Biotts: Polish biotech revolutionizes drug delivery for cancer and diabetes

Breslau-based Biotts is an innovative biopharmaceutical company, specializing in proprietary carriers that increase the bioavailability of active substances, and pharmaceutical formulations. The company’s breakthrough technology enables transdermal application of drugs through the skin, allowing to reduce the negative side effects of oral and intravenous drugs, reduce their doses and increase the effectiveness of active substances. Biotts’ transdermal system can be used for the application of commonly used anti-diabetic, oncology, anti-inflammatory or analgesic drugs. Now Biotts has become the first in the world to successfully administer the peptides semaglutide and liraglutide through the skin, in transdermal form.

Biotts patent an opportunity for big pharma

When Biotts administered semaglutide through the skin in a transdermal form that is convenient for patients, Biotts obtained significantly higher bioavailability results for the drug’s active ingredients compared to the oral form. This is important insofar as the latter’s absorbability is at a very low level and comes with many limitations. For pharmaceutical companies, the transdermal form of semaglutide will therefore mean huge savings due to the reduction in the amount of the drug substance used. The Wroclaw-based company plans to conduct the first clinical trials on patients with semaglutide administration as early as 2024.

Semaglutide is the latest star of global medicine – it is a substance used to treat type 2 diabetes, obesity and insulin resistance. It stimulates insulin secretion, reduces glucagon production and helps regulate blood sugar levels. More recently, clinical trials have also been underway to use the drug to treat Alzheimer’s disease. The worldwide sales boom of semaglutide is linked to its effectiveness in reducing body weight. In the U.S., the substance was quickly declared a phenomenon among celebrities and on social media, which contributed significantly to the increased demand for its global production. According to available market information, Novo Nordisk – a leading manufacturer of insulin and popular diabetes drugs based on semaglutide, such as Ozempic and Wegovy – reported a 93% increase in sales of semaglutide in 2022. The unprecedented sales would have been even higher had it not been for limitations due to the substance’s production capacity. At the end of June, Novo Nordisk announced the completion of trials of semaglutide in increased-dose tablets of 25 mg and 50 mg – as opposed to 1 mg in Ozempic, 2.4 mg in Wegova and 14 mg in Rybelsus – leading to weight loss of up to 15%. The Danish manufacturer expects them to be approved by European and U.S. regulators later this year. As reported by Reuters, industry analysts predict that the market for semaglutide and similar drugs will reach $100 billion in annual sales within this decade.

Diabetes patients test Biotts patches

Advanced clinical trials of Biotts’ solution are also currently underway on patients with type 2 diabetes, with the first group of patients testing MTC-Y carriers with dapagliflozin, which lowers blood glucose levels by contributing to increased renal excretion of glucose in urine. MTC-Y carriers with dapagliflozin are special skin patches with fast and deep absorption in GMP quality, developed by Biotts for the first series of clinical trials of transdermal systems, enabling the transport through the skin into the bloodstream of antidiabetic substances. The transdermal form allows the drugs to rapidly penetrate the skin without irritating it. The planned completion of the Phase 1A clinical trials, including the analytical portion, is the end of the third quarter of this year.

“Phase 1A clinical trials are primarily intended to prove the efficacy and safety of Biotts’ patented MTC-Y carrier. Promising preclinical studies on larger molecules such as semaglutide, coupled with the soon-to-be-confirmed efficacy of the carrier, pave the way for us to revolutionize the treatment of chronic diseases.”
– emphasizes Dr. Paweł Biernat, CTO at Biotts

“The human clinical trial could result in a historic success that will open up new opportunities for the pharmaceutical industry, drug manufacturers and change the lives of thousands of patients. Biotts’ innovative technology will not only reduce the cost of treatment, but will provide millions of patients with the ability to take their medications in comfort, replacing, for example, oral forms of drug administration that burden the digestive system, or painful injections. Such a solution will enable a breakthrough in the market for type 2 diabetes drugs, which has a high growth rate and is estimated to be worth up to $61.2 billion by 2024.”
– adds Jan Hendriks, CEO of Biotts

Big steps to commercialization

Of the thousands of drugs currently approved by the US FDA regulator, fewer than 30 are approved for transdermal administration. Despite this, according to the study, the market for transdermal drug delivery systems will be worth $8.7 billion by 2027, with an average growth rate of 6.39% (CAGR) over the 2021-2027 timeframe. So far, effective transdermal drug delivery has only been achieved with small molecules (<500 Da). The development of the MTC-Y technology, developed by a Wroclaw-based startup, has effectively removed these limitations.

Biotts’ transdermal method allows for transdermal delivery of larger molecules as well (up to 6000 Da, although the true limits of this technology are not yet known), greater control of the active substances released into the body, and a reduction in the frequency of administration – thus improving the quality of life for patients. To speed up the commercialization process, the company has transformed its Boston office into a branch of Biotts US and has begun working with US biopharmaceutical experts.

“Semaglutide is an extremely important market to pursue, with the U.S. semaglutide market projected to be worth $65 billion by 2030 and an estimated global market value of up to $100 billion. Biotts, with its transdermal formulation of semaglutide, is well positioned to generate significant revenue early on, based on an abbreviated regulatory approval pathway. We are ready to partner with pharmaceutical companies to develop and commercialize the world’s only non-invasive transdermal formulation of semaglutide.”
– indicates Devrim Aran, President of Biotts US