Hot Corner: Second Life for Medication

Bioxcel uses software to find clues to alternative uses of known drugs. It has two promising product candidates.

RUPEN BOYADJIAN

Digitization is also on everyone's lips in the pharmaceutical industry. Nevertheless, she lags behind other sectors. The application areas are wide and range from the thinning of genetic data of cancer patients to apps for representatives of pharmaceutical companies. Also in the field of research numerous start-ups have emerged. However, hardly one is listed and thus accessible to a broad investor base. Moreover, it is difficult even for experts to assess which companies will prevail in the end.

One biotech start-up that combines artificial intelligence with "old pharma" is Bioxcel Therapeutics. With a program owned by its sister company, InveniAI, it scours through publicly accessible databases and research reports on existing drugs and drugs that have been discontinued. Bioxcel is trying to find evidence that these substances might work in other indications. The software is also offered to third parties. "We recently signed a contract with KHK," said founder and CEO Vimal Mehta in an interview with "Finanz und Wirtschaft". The Japanese company wants to tap a dozen of its active ingredients on possible other fields of application.

Bioxcel Therapeutics, headquartered in New Haven, Connecticut, USA, is developing two product candidates that were found using the software. One big advantage is that there is already a great deal of data available. Development is less risky, does not start from zero and does not have to go through all phases. Normally it lasts around ten to twelve years. "We want to launch innovative medicines in four to five years," Mehta said.

Anesthesia becomes sedative

The most advanced project, BXCL501, is the active substance dexmedetomidine. He was already admitted in 1999 as an anesthetic. Bioxcel is now developing dexmedetomidine for the treatment of acute arousal states. They occur in various neuro-psychiatric disorders. As part of a first development program, it has been tested on patients suffering from schizophrenia.

For this, the US health authority granted its fast-track procedure, which has an accelerated approval for the goal. Mehta is currently negotiating with the FDA for the start of a Phase III trial in the fourth quarter. With a positive course of the drug could come in 2021 on the market. Mehta estimates that it will be more in the second half of the year.

Another innovation is the dosage form as a thin film that melts on the tongue. This is an advantage compared to a syringe, as patients often suffer from anxiety or become aggressive. But people are not simply sedated. Under BXCL501 they remain responsive, the doctor can ask them for the reason for their excitement and respond to it. Analysts estimate the sales potential for schizophrenia alone at $ 500 million annually and more.

Support from the US Department of Defense

Bioxcel intends to launch a study on the use of the drug among Alzheimer's and other dementia patients this year. She has other plans for hyperactive delirium and withdrawal symptoms. One drug that could help with alcohol withdrawal is also of interest to the US military. Many soldiers suffer from post-traumatic stress disorder after use in war zones and reach for the bottle. Therefore, the Ministry of Defense (DoD) Bioxcel funded a preparatory study. "If the FDA then agrees to the study design, the DoD will also fund our advanced clinical trials," Mehta explains. For Opioidentzug he wants to start a separate study on company costs.

Bioxcel has another product candidate in oncology and neuro-oncology. BXCL701 is being tested in two phase I / II studies in the treatment of neuroendocrine tumors and pancreatic cancer. By the end of the year first results should be published at the first indication. In pancreatic cancer, the results in mice were very promising. Combined with two other drugs, the cancer could be made to disappear. If this succeeds in humans, it would be the first effective treatment against this type of cancer.

Bioxcel Therapeutics shares were issued in March 2018 for $ 11 apiece and listed on the Nasdaq. As part of the stock market correction, they had fallen to around $

2.50 at the end of last year and are now close to $ 10. As is usual with a biotech start-up, the loss has increased steadily due to growing research spending. The company is funded until mid-2020 and will need to raise new funds in the coming months. By the middle of next year, there are also some news that will provide a volatile course.