BioStock published an article about Cyxone on 29 May 2019, which can be read below.

As mainstream MS treatments get scolded by the FDA and the EMA after reports from patients experiencing severe side effects, the market for safer, more effective MS drugs is growing. On Monday, Swedish Cyxone submitted the application to start a clinical phase I trial with their MS drug candidate, T20K. Today, a day before World MS Day, BioStock takes an in-depth look at the current situation of the field and how Swedish Cyxone are aiming to plant a flag in the MS treatment market with T20K.

Multiple Sclerosis (MS) is the most common autoimmune disease affecting the central nervous system (CNS). An unknown trigger directs the immune system to attack the myelin proteins on nerve cells of the brain and the spinal cord. Over time, the autoimmune reaction damages nerve cells and their functions, and eventually break down over time.

Sweden has one of the highest rates of MS
The disease typically hits at a young age (between 20 and 40 years old), and women are two to three times more susceptible than men; a fact that still puzzles experts.

While the causes of the disease are still unknown, scientists agree that genetics plays a large role. However, genetics alone will not answer all questions. Environmental factors also, such as a temperate climate or a reduced vitamin D production from too little sun, both seem to correlate very well with disease prevalence.

The four types of MS
MS is subclassified in four different types: Clinically Isolated Syndrome (CIS), Relapsing-Remitting MS (RRMS), Secondary Progressive MS (SPMS), and Primary Progressive MS (PPMS). 85 per cent of all MS cases are classified as RRMS, where patients experience a coming (active disease or MS episodes) and going (not active disease) of symptoms without a progressive worsening of the disease.

However, a majority of RRMS patients do eventually enter the SPMS phase of the disease, where symptoms worsen over time. Meanwhile, some MS cases fall under the PPMS classification, where the disease starts out as progressive, without moments of relapse and remission. This type is generally more difficult to diagnose and treat, thereby leading to higher levels of disability.

Current medications lead to heavy side effects
There are several MS treatments on the market, but the majority consist of injectable treatments that patients struggle to incorporate into their daily routines. Infused medications and oral tablets are also available, but these can lead to severe side effects, or even death in some cases.

Most recently, news broke that Sanofi’s Lemtrada (alemtuzumab) was placed under review by the EMA after reports of MS patients experiencing cardiovascular abnormalities, including stroke and myocardial infarction, or immune deficiency leading to hepatitis.

This comes only a few months after the FDA placed a warning on Novartis’s Gilenya (fingolimod) after some patients reported worsening symptoms after stopping the medication.

The market for safer drugs expands
These regulatory advisories expose the need for safer non-injectable treatments that patients can feel good while taking without suffering any major unwanted consequences. Some big pharma players like Novartis has already taken advantage of this opening in the market by releasing potential block buster drugs such as Mayzent (siponimod) which was approved by the FDA in March. The drug is an oral medication aimed at the majority of MS patients (RRMS and SPMS), and one analysis forecasts that Mayzent will lead to 1.3 BUSD in sales by 2024.

The rise of such drugs will help drive the MS therapy market upward by 3 percent in sales by 2026.

Cyxone makes a push for the MS therapy market
Malmö-based Cyxone have their sights set on the MS market and are currently developing T20K, a plant-based pro-inflammatory cytokine inhibitor. The promise of T20K is that it has the potential to delay disease progression and mitigate or even prevent MS episodes, while simultaneously demonstrating a strong safety profile. This could reduce the disabling side-effects that the majority of MS patients currently have to endure.

T20K recently completed the preclinical program with results showing both a great safety profile and strong potential for the candidate to become a prophylactic treatment for MS. This Monday, May 27, the company submitted an application to start a phase I, first-in-human, trial to evaluate the safety and tolerability of T20K in humans. The study will be carried out in collaboration with the global clinical research organization (CRO) QPS in the Netherlands.

Read more about T20K’s potential benefits here.

A novel form of MS treatment
BioStock reached out to Cyxone’s CEO who gives us a more detailed overview of the company’s strategy to fit into the MS therapeutics market.

Kjell G. Stenberg, CEO of Cyxone, May 30 is World MS Day, a day dedicated to raising awareness about MS in general. What would you say is the most urgent unknown about MS today?

Kjell G. Stenberg, CEO Cyxone

– The need for less toxic treatments and a focus on early disease intervention. The treatment options that are currently available are primarily focused on treating patients during active MS episodes. The treatment, often with disabling side-effects, is administered to patients when they are suffering the most from the disease, during an episode, making the individual feel even more ill. Because of this, patients are prevented from participating in everyday life activities during the active periods of the disease and live in limbo as they can never know when an episode, which can last several weeks, will occur. To improve MS patients’ quality of life, safer treatments with milder side effects as well as a treatment that can stop or prevent the disease progression are therefore needed.

Could you tell us more about how T20K fits the profile of a safe prophylactic drug for MS patients?
– T20K works through down-regulating the release of the IL-2 peptide, which prevents the immune system from attacking the myelin proteins and thus protects the patient before damage occurs. In addition, T20K has a very favorable safety profile with low risk of toxicity and is absorbed and distributed in the body in a way that enables the drug to be administrated at low doses on a bi-weekly or even monthly basis. Therethrough, T20K could be administrated on a preventative basis, starting at diagnosis, with the potential of providing a constant MS inhibitory effect, meaning that the drug could mitigate or even prevent future MS episodes. We are still in a development stage, however, and our next steps are to confirm the promising preclinical results in humans.

How is T20K similar and different from newly approved Mayzent?
– The most important similarity between the two is that they’re both oral treatments, which is what would make the disease more manageable for many patients and keep the hospital visits to a minimum. T20K is a prophylactic agent positioned to start treatment of patients at diagnosis and continue treatment with regular low doses over time with the aim of preventing or stopping periods of active MS periods. Mayzent is, however, targeted at treating patients with progressed MS and is only administered in active disease periods. If T20K is as effective as our preclinical studies indicate, the time before the patient reaches these disease stages will be prolonged and some patients may never develop MS.

You had this year’s annual general meeting on May 24. What was the take home message from the meeting?
– The AGM provided a great opportunity to meet and talk to some of our shareholders. Their commitment to Cyxone and our candidates is a continuous source of encouragement and I look forward to having a more frequent interaction with them in the future, as we enter into clinical studies with our candidates.

On Monday this week you submitted the application to start a clinical phase 1 trial with T20K, what can you tell us about the study?
– The study will, given the relevant authorities’ approval, take place in the Netherlands in collaboration with the world leading global CRO QPS. We are extremely pleased to have such a competent collaboration partner by our side when we embark on our first clinical study with T20K. Because of T20K’s very favorable safety profile, we believe that the study, which is designed to evaluate the safety and tolerability of T20K in humans, has very good prospects of success.

– Provided approval from the authorities, the first-in-human study will be initiated this quarter with male healthy volunteers. This will be the very first time that T20K is studied in humans and a historical moment in our company history.

Read more about MS and World MS Day here.

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.

BioStock’s article