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About our project

A new way to take peptide medicine – through a film inside the cheek

Current challenges

Why we need a better way

Many modern medicines are made of so-called peptides A bunch of amino acids (the individual building blocks of proteins) combined together – small proteins that can have a therapeutic benefit. But there are challenges with delivering those therapies in the body:
  • Few peptide-therapies have been turned into tablets or capsules. However, swallowing them as tablets/capsules often does not work well, because our stomach and gut break them down, causing problems dosage control and how much of the drug actually reaches the bloodstream to do its job. They also are not absorbed well through the gut wall, and interact with food and drink.
  • Injections work, but they can be painful, inconvenient, and discouraging to take regularly.
That’s why we need a solution that is easy, safe, and effective.

Our solution

The BUCCAL-PEP film

To overcome these challenges in oral delivery, including interactions with food and drink or being broken down by the liver, the BUCCAL-PEP consortium is developing a multifunctional, thin film that sticks to the inside of the cheek. This  allows – for the first time – delivery of peptide-analogue therapies through the cheek, so-called buccal delivery. Through unique integration of an absorption booster with the peptide medicine, the film enables peptides to diffuse across the cheek.

Understanding the film

How will the BUCCAL-PEP film work?

The BUCCAL-PEP film will be placed inside the cheek and work in three steps:

1

The sticky layer releases an absorption booster that helps the cheek absorb peptides.

2

Small proteins (peptides) can now travel across the cheek surface to reach the blood.

3

The film dissolves after the proteins are taken up into the blood stream.

By the end of the project, we aim to have a ready-to-test film that can move into clinical trials. This could mark the start of a new generation of peptide therapies that are safer, easier, and better for patients.

Our work

How is the project structured?

In this project, the consortium will design, select and manufacture a lead product, with Type 2 Diabetes as showcase indication. The film will be validated for performance in in vivo large animal studies. Additionally, a Health Technology Assessment will be performed to support the development of an evidence-based value proposition as well as  a commercialisation strategy. The final deliverable of the project is a film that is pre-clinically validated and ready for clinical trials in the desired showcase indication.

The work has been structured in different work packages:

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In-cheek delivery of peptide-analogue therapies

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Funding statement

This project has received funding from the European Union’s Horizon Europe research and innovation programme under grant number 101091765. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union or European Innovation Council. Neither the European Union nor the granting authority can be held responsible for them.

Susie Birney

Patient Advocate

Susie lives in Dublin and volunteers her time to help advocate for others who live with obesity and Type 2 Diabetes. Most recently Susie was involved with Diabetes Ireland in the drafting of the “Talking about Diabetes : Language Matters” Guide. Addressing stigma for either Diabetes or Obesity which Susie has lived experience of,  is high on the list of her priorities and being involved in advisory boards is one example of how to do this by being involved throughout the research process from beginning to end.

Maura Murphy

Retired Civil Servant but currently Voluntary Secretary at ICPO the Irish Coalition for People Living with Obesity

Maura thinks it is important to treat the patient holistically. Over the years, she has been visiting several hospitals for different conditions, and these silos can be exhausting. She is passionate about learning about obesity since she discovered that it is a disease in 2019. Prior to that, her self-blame and stigma held her back. She has learned that obesity is a gateway to other diseases, and she knows this firsthand because she lives with Type 2 Diabetes, Hypertension, Gout, Fluid Retention, and Osteoarthritis. She attends a Chronic Disease Clinic in Ballina every six months, which has thankfully eliminated the silo appointments to three different hospitals and their various departments.

Mary Frances White

Social Care Worker within the community care system/ committee & patient representative for ICPO

Mary Frances is married with one adult child. She has worked for many years as a Social Care worker within Adult services for those with intellectual disabilities. She is SAM’s trained as she dispenses medication on a daily basis (SAM’s = Safe Administering of Medication).

She is also one of the first committee members and a patient representative for an ICPO. They give talks to medical students of many disciplines regarding respect and dignity for people living with obesity. They also hold weekly support meetings and face-to-face meetings when possible. The subject of medications that are becoming available for those who are living with obesity is very topical at present.

Ken Tait

Psychotherapist & International Diabetes Advocate

As a psychotherapist, Ken helps people navigate emotional problems. As a Diabetes Advocate, he supports individuals living with diabetes and advocates for the help and support they need. He serves on many local diabetes boards and gives talks both nationally and internationally to help people and healthcare professionals understand what living with type 2 diabetes is like.

