Subject: TRI
Cyxone revises the development plan for Rabeximod
STOCKHOLM, Sept. 24, 2020 /PRNewswire/ -- Cyxone AB (publ), a Swedish biotech company dedicated to developing improved treatments for autoimmune diseases, announces today that it has initiated a process to optimize the development plan for Rabeximod. This initiative is based on valuable input from the company's new senior medical advisors, updated market intelligence and the opportunity to prolong market exclusivity through newly filed patent applications. In parallel, the company is preparing a phase 2 clinical study of Rabeximod in Covid-19 patients, with a potential initiation already in the fourth quarter of 2020.
With a new CEO and scientific advisory board, actions have been taken that Cyxone believes will enhance long-term shareholder value, among others by improving the company's patent positions. New patent applications have been filed to extend exclusivity on Rabeximod, potentially to 2043. A patent application related to Covid-19 has also been filed.
Cyxone is currently preparing regulatory applications to enable initiation of a phase 2 trial of Rabeximod in Covid-19 patients. Provided timely regulatory approvals, the trial is expected to start in the fourth quarter of 2020. The trial, which is expected to include 300 patients, will be conducted in a number of European countries with expected readout in the third quarter of 2021. Patients affected with Covid-19 face a risk of severe respiratory failure, caused by an overreaction of the immune system. Rabeximod may be leveraged in this disease due to its ability to dampen the cytokine storm causing the acute condition and potential lethality.
After reviewing results from previous clinical studies of Rabeximod, the new market landscape and insights from consultations with scientific advisors and key opinion leaders, the target product profile has been revisited. The goal is to more precisely define the patient population and timing of treatment to elicit greatest benefit of the drug candidate. A mapping of complementary medical indications for the compound, such as Covid-19-related respiratory failures has also been conducted. Cyxone has concluded that there are compelling reasons for revising its current development plan for Rabeximod in RA to bring greatest value to patients and shareholders. The anticipated initiation of a phase 2 trial is later in 2021.
"It was essential to redefine the key selling points of Rabeximod in light of the latest treatment options in RA and other market trends. We are intrigued by the new opportunities for Rabeximod that have recently been revealed and will now work hard to compile an optimized development plan in rheumatoid arthritis. In parallel, we are looking forward to initiating the phase 2 study in Covid-19 patients - an area where the need for efficacious medical treatments is immediate, acute, immense," comments CEO Tara Heitner.
Contact
Tara Heitner, CEO
Tel: +46 70 781 88 08
Email: [email protected]
Adelgatan 21
211 22 Malmö, Sweden
This contains such information that Cyxone AB is required to make public under the EU's Market Abuse Regulation. The information was provided under the auspices of the above contact person for publication on 24 September 2020 at 23.30 CET.
About Cyxone
Cyxone AB is a clinical stage biotech company with a portfolio of immunomodulating drugs for the treatment of autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis (RA). The company's drug portfolio is based on two technological pillars in the form of oral molecules and cyclotide-based drugs that inhibit key processes in the body's cells that are typically associated with various immune-related disorders. Cyxone's technologies have the potential to address an unmet need and provide new effective and safe medicines that can improve the quality of life for patients affected by autoimmune diseases. The company has two drug candidates, T20K for MS in clinical phase I program and Rabeximod for RA in clinical phase II program. Cyxone's Certified Adviser on the Nasdaq First North Growth Market is Mangold Fondkommission AB, +46 (0)8-503 015 50, [email protected]. www.cyxone.com
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