GW Pharma: Capitalizing On Cannabis Science
Alan Brochstein, CFA • 92 Comments
Alan Brochstein, CFA • 92 Comments
Thu, May 5, 10:04 AM
Wed, Mar. 16, 12:50 PM
Mon, Mar. 14, 12:45 PM
Mon, Mar. 14, 9:17 AM
Mon, Mar. 14, 8:34 AM
- Thinly traded nano cap Zynerba Pharmaceuticals (NASDAQ:ZYNE) is up 66% premarket on average volume in connection with the bullish action related to GW Pharmaceuticals' (NASDAQ:GWPH) successful Epidiolex (cannabidiol) study results. Zynerba's lead product candidate is Orphan Drug-tagged ZYN002, a synthetic cannabidiol formulated as a gel for transdermal delivery for the treatment of Fragile X syndrome, an inherited disorder characterized by learning disabilities and cognitive impairment.
- Previously: Zynerba's cannabidiol gel an Orphan Drug for Fragile X syndrome (Feb. 25)
- Previously: GW Pharma's Epidiolex successful in late-stage study in rare form of epilepsy; shares up 127% premarket (March 14)
Mon, Mar. 14, 8:17 AM
- Small cap GW Pharmaceuticals (NASDAQ:GWPH) is up a whopping 127% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial assessing Orphan Drug- and Fast Track-tagged Epidiolex (cannabidiol) for the treatment of Dravet syndrome, a rare and catastrophic form of childhood epilepsy for which there are no approved treatments. The study met its primary endpoint of a statistically valid reduction in convulsive seizures over the 14-week treatment period compared to placebo.
- The 120-subject study compared 20 mg/kg/day of Epidiolex (n=61) to placebo (n=59). On average, patients were receiving 3 anti-epileptic drugs (AEDs), having tried and failed an average of four other AEDs. Median baseline convulsive seizure frequency was 13/month. Patients receiving Epidiolex experienced a 39% reduction in monthly convulsive seizures versus 13% for placebo (p=0.01). The superiority of Epidiolex was observed in the first month of treatment and was sustained throughout the 14 weeks.
- Epidiolex was generally well-tolerated in the trial. The most common adverse events (>10%) were somnolence (drowsiness), diarrhea, decreased appetite, fatigue, pyrexia (elevated body temperature), vomiting, lethargy, upper respiratory tract infection and convulsion. 84% of the AEs were mild or moderate. Ten patients Epidiolex patients experienced a serious adverse event compared to three for placebo. Eight Epidiolex patients discontinued treatment due to AEs versus one for placebo. The data will be presented at future medical meetings and will be submitted for publication.
- The company plans to hold a pre-NDA meeting with the FDA as soon as feasible to discuss its regulatory submission, expected by mid-year.
- A second pivotal study in Dravet in ongoing as well as two Phase 3s in Lennox-Gastaut syndrome, another form of severe childhood epilepsy.
- Dravet-related tickers: (NASDAQ:ZGNX)(NASDAQ:INSY)
Mon, Jan. 11, 5:38 PM
Dec. 24, 2015, 9:17 AM
- GW Pharmaceuticals (NASDAQ:GWPH) is up 5% premarket on light volume in response to the news that the results from a physician-led expanded access program in patients with treatment-resistant epilepsy who received Epidiolex (cannabidiol) were just published in The Lancet Neurology.
- Epidiolex, as an add-on treatment, reduced the frequency of seizures across multiple drug-resistant epilepsy syndromes and seizure types while being generally well-tolerated (3% therapy termination rate).
- The expanded access program was a "compassionate access" initiative carried out by individual investigators not affiliated with the company. Enrolled patients were some of the most treatment-resistant under care at each of the medical centers.
- 162 patients who had at least 12 weeks of follow up after the first dose of Epidiolex were included in the safety and tolerability analysis and 137 were included in the efficacy analysis. The group of 162 included 33 patients with Dravet syndrome (DS) and 31 with Lennox-Gastaut syndrome (LGS), two rare debilitating forms of epilepsy.
