- Primary endpoint achieved in both Epidiolex doses with high statistical significance compared to placebo - 

- Today’s data represents the third positive Phase 3 pivotal trial for Epidiolex reported in 2016 -

- Data reinforce the potential of Epidiolex to be an important new medicine for patients who suffer from this treatment-resistant childhood-onset epilepsy -  

- Company to hold investor conference call today at 8:00 a.m. EDT/13:00 BST -

 

LONDON, Sept. 26, 2016 -- GW Pharmaceuticals plc (GWPH) (GWP.L) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex® (cannabidiol or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.

Once-daily dose identified for the pivotal Phase 3 study

Well tolerated with no drug-related severe or serious adverse events reported

 

SALT LAKE CITY, Sept. 26, 2016  -- Lipocine Inc. (LPCN), a specialty pharmaceutical company, today reported positive top-line results from a Phase 2b clinical study of LPCN 1111, a novel oral testosterone replacement therapy ("TRT") product candidate. The primary objectives of the study were to determine the Phase 3 dose of LPCN 1111 along with the safety and tolerability of LPCN 1111 and its metabolites following oral administration of single and multiple doses in hypogonadal males.

OXFORD, United Kingdom, Sept. 26, 2016  -- Summit Therapeutics plc (SMMT) (SUMM.L), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficileinfection, today announces it has received Fast Track designation from the US Food and Drug Administration (‘FDA’) for ezutromid in the treatment of DMD. Ezutromid is a utrophin modulator and represents a potential disease modifying treatment for all patients with the fatal muscle wasting disease DMD.

 

“Fast Track designation underscores the importance that the FDA places on developing new treatments for life-threatening disorders, such as DMD, and aligns well with our recently outlined strategy to accelerate the development of ezutromid to market,” said Glyn Edwards, Chief Executive Officer of Summit. “As a utrophin modulator, ezutromid has the potential to significantly advance the state of care for all patients with DMD, regardless of their underlying genetic fault. We look forward to ezutromid’s continued progress in our ongoing Phase 2 clinical trial, PhaseOut DMD.”

BOULDER, Colo., Sept. 26, 2016 -- Array BioPharma (ARRY) and Pierre Fabre today jointly announced top-line results from Part 1 of the Phase 3 COLUMBUS (Combined LGX818 Used with MEK162 in BRAF Mutant Unresectable Skin Cancer) study evaluating LGX818 (encorafenib), a BRAF inhibitor, and MEK162 (binimetinib), a MEK inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The study met its primary endpoint, significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone.

 

"The COLUMBUS Part 1 trial results demonstrate a robust PFS benefit associated with the combination of binimetinib plus encorafenib versus vemurafenib in patients withBRAF-mutant melanoma," said Ron Squarer, Chief Executive Officer, Array BioPharma. "We look forward to working with global regulatory authorities as they evaluate our planned submission."