The pain program COZY, which we are developing together with the Danish company Zyneyro, is currently in a very intensive phase. After establishing a joint COZY organization with Zyneyro at the beginning of the year, we have worked hard with preparations for the preclinical toxicology program in the peptide project COZY01 with the ambition to make this project be ready for clinical studies within a few years.
Preparations for the preclinical program
The preparations include selection of CDMO and CRO partners, i.e., the company that will manufacture the material for the toxicological study, respectively the company that will conduct the study. Choosing the right partners is an extensive task that has long-term and important implications. We have also worked to establish a Scientific Advisory Board for the COZY program. The Board’s main function will be to provide scientific review and advice. We are thus rapidly approaching the preclinical studies that will make COZY01 ready for the first study in humans.
Pain costs society huge amounts of money
Pain is one of the biggest challenges in healthcare. Severe chronic pain causes immense human suffering. The disease also leads to enormous costs for society. In the US alone, society’s total costs (healthcare costs and indirect costs such as sick leave and loss of production) for pain are estimated at USD 635 billion each year1. One factor that further complicates the picture is that conventional treatments (mainly anti-inflammatory drugs, antidepressants, anticonvulsant drugs, and opioids) are not specifically developed to treat chronic pain. 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. In the United States, an estimated 700,000 people have died due to opioid abuse in the past 20 years.
Great interest in new treatment options
Against this background, it is not difficult to understand that there is an enormous interest in new forms of treatment that do not have the disadvantages of today’s drugs. A good example of this is the independent evaluation of COZY01 that is ongoing at the National Institutes of Health (NIH) in the US, in a government-funded program (Preclinical Screening Platform for Pain, PSPP). 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.
Great interest from Big Pharma
That interest in next-generation pain relief is also great among Big Pharma companies was something Zyneyro’s CEO Peter Horn Møller and I experienced when we visited BIO2023 in Boston in early June. This year, the congress gathered 14,000 participants and 5,000 companies.
The primary purpose of our participation in Boston was to present our joint pain program COZY to Big Pharma companies. CombiGene has previously successfully outlicensed the epilepsy project CG01 to Spark Therapeutics in a deal with a potential value of USD 328.5 million. Our ambition is, of course, to make a corresponding journey with the pain program. Having said that, I would like to point out that deals of this kind are complex processes that take a long time to bring to a successful conclusion. The process begins by establishing a relationship with the potential companies, something that BIO2023 provided good opportunities for.
Positive meetings at BIO2023
The meetings we had with Big Pharma are of course surrounded by secrecy, which means that I cannot name the companies we met or give any specific details about our discussions. What I can say is that we met with several large pharmaceutical companies that are looking with interest at our pain program. We will have a continued dialogue about the pain program with those we met at BIO2023, and we have the ambition to over time expand the circle of potential partners.
Our focus for the second half of 2023 is now to continue the development of the very important pain program COZY. We will also continue our work to find additional projects to in-license to build an increasingly strong CombiGene.
1Relieving Pain in America: A Blueprint for Transforming Prevention, Care,
Education, and Research. Appendix C. The Economic Cost of Pain in the US.
Institute of Medicine (US) Committee on Advancing Pain Research, Care, and
Education. Washington (DC): National Academies Press (US); 2011