Active Biotech AB. (12/1/17). "Press Release: Active Biotech Announce Results in ARPEGGIO Phase II Trial with Laquinimod in Primary Progressive MS". Lund.

	Organisation	Active Biotech AB (Nasdaq OMX Nordic: ACTI)
	Group	Active Biotech (Group)
	Organisation 2	Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
	Product	laquinimod
	Product 2	clinical research
	Person	Tuvesson, Helén (Active Biotech 201707– CEO before CSO since 201103 before Head Dept Preclinical Developm since 1998)
	Person 2	Kolam, Hans (Active Biotech 201208 CFO)

Active Biotech (Nasdaq Stockholm: ACTI) today announced initial results from the Phase II proof of concept study of laquinimod in Primary Progressive MS (PPMS) sponsored by Active Biotech's partner Teva Pharmaceuticals Industries Ltd. The primary endpoint of brain atrophy as defined by percent brain volume change (PBVC) from baseline to week 48, was not met after daily oral doses with 0.6 mg laquinimod.

The secondary endpoint of time to confirmed disability progression was also not met. There was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg.

The clinical safety profile of laquinimod 0.6 mg daily in PPMS patients resembled the safety profile demonstrated in relapsing remitting MS patients. The most common adverse events reported by patients treated with laquinimod 0.6 mg daily were nasopharyngities, headache, upper respiratory tract infection and back pain.

Data from the trial will be presented at a future scientific conference and the full results will be published.

Lund, December 01, 2017

Active Biotech AB (publ)

Helén Tuvesson
President and CEO

For further information, please contact:
Helén Tuvesson, President and CEO
Tel. +46 46 19 21 56

Hans Kolam, CFO
Tel +46 46 19 20 44

The ARPEGGIO study is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled, Phase II trial evaluating the efficacy, safety and tolerability of laquinimod at 0.6 and 1.5 mg/day in patients with PPMS. The higher-dose (1.5 mg) arm of the trial was discontinued in January 2016. The primary endpoint of the study is brain atrophy as defined by PBVC from baseline to week 48, assessed by magnetic resonance imaging (MRI) analysis. Secondary endpoints include time to confirmed disability progression, the number of new T2 lesions and extended MRI data.

About laquinimod

Laquinimod is a once-daily oral, investigational, selective aryl hydrocarbon receptor (AhR) activator targeting neurodegeneration and inflammation with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease (HD). Active Biotech has an agreement with Teva Pharmaceutical Industries Ltd since 2004 covering the development and commercialization of laquinimod.

Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties is in development for neurodegenerative diseases in partnership with Teva Pharmaceutical Industries Ltd. ANYARA, an immunotherapy, in development for cancer indications in partnership with NeoTX Pharmaceuticals. Furthermore, commercial activities are conducted for the tasquinimod, paquinimod and SILC projects. Please visit www.activebiotech.com for more information.

Active Biotech AB
(Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46 19 20 00

This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 13.00 p.m. CET on December 1, 2017.

Record changed: 2023-06-05