Wed, Feb. 24, 1:40 PM
- ViiV Healthcare, the HIV-focused joint venture between GlaxoSmithKline (GSK -1.1%), Pfizer (PFE -0.5%) and Shionogi Limited (OTC:SGIOF)(OTCPK:SGIOY), announces the results from a 41-week Phase 2a study, ECLAIR, assessing the safety, tolerability, dosing and satisfaction with long-acting, injectable cabotegravir as monotherapy for the prevention of HIV infection in adult males not at high risk of acquiring HIV. The data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
- ECLAIR randomized 127 HIV-negative subjects 5:1 to cabotegravir or placebo beginning with a safety assessment on oral cabotegravir 30 mg or placebo tablet for four weeks followed by an intramuscular injection of 800 mg cabotegravir or placebo (sterile saline) every 12 weeks for three cycles.
- The proportions of participants who completed three injections for cabotegravir and placebo were 93% (n=87/94) and 95% (n=20/21), respectively. The incidences of Grade 2 (moderate) to Grade 4 (life-threatening or disabling) adverse events during the injection phase were 80% (n=75/94) and 48% (n=10/21), respectively. The most common Grade 2-4 AE was injection site pain (59% and 5%, respectively). The incidences of all grades of adverse events during the injection phase were 98% (n=92/94) and 90% (n=19/21), respectively.
- Following repeat injections, 74% (n=67/91) favored long-acting cabotegravir over the oral version.
- ViiV intends to advance cabotegravir to Phase 3 development later this year.
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Dec. 3, 2015, 7:29 PM
- Specialty pharmaceutical firm Egalet (EGLT -2.6%) says it's terminating a collaboration with Shionogi Limited (OTCPK:SGIOY) around an abuse-deterrent, extended-release hydrocodone candidate.
- The move ends a two-year relationship and means Egalet gains worldwide rights to the Phase 1 product candidate.
- The deal had means upfront and milestone payments totaling $20M and an investment of $15M in its stock connected to its 2014 IPO. Egalet says it terminated the deal "with the change in [Shinogi's] internal priorities."
Nov. 3, 2015, 9:32 AM
- A Phase 2b clinical trial, LATTE 2, assessing long-acting injectable formulations of Viiv Healthcare's (NYSE:GSK) (NYSE:PFE) (OTC:SGIOF) (OTCPK:SGIOY) cabotegravir and Janssen's (NYSE:JNJ) EDURANT (rilpivirine) for the maintenance treatment of HIV-1 infection met its primary endpoint at 32 weeks. The results showed the two-injectable-drug regimen was comparable in maintaining viral suppression rates to a three-drug oral regimen of cabotegravir and two nucleoside transcriptase inhibitors.
- Viral suppression rate (plasma HIV-1 RNA <50 c/ml) at week 32 for the two-drug regimen dosed every eight weeks was 95% and 94% for those dosed every four weeks. This compared favorably to 91% for the three-drug regimen.
- Patients on the four-week regimen reported more adverse events (AEs) leading to withdrawal (5%; n=6) than those on the eight-week regiment (2%; n=2) and those on the oral regimen (2%; n=1). The most common AE was injection site pain (93% of injection recipients). Two patients in the eight-week cohort withdrew for injection intolerance. Two patients, one in the eight-week group and one in the oral group, experienced virologic failure.
- Cabotegravir is an investigational integrase strand transfer inhibitor and analogue of ViiV's Tivicay (dolutegravir). It is being evaluated as a once-daily oral tablet and as a long-acting intramuscular injection.
- The results will be presented at an upcoming scientific conference.
Aug. 3, 2015, 8:27 AM
- Shionogi (OTC:SGIOF) announces that once-daily naldemedine achieved its primary and secondary endpoints in a third Phase 3 trial (COMPOSE II) for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain. Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist.
- The study showed that a 0.2 mg tablet of naldemedine administered once daily significantly improved the frequency of spontaneous bowel movement compared with placebo over 12 weeks. Naldemedine was well-tolerated with the most frequently reported side effects being gastrointestinal disorders.
- This is the third Phase 3 trial in which naldemedine achieved its primary and key secondary endpoints.
Nov. 22, 2013, 12:00 PM
Mar. 25, 2013, 6:20 AMAstraZeneca (AZN) and partner Shionogi (SGIOF.PK) have received a boost after Actavis (ACT) unit Watson Laboratories and Egis agreed to drop their attempts to introduce generic versions of AstraZeneca's blockbuster cholesterol drug Crestor until May 2016. The settlement comes after a court upheld the patent on the treatment in December. | Mar. 25, 2013, 6:20 AM
Jul. 11, 2012, 4:42 AM
Sep. 1, 2008, 11:22 AM
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