PureTech Announces Publication of Collaborator Research Demonstrating that PureTech’s Glyph™ Platform Improves Oral Absorption of Buprenorphine (a Clinically Validated Opioid Replacement Therapy)

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BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to the discovery, development and commercialization of highly differentiated drugs for diseases devastating, today announced the publication of preclinical proof of concept demonstrating that PureTech’s Glyph platform can improve the oral bioavailability of buprenorphine (BUP), a clinically validated opioid replacement therapy, further expanding the range of drug classes clinically validated and suitable for Glyph technology. The newspaper, published in Frontiers in pharmacology1, applies Glyph technology to BUP, a potent analgesic widely used for severe pain management and opioid replacement therapy, but not currently available in an ingestible oral dosage form due to low oral bioavailability . In preclinical models, researchers observed up to 20-fold increases in bioavailability and statistically significant increases in lymph transport.

“The therapeutic potential of buprenorphine is potentially limited by a lack of systemic exposure after administration of a capsule formulation that can be swallowed. The ability to develop an oral buprenorphine product with high bioavailability could potentially address a range of important unmet clinical needs and provide greater patient convenience,” said Christopher Porter, Ph.D., director of the Monash Institute of Pharmaceutical Sciences at Monash University in Melbourne, lead study author and PureTech collaborator. “The results of this study further amplify the breadth of Glyph’s delivery technology and its ability to use new chemistries and molecules for versatile applications.”

Glyph technology generates novel orally-dosed prodrugs by reversibly linking small molecule drugs to dietary fat molecules. This linkage is designed to channel drugs directly into the systemic circulation via the lymphatic system, thereby bypassing first-pass hepatic metabolism that typically degrades many drugs and reduces their systemic exposure. Glyph technology is being developed to be applicable to a range of clinically validated, low bioavailability drugs, including neuromodulators such as allopregnanolone (with the clinical-stage therapeutic candidate, LYT-300) or immune modulators that could directly target the mesenteric lymph nodes.

“The research serves as another proof of concept for our Glyph platform and how this innovative drug delivery technology can be applied to a range of diseases,” said Joseph Bolen, Ph.D., Chief Scientific Officer of PureTech. “This latest research reinforces our commitment to leverage validated biology to accelerate development of the Glyph portfolio to improve oral bioavailability and/or lymphatic targeting of proven drugs.

PureTech’s LYT-300 is the first therapeutic candidate generated by the Glyph technology platform to enter the clinic. LYT-300 is an oral formulation of the clinically validated neurosteroid allopregnanolone, being developed for the potential treatment of a range of neurological and neuropsychological conditions. An injectable formulation of allopregnanolone is approved by the United States Food and Drug Administration (FDA) for the treatment of postpartum depression as a 60-hour infusion, a method of administration that has inherent limitations. Synthetic oral analogs of allopregnanolone have had variable clinical success, and their comparable activity with natural allopregnanolone remains to be established.

About the Glyph™ Technology Platform

Glyph Technology is PureTech’s lymphatic-targeting synthetic chemical platform designed to utilize the lymphatic system’s natural lipid absorption and transport process to enable oral delivery of therapeutics. Glyph technology reversibly binds small molecule drugs to dietary fat molecules, creating a new prodrug. The bound fat molecule redirects the drug’s normal pathway into systemic circulation, bypassing the liver and instead traveling from the gut to the lymphatic vessels that normally process dietary fat. PureTech believes this technology has the potential to (1) enable direct modulation of the immune system via drug targets found in the mesenteric lymph nodes and (2) provide a broadly applicable way to improve the bioavailability of orally administered drugs that would otherwise be reduced by first-pass hepatic metabolism. PureTech leverages validated biology to accelerate development of a Glyph portfolio, prioritizing highly characterized drugs to be enhanced with Glyph technology based on potential value unlocked by improving their oral bioavailability or lymphatic targeting. PureTech’s Glyph lead therapeutic candidate, LYT-300 (oral allopregnanolone), is being evaluated in a Phase 1 study, with results expected in the second half of 2022. PureTech has been granted an exclusive license to the platform Glyph technology, which is based on the pioneering research of Christopher Porter, Ph.D., and his research group at Monash University’s Monash Institute of Pharmaceutical Sciences. The Porter Research Group and collaborators have published research in Frontiers in pharmacology, Natural metabolism and the Controlled Release Diary supporting the ability of the Glyph platform to directly target the lymphatic system with a variety of therapies.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to the discovery, development and commercialization of highly differentiated drugs for devastating diseases, including inflammatory, fibrotic and immunological conditions, incurable cancers, lymphatic and gastrointestinal diseases and neurological and neuropsychological disorders, among others. The company has created a broad and deep pipeline through the expertise of its experienced research and development team and its vast network of scientists, clinicians and industry leaders. This pipeline, which is progressing both internally and through PureTech’s founded entities, includes 25 therapeutic products and therapeutic candidates, two of which have received both U.S. FDA clearance and European marketing clearance. , as of the date of the last half-yearly report filed by PureTech. and the corresponding Form 6-K. All underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the company’s unique insights into the biology of the brain, immunity and gut, or BIG, systems and the interface between these systems, called the BIG Axis.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Caution Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that do not relate to historical facts should be considered as forward-looking statements. , including, without limitation, statements relating to expectations regarding the potential therapeutic benefits of our therapeutic candidates or platform technologies, our expectations regarding the Glyph platform and future prospects, development plans and strategies for Pure Tech. Forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but without limitation, these risks, uncertainties and other important factors described under “Risk Factors” in our Annual Report on Form 20-F for the fiscal year ended December 31, 2020 filed with the SEC and in our other regulatory documents. These forward-looking statements are based on assumptions about the Company’s present and future business strategies and the environment in which it will operate in the future. Each forward-looking statement speaks only as of the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

[1] Hu, L., Quach, T., Han, S., Lim, SF, Senyschyn, D., Trevaskis, NL, Simpson, JS, Porter, CJH Self-immolative glyceride mimetic prodrugs promote lymph transport, avoid lymphatic first-pass metabolism and improve bioavailability. Angelw. Chem. Ed. (2016) 55, 13700-13705.

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