biotx.ai launches COVID-19 clinical trial

biotx.ai’s COVID-19 treatment enters phase 2b clinical trials.

It has a clean and transparent safety record, it targets those patients that are severely ill, it works for new variants and it can be rolled out at scale. All development was done synthetically on our AI platform, in record time.

The COVID-19 dilemma

Various efforts like vaccines and antivirals, have been directed towards the early phase of COVID-19 infections, the so-called viral response phase. Yet differing mutations and a return to economic activity led to 2021 deaths exceeding 2020 deaths.

Those who slip through the vaccine net or have a predisposition to becoming more ill are essentially dying due to a severe auto-immune reaction which attacks cells in the lungs. Once established, the process of NETosis, Thromboinflamation and ultimately death, can only be prevented by immunomodulators like Tocilizumap, a biologic that is complex to make and facing worldwide supply chain issues.

biotx.ai reimagines how the disease should be treated: Focused and future-proof

Biotx.ai launches a phase 2b clinical trial for the first widely applicable treatment for severe and critically ill COVID-19 patients, which enables us to drastically reduce fatalities.

Our approach focuses on helping those patients who are at a high risk of dying from COVID-19 and prevents them from falling critically ill and dying.

Our treatment is designed such that it will work against future variants of the virus.

It was discovered in record time by our AI platform that allows revolutionary new insights from genomic data and simulates how the treatment would fare in humans in clinical trials, without any wet lab experiments.

Works regardless of virus variant

Unlike vaccines and antivirals that aim to bind to the virus and prevent it from entering the cells, our approach is host-directed. This means we prevent the harmful host reaction that makes patients critically ill. The advantage is that this approach works regardless of the virus variant - it will work for future variants of COVID-19 and also for other respiratory illnesses.

CDK6 inhibition to stop NETosis

COVID-19 takes a mild course for the overwhelming majority of patients, but in some patients the immune system attacks the patient's lungs - these are the patients that end up dying. The processes that lead to death are called NETosis and Thromboinflammation - and are the exact mechanism that we address.

We focus on a drug target called CDK6, which is central to this overreaction of the immune system. Inhibiting CDK6 reduces the number of neutrophil cells (a type of white blood cells) and thus prevents harmfull NETosis and Thromboinflammation.

A proven pathway

CDK6 inhibitors address the same general pathway also targeted by authorized immunomodulator treatments for critical cases. The advantage of CDK6 inhibitors is that their function is more specific and thus there is more leniency when it comes to timing of administration.

Clinical evidence and proven safety

Some CDK6 inhibitors have long been used for the treatment of breast cancer. Safety and adverse effects have been carefully assessed in long term studies.

Beyond that there are case reports of patients that contracted COVID-19 while on CDK6 inhibitors. These patients showed an unusually mild course of COVID-19.

Mounting case reports suggesting safety and positive effects led to the publication of a paper prescribing that patients treated with CDK6 inhibitors for a disease other than COVID-19 should remain on the treatment after contracting COVID-19.

Scalability

Unlike immunomodulators, CDK6 inhibitors are small molecules. They can be produced at scale and thus reach a much greater number of patients.

Conclusion

We enter a clinical phase 2b trial with our COVID-19 treatment that targets patients particularly vulnerable to the severe course of the disease and fills the therapeutic gap that has been causing high death numbers in COVID-19 patients.

Our treatment was discovered and brought towards phase 2b clinical trials purely computationally, without any dedicated wet lab experiments. It’s safety record is transparent and well understood and initial evidence suggests efficacy. The treatment is a small molecule and can be produced at scale without facing the supply chain issues of biologicals like Tocilizumab.

It thus provides doctors with a tool to give the best treatment for every single COVID-19 patient that slipped through the net of preventative and early treatments like vaccines and antivirals.

We are already working on extending this treatment to other respiratory illnesses resulting in the same auto-immune reaction and our AI platform has produced promising leads for novel treatments of completely different disease areas.