Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal) and announces Leadership Changes to support Commercialisation - Seite 2

Dr. David Horn Solomon, Chairman at Advicenne, concluded: “A new phase has started for Advicenne with the approval of our lead candidate, ADV7103, by the European Commission. My thanks go to Peter for his hard work over the past few months and for helping us achieve this outstanding result. I am also delighted to welcome Didier to Advicenne: his experience will no doubt enable us to progress our trials for ADV7103 for cystinuria in Europe and dRTA and cystinuria the US, to the benefit of an increasing number of patients affected by rare renal conditions.”

The company has requested that Euronext suspend the listing of its shares during the trading session of 3 May 2021. The Advicenne share will resume trading at the opening of the stock market on 4 May 2021, following the publication of this press release.

About dRTA

Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure.

Whether genetic or acquired as a consequence of an immune disease, dRTA affects an estimated 30,000 patients in Europe and approximately 20,000 in the United States.

About the Phase III European program in dRTA (B21CS pivotal study & B22CS extension study)

B21CS was a multicenter pivotal study that enrolled 37 patients suffering from dRTA, including adults, adolescents, children and infants and aimed to assess the efficacy of ADV7103 compared to Standard of Care (SoC) on blood and urine biomarkers of metabolic acidosis. Patients took the SoC treatment for five consecutive days followed by five days of two daily doses of ADV7103, an innovative prolonged-release granule combination of potassium citrate and potassium bicarbonate. Based on the blood and urine parameters, the study results demonstrated the effectiveness and suggested clinical benefit of ADV7103 in dRTA patients in comparison with the SoC. The B22CS extension study was an open-label clinical study that confirmed the efficacy and safety of ADV7103 after 24 months of treatment. ADV7103 has successfully met the primary and secondary endpoints of the study and demonstrated its ability to treat biological disorders caused by dRTA.