STOCKHOLM, Jan. 29, 2020 /PRNewswire/ -- Cyxone (publ), a Swedish biotech in autoimmune diseases, announced today that an order of more Rabeximod substance will be placed earlier than expected with the primary objective of providing optimal conditions for conducting the clinical phase IIb trial. This proactive and strategic decision follows the initiation of preparatory work for substance capsulation that started early this year and is part of the Phase IIb program. As a result, the first patient is expected to enter the clinical phase IIb trial in the first quarter of 2021.
In conjunction with the capsulation work that started earlier this year, thorough evaluations of the existing Rabeximod substance were conducted. Findings indicate it would be preferable to use newly manufactured substance (active pharmaceutical ingredient; API) for the clinical study. At this time, the capsulation vendor will continue the preparatory work and commence capsulation work once the new substance is manufactured. The Phase IIb trial is designed to administer Rabeximod to patients in capsules, why this step is a critical part of the Phase IIb program.
"We are confident that this is the right approach for the Rabeximod program. An important task ahead will be to limit the overall delay of the program, which we aim to achieve by working closely together with our partners. We want the best conditions for the Phase IIb study to succeed and for this, we see that newly manufactured substance enables just that," says Malin Berthold, Chief Operating Officer at Cyxone.
Ola Skanung, interim CEO & CFO at Cyxone, comments "It is a highly strategic decision focusing on risk mitigation. We see that this is the right time to take this action when the impact on the Rabeximod program will be limited in delays, costs and resources. Since manufacturing more substance was always in the plan, we see that bringing the delivery forward may also help prepare us for potential development collaboration or other partnering activities requiring substance."
The planned multi-center Phase IIb clinical trial is in parallel in the process of securing permission to conduct the clinical study in select countries. To date, approvals from Ethics Committees have been obtained in two countries with the additional applications still in process. After the Ethics Committee approval, additional documentation will be submitted to the final regulatory approval with each country's competent authority. Once permission is approved, the patient recruitment can commence in the selected countries. The first patient is expected to be dosed in the first quarter of 2021.
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 January 29, 2020 at 09.50 CET.
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
Ola Skanung, interim CEO & CFO
Phone: +46 (0) 705 121 040
Email: [email protected]
Cyxone AB (publ)
Adelgatan 21 211 22
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