ENKORTEN metenkefalin + tridecactide

Transcription

1 metenkefalin + tridecactide A novel drug with immunomodulatory and anti-inflammatory activity

2 : two endogenous immunomodulatory neuropeptides Combination of two neuropeptides, metenkefalin and tridecactide Both neuropeptides exert cytoprotective effect when applied individually Significant additive effect is shown in combination of both with a ratio of 5:1 5 : 1 metenkefalin: Modulates leukocyte activation and release of anti-inflammatory mediators (Th1 Th2 shift) Tyr-Gly-Gly-Phe-Met tridecactide (ACTH 1-13): Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-Lys-Pro-Val

3 : 3 steps of manufacturing, 16 different quality tests for release Active substance (peptides) synthesized by in the USA in the GMP compliant and FDA certified facilities. Peptides released for further manufacturing by Certificate of Analysis based on FDA and EMEA requirements Second step is peptides sublimation in a lyophilisate form, done by in Germany, in accordance to EMEA requirements. Release of as a final product is done by Marketing Authorization Holder Farmacija d.o.o. Tuzla, Bosnia & Herzegovina.

4 Clinical Development: focus on autoimmune diseases Development Pre-clinical Phase I Phase II Phase III Multiple Sclerosis Registration Asthma Crohn s Disease Colitis Ulcerosa Lupus Erythematosus Rheumatoid Arthritis Psoriasis

5 metenkefalin + tridecactide Disease Modifying and Relapse Treating Drug for Relapsing Remitting Multiple Sclerosis

6 : effective for both maintenance therapy and treatment of MS relapses Disease modifying treatment Dosing scheme Text Treatment of relapses 6mg s.c. tiw or 12 mg s.c. tiw 12 mg s.c. qd for three days for mild/moderate For severe, 12 mg s.c. qd for up to 10 days Effective on all three MS parameters: MRI, relapses and disability Eliminates the need to receive corticosteroid therapy during relapses

7 : consistent and convincing efficacy in both Phase II & III Effective on all three MS parameters MRI Relapses Disability - Decrease in number and average diameter of T1 lesions - In 3 months, significant reduction in size (average & max diameter and volume) of T2 lesions - 85% of relapse free patients - 67% shorter duration of relapses - 62% reduction in relapse rate (statistically significant despite of low incidence of relapses, 0.4/y) - 67% of treated patients had EDSS score improvement of Statistically significant decrease in EDSS score, allready in 3 months of treatment

8 : excellent safety profile No serious adverse events reported during the studies All reported adverse events were linked to the immediate application: injection site reaction, chills, facial redness, nasal congestion, headache However, this was not reported after every application, incidence was intermittent and individually based All blood and urine parameters monitored throughout the studies stayed within the normal range No induction of hepatic or other catalytic enzymes reported

9 Conclusions is a novel drug with immunomodulatory and anti-inflammatory activity Clinical research of is focused on autoimmune diseases, currently in 7 indications is produced in FDA certified site, released according to FDA and EMEA requirements Patent protection worldwide, valid for current formulation until 2021 In multiple sclerosis, as a disease modifying drug is effective on all three parameters: MRI, relapses and disability as a relapse treatment drug significantly reduces the duration of relapses and substitutes corticosteroid therapy No serious adverse events reported through studies