The reason that he joined BUCCAL-PEP was that he likes to keep abreast of what is happening for people with diabetes and how they can manage their diabetes Additionally, he recognizes that some people dislike needles, and this BUCCAL-PEP approach could provide an alternative to help them.

Ken Tait

Psychotherapist & International Diabetes Advocate

As a psychotherapist, Ken helps people navigate emotional problems. As a Diabetes Advocate, he supports individuals living with diabetes and advocates for the help and support they need. He serves on many local diabetes boards and gives talks both nationally and internationally to help people and healthcare professionals understand what living with type 2 diabetes is like.

The reason that he joined BUCCAL-PEP was that he likes to keep abreast of what is happening for people with diabetes and how they can manage their diabetes Additionally, he recognizes that some people dislike needles, and this BUCCAL-PEP approach could provide an alternative to help them.

Javier O. Morales, Ph.D.

Biosketch

Dr. Javier O. Morales is an Associate Professor at the University of Chile, specializing in pharmaceutical science and technology. He heads the Center of New Drugs for Hypertension (CENDHY) and is an Associate Researcher in the Advanced Center for Chronic Diseases (ACCDiS). With a Ph.D. from The University of Texas at Austin, he focuses on innovative drug delivery systems, particularly for peptides, proteins, and poorly water-soluble drugs. His research explores nanoencapsulation and alternative routes of administration. Dr. Morales has a keen interest in buccal absorption and 2D/3D printing for drug delivery. He joined BUCCAL-PEP’s SAB to advance less invasive diabetes treatments and explore synergies with his own research.

Giovanni Traverso, MB, BChir, PhD

MIT and Harvard

Prof. Giovanni Traverso is the Director of the Laboratory for Translational Engineering at MIT and Harvard, an Associate Professor of Mechanical Engineering at MIT, an Associate Physician in Gastroenterology at Brigham and Women’s Hospital, Harvard Medical School, and an Associate Member of the Broad Institute. He received his undergraduate and medical degrees from Cambridge and a PhD from Johns Hopkins, where he pioneered non-invasive cancer detection. His postdoctoral research at MIT focused on advanced drug delivery and gastrointestinal sensing. His current work drives next-generation drug delivery systems and ingestible devices for physiological monitoring.

Prof. Ljiljana Fruk

University of Cambridge

Prof. Ljiljana Fruk is a Professor of Bionano Engineering at the Department of Chemical Engineering and Biotechnology at University of Cambridge.  Her research encompasses the design and development of nanoscale materials for biomedical applications, including design of drug nanocarriers for solid tumours and biosensors for early detection of cancer. She is particularly interested in development of nature-inspired structures, and has also made significant contributions to development of hybrid bio-nano materials and their application in photocatalysis and sustainable manufacturing. She is one of the co-founders of Senesys Bio, Cambridge spinout developing therapeutic formulations for senescent cell removal. Prof Fruk is an active science popularizer, art-science curator, and the co-author of the field-establishing Molecular Aesthetics book (MIT Press 2013), and the first textbook on Bionanotechnology (Cambridge University Press 2021).

Dr. Eva Roblegg

University of Graz

Dr. Eva Roblegg is a full professor at the University of Graz, specializing in pharmaceutical technology and biopharmacy. She leads the Drug Delivery and Advanced Manufacturing group and focuses on the development of nano drug delivery systems (nanoDDS) for the treatment of oral diseases, such as oral mucositis. To better understand the relationship between nanoDDS and buccal/sublingual tissues, her group has developed in vitro cell and tissue models that mimic healthy and inflamed human oral mucosa. Eva Roblegg works closely with the Research Center Pharmaceutical Engineering, a center of excellence in Graz, Austria, where she is involved in advanced technologies for the continuous manufacturing and conversion of (nano-)drug delivery systems into final dosage forms. Given her research interest in this area and the opportunity to create further synergies with her own research, she has joined BUCCAL-PEP’s SAB.

Dr. Andrew Muddle

MedPharm

Dr. Andrew Muddle, founder and former CEO of MedPharm, brings over 30 years of pharmaceutical industry experience in drug delivery. He played a pivotal role in PowderJect Pharmaceuticals plc’s early development and IPO, and his career includes positions at Elan Corporation, Ethical Pharmaceuticals Ltd (U.K.), Controlled Therapeutics (Scotland), and Ciba-Geigy (now Novartis). Dr. Muddle excels in managing projects to commercialization, specializing in transdermal and topical products. He joined BUCCAL-PEP due to the challenge of oral peptide delivery.