“We would like to reassure the patients who rely on our products and the shareholders who have invested in our growth that our business remains strong,” Ken d’Entremont, CEO of Medexus, said in a press release. “Our supply channel is secure and we are working to ensure it remains so to support the demand for our products in the market.”
“In particular, we would like to reassure patients who rely on Ixinity, the intravenous recombinant factor IX therapeutic for hemophilia B acquired by Medexus at the end of February, that the product is readily available and we will continue to work towards ensuring their continued access to this life saving medication,” he added.
Ixinity, formerly known as IB1001, is a recombinant (man-made) version of the human clotting factor IX (FIX) — the blood clotting protein that is missing in people with hemophilia B. It is a form of replacement therapy that works by providing patients with the blood clotting factor they lack.
The therapy has been approved by the U.S. Food and Drug Administration (FDA) to treat patients, 12 and older, with hemophilia B. It is recommended not only to control and prevent spontaneous bleeding episodes, but also to manage blood loss during surgery.
Despite confidence in the supply of its treatments during the pandemic, Medexus is anticipating that the COVID-19 outbreak will result in significant delays in patient enrollment for its current pediatric trial of Ixinity.
Following promising results seen in prior clinical studies, the Phase 4 trial (NCT03855280) is seeking to extend Ixinity’s current indication to include children with hemophilia B younger than 12. Specifically, the open-label study is designed to assess the safety, efficacy, and pharmacokinetic properties of prophylactic (preventive) treatment with Ixinity in 22 previously treated children with moderate to severe hemophilia B. Pharmacokinetics is the study of how a compound is absorbed, distributed, metabolized, and eliminated from the body.
The trial includes three phases. The initial phase will assess the safety, tolerability, and pharmacokinetic properties of Ixinity, given in a single dose. The treatment phase will involve twice weekly prophylactic treatment with Ixinity, dosed at 35–75 international units (IU)/kg, for approximately six months. It will be followed by a continuation phase in which participants may continue treatment for six additional months.
Children participating in the trial will be divided into two groups: patients younger than 6 and those from 6 to 12.
The dosing of the first participant was recently announced by Aptevo, Ixinity’s original developer. The trial is currently recruiting patients in Moldova, Ukraine, and South Africa. More information is available here.
The delay in enrollment in the pediatric trial is not expected to significantly impact Medexus’ revenue forecasts, as this pediatric indication is incremental, not core, to the company’s projections. In the face of the ongoing outbreak, Medexus has restricted travel, and marketing and promotional initiatives.
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