Ablynx initiates the second of two phase IIb RA studies with its anti-IL-6R nanobody, partnered with Abbvie
Ablynx 가 Abbvie와 파트너쉽을 통해 anti-IL-6R nanobody의 Phase IIb에 진입한다는 기사다. 적응증은 RA와 SLE다.
RA는 자가면역질환의 일종으로써, 관절에 통증과 부기 그리고 뻣뻣함을 유발하는 질병이다.
이 질병은 흔히 여러 관절에 발생하며 몸의 어느 관절이라도 생깁니다. 이 질병이 있는 사람들은 아프고 피로하게 느낄 수 있으며 때때로 열이 납니다. 어떤 사람들은 이 질병을 몇 달 또는 1 – 2년 정도 앓습니다. 그러다가 아무런 손상 없이 병이 사라집니다. 어떤 사람들은 그 증상이 악화되는(발적) 때가 있거나 그 증상이 더 나아지는(완화) 때가 있습니다. 어떤 사람들은 수 년이나 평생 지속될 수 있는 심한 형태의 병에 걸립니다. 이러한 형태의 질병은 심각한 관절 손상을 초래할 수 있습니다.
전신 홍반성 루푸스(Systemic Lupus Erythematosus ,SLE)는 일련의 다양한 임상적 징후와 연관되어 세포핵의 성분에 대한 항체를 생성하는 특징이 있는 전형적인 자가면역 질환이다.
- anti-IL-6R Nanobody, ALX-0061 - administered the first dose in the Phase IIb study
- administered subcutaneously (sc) as a monotherapy in adult patients with active RA who are intolerant to methotrexate (MTX), or for whom MTX is inappropriate.
- every 2 weeks or every 4 weeks for 12 weeks. Subjects will be followed for efficacy up to week 12 and for safety until 12 weeks after last dosing.
* ALX-0061 릉 IL-6R을 타겟으로하여 IL-6에 의해 유도되는 T cell activation이나 inflammation시 초기 단백질의 생성을 저해하게됨.
Ablynx initiates the second of two phase IIb RA studies with its anti-IL-6R nanobody, partnered with Abbvie
GHENT, Belgium I April 7, 2015 I Ablynx [Euronext Brussels: ABLX; OTC market: ABYLY] today announced that it has administered the first dose in the Phase IIb study to evaluate the efficacy and safety of its anti-IL-6R Nanobody®, ALX-0061, administered subcutaneously (sc) as a monotherapy in adult patients with active RA who are intolerant to methotrexate (MTX), or for whom MTX is inappropriate. The study also aims to obtain parallel descriptive information concerning the efficacy and safety of administration of sc tocilizumab (Actemra®, RoActemra®) in the same RA population.
In September 2013, Ablynx and AbbVie entered into a global license agreement, worth up to US$840 million plus double-digit royalties, to develop and commercialise ALX-0061. As part of the agreement, Ablynx is responsible for Phase II clinical development of ALX-0061 in both RA and systemic lupus erythematosus (SLE). The first Phase IIb study with ALX-0061 in combination with MTX in patients with active RA started on 17 March 2015.
This current Phase IIb study is a multi-centre, randomised study consisting of two parallel treatment groups: a double-blind part to assess the efficacy and safety of ALX-0061 sc and an open-label part (with a blinded independent joint-assessor) with tocilizumab sc, which is not used as an active comparator but to provide parallel efficacy and safety data for sc tocilizumab in the same RA patient population.
The study is expected to enrol 228 subjects in the United States, Europe and South America, who will be randomly assigned to three different dose groups of ALX-0061 sc or one dose group of tocilizumab sc[1]. Administration of ALX-0061 will be performed every 2 weeks or every 4 weeks for 12 weeks. Subjects will be followed for efficacy up to week 12 and for safety until 12 weeks after last dosing. Following completion of the 12-week dosing, eligible subjects will be invited to participate in an open-label extension study.
The primary endpoint is the ACR20 response[2] of ALX-0061 at week 12, a broadly accepted clinical response measure to demonstrate reduction in RA signs and symptoms. The secondary endpoints include higher level of response assessments of ALX-0061, documentation of efficacy of ALX-0061 over time, as well as the effects of ALX-0061 on the improvement in physical function and health-related quality of life. Other planned assessments include the determination of ALX-0061 levels, biomarkers, safety, tolerability and immunogenicity.
Dr Edwin Moses, CEO of Ablynx, commented:
"Ablynx and our partner AbbVie are committed to developing ALX-0061 for people living with rheumatoid arthritis. The start of this second Phase IIb study in this chronic and progressive disease is therefore another important milestone. We expect top line results from the two Phase IIb studies in RA before the end of 2016. If the results meet pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialisation."
About ALX-0061
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R) and has been developed for the treatment of RA and possibly systemic lupus erythematosus (SLE). IL-6 is a pro-inflammatory cytokine that plays a role in T-cell activation, production of acute phase proteins in response to inflammation, induction of immunoglobulin production, and stimulation of osteoclast differentiation and activation. ALX-0061 (26kD) has a very strong affinity for the soluble IL-6R and contains an anti-IL-6R Nanobody linked to an anti-human serum albumin (HSA) Nanobody, thereby increasing the in vivo serum half-life. Phase I/II proof-of-concept results with ALX-0061 were published in February 2013, followed by the signing of a global exclusive licensing deal with AbbVie in September 2013 for the development and commercialisation of ALX-0061.
About Ablynx
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 30 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Merck & Co., Inc, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
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