lines and for scar reduction following Mohs surgery.
Bonti, based in Newport Beach, CA, is an innovative clinical-stage biotechnology company focused on the development and commercialization of novel, fast-acting neurotoxin products for therapeutic and aesthetic applications. The company was founded and is led by executives with extensive experience obtained at Allergan plc with botulinum neurotoxin products from discovery, clinical, supply chain, regulatory and commercialization perspectives. By turning the science of neurotoxins into beneficial patient and healthcare provider solutions, Bonti seeks to improve lives by successfully addressing key unmet needs in markets with significant addressable opportunities.
For more information, please visit http://bonti.com.