– Potential CHMP opin­ion moved from Q4 2018 into H1 2019
– Guidance for ini­tial EU com­mer­cial launch in H2 2019 unchanged
– FDA meet­ing held under RMAT sta­tus
– Phase 3 study on track with over 20 open sites expect­ed by end 2018, of which sev­er­al in US

Amsterdam, The Netherlands, October 12, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announces a reg­u­la­to­ry and clin­i­cal update for ATIR101.

Europe EMA
Following recent meet­ings of the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), Kiadis Pharma received a Day 180 sec­ond List of Outstanding Issues relat­ing to its mar­ket­ing autho­riza­tion appli­ca­tion (MAA) for ATIR101. Kiadis Pharma has com­plet­ed its eval­u­a­tion of these remain­ing Day 180 ques­tions. Addressing the ques­tions will require addi­tion­al analy­ses of exist­ing clin­i­cal data. As expect­ed, no new exper­i­men­tal or new clin­i­cal data needs to be gen­er­at­ed. EMA has accept­ed the Company’s request for the time need­ed to respond to the remain­ing ques­tions. As a result, the tim­ing of the expect­ed CHMP opin­ion has moved from the fourth quar­ter of 2018 into the first half of 2019. Following poten­tial EU approval, which typ­i­cal­ly fol­lows a pos­i­tive CHMP Opinion with­in 67 days, Kiadis Pharma intends to com­mer­cial­ly launch ATIR101 in a first EU mem­ber state in the sec­ond half of 2019, which is unchanged ver­sus pre­vi­ous guid­ance.

In 2017, the US Food and Drug Administration (FDA) grant­ed ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) des­ig­na­tion. Similar to a Breakthrough Therapy des­ig­na­tion, RMAT sta­tus allows com­pa­nies devel­op­ing regen­er­a­tive med­i­cine ther­a­pies to inter­act with the FDA more fre­quent­ly, and RMAT-des­ig­nat­ed prod­ucts may be eli­gi­ble for pri­or­i­ty review and accel­er­at­ed approval. As part of its RMAT sta­tus, Kiadis Pharma is ben­e­fit­ting from pro­duc­tive inter­ac­tions with the US FDA, includ­ing a recent meet­ing.

Phase 3 clin­i­cal tri­al
The Company is on track with the ongo­ing Phase 3 clin­i­cal study to enroll 250 patients at lead­ing trans­plant cen­ters glob­al­ly. The Company has now enrolled 22 patients and has 14 sites open in 7 coun­tries. Kiadis Pharma expects to have over 20 sites open by the end of 2018, includ­ing sev­er­al US sites. An inter­im analy­sis of the Phase 3 study is expect­ed in the sec­ond half of 2020.

Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed: “We are pleased with our con­tin­ued clin­i­cal and reg­u­la­to­ry progress and remain on track for the ini­tial com­mer­cial launch of ATIR101 in a first EU coun­try in the sec­ond half of 2019. We are con­fi­dent that we can address the remain­ing ques­tions from EMA, allow­ing for a CHMP opin­ion in the first half of 2019. The FDA grant­i­ng the RMAT sta­tus is a clear val­i­da­tion of the impor­tance of ATIR101 and has result­ed in pro­duc­tive inter­ac­tions with the US FDA. We are very pleased with progress made in our Phase 3 clin­i­cal tri­al to date. We are again a step clos­er to bring­ing ATIR101 to patients.