Human Insulin Analogues of a Prolonged Activity - NAWA

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According to the estimates of the World Health Organisation, more than 300 million people will be suffering from diabetes in 2025. Scientists from the Łukasiewicz Research Network – Institute of Biotechnology and Antibiotics have developed ‘candidates’ for new long-acting drugs for diabetics.

DIABETES IS a disorder that manifests itself in an impaired production of insulin – a hormone that controls the glucose level in blood. Untreated diabetes leads to serious eye damage, failure of the kidneys and heart, or even death. That is why, in order to control the disease, diabetic patients using insulin require injections, sometimes several times a day.

Innovative Biopharmaceuticals

A solution that could improve the quality of life of diabetics are the insulin analogues developed at the Institute of Biotechnology and Antibiotics (IBA) as a part of the project entitled ‘Centre of Medicinal Product Biotechnology. Package of innovative biopharmaceuticals for human and animal therapy and prophylaxis.’, in which the scientists developed long-acting analogues of human insulin, among other drugs.

‘Our aim was to produce insulin analogues with prolonged action, which would provide a stable therapeutic effect. It means that the patient would not have to take the medication frequently: it would suffice to take one dose per day, or even one every few days,’ explains Dr. Marta Zapotoczna, IBA Deputy Director.

The Institute specializes in research and development of biopharmaceuticals. To produce the insulin analogues, the researchers used genetically modified Escherichia coli bacteria with a gene encoding modified insulin. The bacteria were used to produce large amounts of proteins with specific properties. Proteins obtained in this manner then become the active drug. As a result, the team obtained proteins with decreased solubility in a neutral environment. In other words, once injected into the body, the new forms of the hormone took longer to absorb into the bloodstream and remained active for a longer period.

Three Promising Variants

The researchers successfully produced several variants of the insulin analogues, with three deemed particularly promising by the team. The action of insulin AKR was ultralong, showing activity in animals even up to 28 days. On the other hand, the insulin SK3R was the most similar to the marketed insulin glargine, but additionally did not cause dangerous fluctuations in the sugar level in blood. The third substance developed at IBA is a rapid-acting human insulin analogue, biosimilar to the preparation already known on the market – insulin lispro.

‘The new technologies were characterised by simplicity and high effectiveness with a high degree of purity of finished products. Combined with the good results of the set of preclinical trials and stability tests, this has confirmed that they are perfectly suitable for commercialization,’ says Dr. Monika Bogiel.

The inventions have been patented and attracted the interest of industry. The rapid-acting insulin analogue will be produced in India, and insulin AKR is presently the subject of negotiations between IBA and a pharmaceutical company.

This is not the first time that the IBA has developed insulin. It was here that the first Polish biotechnological drug and the world’s third recombinant human insulin were invented in the 1990s. ‘We are best known for insulin and its analogues, yet this is not the only group of biopharmaceuticals we develop. We develop and produce vaccines,

growth hormone, interferons and other products as well. We are able to invent a new biopharmaceutical drug and bring it all the way to the stage of production in accordance with the GMP guidelines,’ Dr. Zapotoczna says.

Łukasiewicz Research Network

– Institute of Biotechnology and Antibiotics