CombiGene’s pain programme takes important steps forward
CombiGene is moving towards the toxicological studies in the COZY01 pain project, which is being conducted in collaboration with the Danish biotech company Zyneyro.
– We will continue to work methodically to complete the preclinical studies needed in order to be able to start the preclinical toxicology programme, says CombiGene’s CEO Peter Ekolind.
At the beginning of 2023, the gene therapy company CombiGene entered into a collaboration with the Danish biotech company Zyneyro for the development of more effective treatments for severe chronic pain conditions. The joint pipeline consists of the peptide treatment COZY01 and the gene therapy treatment COZY02 – both with the goal of becoming effective therapies for severe chronic pain.
New biological mechanism of action
The projects are based on a new biological mechanism of action that is expected to have fewer debilitating side effects than today’s pain treatments, according to CombiGene. Both COZY01 and COZY02 target the target protein PICK1 (Protein Interacting with C Kinase). The results from CombiGene’s studies in human peripheral tissue confirm that PICK1 is expressed in the tissue that the company intends to treat according to the company’s latest newsletter.
– This marks an important milestone for both COZY01 and COZY02 and the project continues according to plan, CEO Peter Ekolind says in the company’s latest newsletter.
Development of the pain project is progressing
In 2023, progress was made in the COZY1 project in particular. Among other things, the contract manufacturer (CDMO) AmbioPharm was hired for the manufacturing of COZY01, while Charles River Laboratories was appointed as a contract research partner for the pre-clinical toxicology studies to be conducted.
Additionally, the company decided to focus on patients with pain associated with Herpes Zoster (shingles) in the upcoming clinical study. The goal is to demonstrate Proof-of-Concept in shingles and then continue the development of diabetic neuropathy, one of the most common chronic complications in diabetes.
At the end of 2023, the COZY01 project received EUR 0.7 million (SEK 8.6 million) in funding from Eurostars, a European collaboration to support small and medium-sized innovative companies.
Insights for the toxicological studies
In its latest newsletter, CombiGene announced that they have now made further progress as they have produced data on plasma stability, plasma protein binding and liver metabolism for COZY01. The pharmacokinetic profile of the candidate was mainly studied by subcutaneous injections, which is the planned route of administration for the product.
The preclinical studies were conducted on three animal species – mouse, pig and rat. The results from the studies in mice and pigs showed a similar uptake, while the results for rats differed. Therefore, the focus will now be on mice and pigs in the upcoming toxicology programme.
Comments from the CEO
BioStock reached out to CombiGene’s CEO Peter Ekolind to find out more about what’s happening in the COZY01 project and what milestones he sees ahead in the coming months.
Peter, to start with, how is COZY01 different from other pain relief options?
– The most important difference is that we are working on a new mechanism of action in pain. Many pain-relieving drugs are designed for other indications such as antiepileptic drugs and antidepressants and are not optimised to affect pain. COZY01 is developed and optimised for severe chronic pain, which is why we have evaluated the risk of addiction and other side effects found in today’s existing drugs for severe chronic pain at an early stage of the programme.
The pain programme consists of two projects, both of which are based on a novel biological mechanism of action with the same target protein, PICK1. Can you tell us a little bit about this?
– It is exciting and good that new mechanisms of action are being evaluated in the field of pain, as there have been few new drugs for patients with severe chronic pain and current drugs do not provide adequate treatment. Many existing drugs also cause unwanted side effects and the risk of dependence. So far, in our studies both at our home and at the National Institutes of Health (NIH), we have not been able to demonstrate a risk of addiction or other side effects.
You have chosen not to use rats in the COZY01 project and the evaluation at NIH has thus been paused. Does this have any impact on further development?
– The plan for the toxicology study is independent of the NIH programme, but since their models only include experiments on rats, we have to pause that work.
What’s next in the project and, above all, what can you say about your ambitions going forward?
– Predicting the future is always difficult in pharmaceutical projects as one thing is certain, the road ahead is never straight. We will continue to work methodically forward to complete the preclinical studies needed to then be able to initiate the preclinical toxicology programme, which is the last step before a clinical trial permit can be applied for. We will also continue the planning and discussions with physicians and experts on the design of the first clinical study. In CombiGene’s other operations, we are also still working hard to identify interesting new research collaborations that can lead to more projects for in-licensing and to find a new partner for CG01.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
