PureTech Health Presents Data Supporting Treatment Approach for Interstitial Cystitis/Bladder Pain Syndrome Based on Novel Alivio Inflammation-Targeting Technology

Clinical Advisory Board formed as product candidate ALV-107 advanced for the treatment of Interstitial Cystitis/Bladder Pain Syndrome

BOSTON--()--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.

Forward Looking Statement
This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

PureTech Health
Allison Mead, +1 617-651-3156
amead@puretechhealth.com
or
FTI Consulting
Ben Atwell or Rob Winder, +44 (0) 20 3727 1000

Release Summary

PureTech Health, an advanced, clinical-stage biopharmaceutical company, today presented data for product candidate ALV-107.

Contacts

PureTech Health
Allison Mead, +1 617-651-3156
amead@puretechhealth.com
or
FTI Consulting
Ben Atwell or Rob Winder, +44 (0) 20 3727 1000