- DS patients treated with Epidiolex showed a median reduction in monthly motor seizures of 49.8% with half experiencing at least a 50% reduction. Four were seizure-free. In those who had seizures at baseline, the median reductions in tonic seizures and non-motor focal seizures were 69.2% (n=6) and 83.3% (n=10), respectively.
- LGS patients receiving Epidiolex showed a median reduction of 68.8% (n=14) in average monthly atonic seizures. During the four weeks of therapy, 21% (n=3) were free of atonic seizures while one patient was totally seizure free.
- Adverse events (AEs) occurred in 79% (n=128) of all patients treated with Epidiolex. The most common AEs were drowsiness (25%), decreased appetite (19%), diarrhea (19%), fatigue (13%) and convulsion (11%). Most were mild or moderate and transient.
- Top-line results from two ongoing Phase 3 studies in DS are expected in Q1 and mid-year, respectively. Top-line data from two LGS studies are expected in Q2.
Dec. 24, 2015, 9:13 AM
Dec. 8, 2015, 5:37 PM
Oct. 16, 2015, 5:41 PM
Sep. 15, 2015, 10:06 AM
- GW Pharmaceuticals (GWPH +11.2%) heads north on increased volume in response to its announcement of positive top-line results in a Phase 2a clinical trial assessing Cannabidiol (CBD) in 88 schizophrenia patients who failed to respond adequately to first-line anti-psychotic medications. In the study, participants remained on their anti-psychotic treatments and were randomized to receive CBD or placebo as adjunct therapy.
- Compared to placebo, patients in the CBD cohort showed a statistically significant improvement in the PANSS positive sub-scale (p=0.018), the Clinical Global Impression of Severity (p=0.04) and Clinical Global Impression of Improvement (p=0.02). CBD was also better than placebo in the area of cognition, but the results were shy of statistical significance (p=0.07). The trial was a proof-of-concept study so the endpoints were exploratory. There was no single primary efficacy endpoint.
- CEO Justin Glover says, "These findings further reinforce the potential role of cannabinoids in the field of neuropsychiatric disease. We believe that the signals of efficacy demonstrated in this trial, together with a notably reassuring safety profile, provide GW with the prospect of a new and distinct cannabinoid neuropsychiatric product pipeline opportunity. Similar to our approach with Epidiolex, we believe that our future research in this area may lie within pediatric orphan neuropsychiatric indications and we intend to explore this as a focus for future trials."
Sep. 15, 2015, 9:12 AM
Apr. 14, 2015, 12:48 PM
- After the close yesterday, the American Academy of Neurology released data on GW Pharmaceuticals' (GWPH +10.1%) investigational Epidiolex (cannabidiol) from an FDA-authorized "expanded access" program for children and young adults with treatment-resistant epilepsy who have exhausted available treatment options. The company will present the full data during a poster session on April 22.
- The data provide treatment effect information on 137 patients who had been treated at least 12 weeks with Epidiolex plus additional patients still within the first 12 weeks of treatment.
- Per the abstract, safety data were collected on 213 patients with treatment-resistant epilepsies. Efficacy calculations were based on 123 patients who had at least 12 weeks continuous exposure to Epidiolex. Etiologies included Dravet and Lennox-Gastaut (LGS) syndromes in addition to 10 other conditions.
- The total median reduction from baseline in convulsive and non-convulsive seizures was 46% at Week 12. The frequency of convulsive seizures in Dravet patients was reduced 51% at Week 12 (n=23). In LGS patients, atonic (muscles lose tone) seizure frequency was reduced 52% at Week 12 (n=10). Adverse events included sleepiness (21%), diarrhea (17%), fatigue (17%) and decreased appetite (16%). Nine patients discontinued therapy due to adverse events.
- Epidiolex is currently in Phase 3 development.
Apr. 14, 2015, 9:12 AM
Apr. 13, 2015, 5:39 PM
GW Pharmaceuticals Plc engages in the business of discovering, developing and commercializing novel therapeutics from proprietary cannabinoid product platform in a broad range of disease areas. The company operates through the following segments: Commercial, Sativex Research & Development and... More
Industry: Drug Manufacturers - Other
Country: United Kingdom
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