PureTech Health plc (“PureTech Health” or the “Company”, LSE: PRTC), an advanced, clinical-stage biopharmaceutical company, today presented data for product candidate ALV-107 showing durable pain control throughout a 24-hour study period, lasting at least 12 times longer than lidocaine at a comparable dose (ALV-107 16 mg/kg, conventional lidocaine 16 mg/kg), in a validated preclinical model for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). ALV-107 utilizes the proprietary Alivio inflammation-targeting technology. The data were presented at the 2017 Drug Discovery and Therapy World Congress in Boston, Massachusetts.
“One of the greatest needs in urology is for a targeted therapy that can relieve the pain and inflammation of interstitial cystitis/bladder pain syndrome for extended periods of time,” said J. Curtis Nickel, Professor and CIHR Tier 1 Canada Research Chair in Urologic Pain and Inflammation at Queen’s University and Clinical Advisory Board member. “These promising, preclinical results suggest that ALV-107 may offer long-lasting relief for the many who suffer from this chronic and debilitating disease. I look forward to the acceleration of ALV-107 into the clinic and to exploring the full potential application of this targeted treatment approach.”
Pain levels, as measured by the mean nociceptive threshold, were statistically indistinguishable between the pain-free baseline and the ALV-107-treated group (n=8; at 2 hr, p=0.80; 4 hr, p=0.99; 24 hr, p=0.99). In contrast, the conventional lidocaine-treated group was only statistically indistinguishable from the pain-free baseline at 2 hours post-treatment (p=0.87). Furthermore, ALV-107 relieved pain at all studied time points post-therapy (vs. vehicle-only control: at 2 hr, p=0.002; 4 hr, p=0.002; 24 hr, p=0.0003). In contrast, the conventional lidocaine-treated group showed statistically significant pain relief only 2 hours post-treatment (p=0.03).
The Alivio technology is designed to adhere selectively to inflamed tissue and remain adhered to deliver the incorporated medication based on the levels of inflammation, potentially enabling improved properties for the drug while minimizing its exposure to healthy tissue and systemic side effects. Inflammation is a key feature of IC/BPS, which is a chronic condition affecting as many as 12 million people in the US and is characterized by recurring pelvic pain and frequent urination. Current treatments fail to control pain in many patients, particularly patients with Hunner’s lesions, which is estimated to affect between 5-10% of IC/BPS patients in the US.
To support this program in IC/BPS, PureTech Health has formed a Clinical Advisory Board consisting of key experts who have played a seminal role in the research and development of various medical therapies for several chronic pelvic pain conditions, including IC/BPS:
- J. Curtis Nickel, MD, FRCSC – Professor and CIHR Tier 1 Canada Research Chair in Urologic Pain and Inflammation at Queen’s University (Kingston, ON)
- Kenneth Peters, MD – Professor and Chairman of Urology at the Oakland University William Beaumont School of Medicine (Auburn Hills, MI)
- Robert M. Moldwin, MD, FACS – Director, Pelvic Pain Treatment Center at the Arthur Smith Institute for Urology and Associate Professor of Urology at the Hofstra Northwell School of Medicine
The Alivio technology was exclusively licensed from the lab of Jeff Karp, Ph.D., Associate Professor at Brigham and Women's Hospital (BWH), Harvard Medical School. In March of 2017, the Bill & Melinda Gates Foundation awarded a $1.2 million grant to Professor Jeff Karp’s Lab at BWH to support additional research on the technology.
About the Alivio Technology
The Alivio technology is a
proprietary hydrogel technology being developed for the targeted
treatment of chronic and acute inflammatory disorders. It is designed to
adhere to inflamed tissue and remain adhered to deliver incorporated
medication based on the levels of inflammation, potentially enabling
improved properties of the medication while minimizing exposure to
healthy tissue and systemic side effects. Alivio technology could
potentially be used with a variety of medications (e.g., small
molecules, peptides, proteins and nucleic acids) addressing dozens of
conditions where inflammation is a central part of the underlying
disease pathology, but where targeted and effective treatment options
are lacking.
The Alivio technology is being developed in collaboration with several of the world’s leading experts in biomaterials and immunology. Expert advisors include: Jeff Karp, Ph.D., Principal Investigator Karp Lab; Robert Langer, Sc.D., Co-Founder and Non-Executive Director at PureTech Health and David H. Koch Institute Professor at MIT; Michael B. Brenner, M.D., Chief of the Division of Rheumatology, Immunology and Allergy at BWH; Ulrich H. von Andrian, M.D., Ph.D., Mallinckrodt Professor of Immunopathology at Harvard Medical School; and Ralph Weissleder, M.D., Ph.D., Director of the Center for Systems Biology at Massachusetts General Hospital.
About PureTech Health
PureTech Health (PureTech Health plc,
PRTC.L) is an advanced, clinical-stage biopharmaceutical company
developing novel medicines targeting serious diseases that result from
dysfunctions in the immune, nervous, and gastro-intestinal systems by
intervening early and addressing the underlying pathophysiology of
disease. The Company is advancing a rich pipeline that includes two
pivotal or registration studies expected to read out in 2017, multiple
human proof-of-concept studies and a number of early clinical and
pre-clinical programs. PureTech Health’s growing research and
development pipeline has been developed in collaboration with some of
the world’s leading scientific experts, who along with PureTech's
experienced team and a stellar Board identify, analyze and advance very
selectively the opportunities the Company believes hold the most promise
for patients. This experienced and engaged team places PureTech Health
at the forefront of ground-breaking science and technological innovation
and leads the Company between and beyond existing disciplines. For more
information, visit www.puretechhealth.com
or connect with us on Twitter @puretechh.
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