In early 2023, CombiGene and the Danish company Zyneyro initiated a collaboration to jointly develop the pain program COZY. The program consists of a peptide treatment and a gene therapy that are both based on the same unique mechanism of action. The goal of the project is to develop effective treatments for severe chronic pain, a common and often difficult-to-treat condition. Both the peptide and the gene therapy are being developed for the treatment of severe chronic pain conditions where the gene therapy is reserved for patients where the possibilities for spontaneous reduction of the pain are considered excluded or unlikely.

Ingeneious contacted Alvar Grönberg, Senior Program Director at CombiGene, to see how the work is progressing.

CombiGene and Zyneyro have now been working together since the beginning of the year. Can you briefly describe what you have focused on and how far the work has come?

“Let me first say that I find the COZY program extremely exciting. Chronic pain is one of the biggest challenges facing today’s healthcare and to be involved in developing a new and effective treatment without the side effects that today’s treatment options often give rise to is immensely stimulating.”

“Together with our colleagues at Zyneyro, we have since we started the collaboration in January this year focused on the upcoming pivotal preclinical toxicology program within the peptide project COZY01. We are currently deeply involved in the extensive preparations for this very important part of the project. The work consists, among other things, of selecting the company that will produce material for the toxicological study program and also the company that will carry out the studies. Choosing the right partner is an extensive task that has long-term and important consequences, and we put a lot of effort into finding the very best partners.”

“In addition to preparing the toxicology program, we have also worked on a number of preparatory activities for the next step in the program run by the National Institutes of Health (NIH) in the US. The program is called Preclinical Screening Platform for Pain (PSPP) and aims to find pain relief options that are not addictive or result in tolerance development. COZY01 has passed the first level of three and has been selected to move on to the next level where the substance will be tested in different pain models.”

How would you describe the need for new treatments for chronic pain?

“The need is absolutely enormous. Between six and eight percent of the world’s population is estimated to suffer from severe chronic pain. At the same time, current treatments are associated with a number of shortcomings. The conventional treatment options consist mainly of anti-inflammatory drugs, anti-depressants, anti-convulsants and opioids (a group of substances with a morphine-like mechanism of action). The problem is that these treatments are not specifically developed to treat chronic pain and that the pain relief that is achieved often has a number of debilitating side effects such as substance abuse problems, depression, anxiety, fatigue, reduced physical and mental ability. If we succeed with the COZY program, we could help a very large number of people to a better life.”

The fact that so many people are affected by chronic pain must lead to great costs for society.

“That’s absolutely right. Chronic pain is the single most costly disease for society. In the US alone, the cost to society is estimated at an unimaginable USD 635 billion a year –significantly more than the costs of cardiovascular disease, which amounts to USD 309 billion, and cancer, which costs American society USD 243 billion annually.1”

What is the near future for the COZY program?

“More of the same, you could say. We continue to work on the preparations for the pivotal preclinical toxicology program. In parallel, we will also continue to work on developing the final gene therapy vector and preparing for the next steps within PSPP.”