Date: 2013-07-02
Type of information:
phase: 1b
Announcement: initiation
Company: CLL Pharma (France) Leurquin-Mediolanum (France)
Product: Syn1002
Action mechanism: Syn1002 is a natural nonapeptide that is currently in clinical development to address unmet medical needs in the area of pain and autoimmune diseases. Syn1002’s activity has been demonstrated in several preclinical models (pain, rheumatoid arthritis, Crohn, etc.) and the overall data indicate that Syn1002 exhibits a potent analgesic and anti-inflammatory action at low doses. The compound is significantly more potent than morphine (x 20 - 200). Syn1002 acts by reducing pro-inflammatory cytokines (e.g. TNF-alpha and IL-6). In Phase Ia trial, CLL Pharma has shown that Syn1002 is very well tolerated in 40 volunteers.
Disease: pain
Therapeutic area: CNS diseases
Country:
Trial details:
Latest
news: CLL Pharma and Leurquin-Mediolanum have announced the initiation of Phase 1b Clinical Trial of Syn1002 in pain. Enrollment has begun in this clinical trial of Syn1002 to demonstrate its proof of concept in validated human pain models. This study follows the completion of the Phase 1 single dose-escalation study of Syn1002 which showed that the compound is very well tolerated in healthy volunteers. This randomized, double-blind, placebo-controlled Phase 1b study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of Syn1002 administered at three dose levels in comparison with pregabalin (Lyrica® - Pfizer). Leurquin-Mediolanum is sponsoring and conducting this study under its agreement with CLL Pharma.Claude Laruelle, founder and CEO of CLL Pharma, said, “We have strong momentum as we initiate this important trial to establish the proof of concept of Syn1002 in pain. With our partner Leurquin-Mediolanum, we expect to report topline results from this study before end 2013. We are also actively pursuing a second indication in autoimmune diseases as well.”
