The last week was pretty low key for the biotech sector. Key highlights included Celgene’s (CELG - Free Report) plaque psoriasis drug achieving its primary endpoint in a late-stage study. Gilead Sciences, Inc. (GILD - Free Report) presented new data on its latest HIV regimen.
Recap of the Week’s Top Stories:
Celgene Reports Positive Data on Plaque Psoriasis Drug: Celgene announced that the phase III study, STYLE, on plaque psoriasis drug, Otezla, met its primary endpoint. The phase III, multicenter, randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of Otezla in patients with moderate-to-severe plaque psoriasis of the scalp. The study enrolled 303 people who were randomized in the ratio of 2:1 to receive Otezla 30 mg twice daily or placebo for the first 16 weeks.
Results of the study showed that Otezla 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment (ScPGA) response at week 16 compared with placebo. The study also met its secondary endpoint of whole body itch numeric rating scale (NRS) — defined as at least a 4-point reduction from baseline — at week 16 with Otezla versus placebo.
Otezla is currently being evaluated in phase III studies for Behçet's disease, atopic dermatitis, and expanded indications in psoriatic arthritis and plaque psoriasis. Global submissions are planned in 2018. The label expansion of the drug should boost sales.
Gilead Presents Data on HIV Regimen Biktarvy: Gilead announced positive 96-week results from a phase III study on Biktarvy. The phase III randomized, double-blinded study (Study 1489) evaluated the safety and efficacy of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults. The results from the ongoing study showed that Biktarvy was statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC/DTG/3TC) through 96 weeks of therapy.
At week 96, non-inferiority was maintained from the primary endpoint measurement at week 48, with 87.9% (n=276/314) of patients taking Biktarvy and 89.8% (n=283/315) of patients taking ABC/DTG/3TC achieving HIV-1 RNA levels less than 50 copies/mL (difference: -1.9 percent, 95 percent CI: -6.9 percent to 3.1 percent, p=0.45).
Biktarvy was well tolerated through 96 weeks. The study is ongoing and will remain randomized and blinded through 144 weeks.
Biogen Presents Data on Spinraza: Biogen (BIIB - Free Report) presented encouraging interim results from an ongoing open-label, single-arm efficacy and safety study, NURTURE, on Spinraza in 25 presymptomatic infants with Spinal Muscular Atrophy (SMA). The interim analysis evaluated survival and respiratory intervention rates in infants who were genetically diagnosed with SMA and began treatment in the presymptomatic stage of the disease. The results from the analysis showed that all patients in the study were alive and none required tracheostomy or permanent ventilation (as of May 2018). Moreover, 22 of the 25 participants were able to walk either with assistance or independently according to the motor milestone standard of the World Health Organization and all 25 were able to sit without support.
We note that Spinraza is already approved for the treatment of SMA in the United States, the European Union, and Japan. Biogen has submitted regulatory filings in additional countries and plans to initiate additional filings in other countries.
VistaGen Gains on Fast Track Designation to Pain Candidate: Shares of VistaGen (VTGN - Free Report) gained after the FDA granted Fast Track designation to its non-opioid pain candidate, AV-101. The company completed a phase I study evaluating the non-sedating candidate as an adjunct treatment for neuropathic pain. The candidate also enjoys Fast Track designation for the treatment of major depressive disorder (MDD), which was granted in December 2017. The company is currently evaluating AV-101 in a phase II study – ELEVATE – as a treatment for MDD in patients who have inadequate response when treated with a standard antidepressant therapy.
VistaGen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The NASDAQ Biotechnology index lost 4.27% over the last five trading sessions. Among the major biotech stocks, Celgene lost 5.5% in the last five trading sessions. Over the past six months, shares of Biogen have rallied 33.8%. (See the last biotech stock roundup here: Biotech Stock Roundup: ALXN on Acquisition Spree, FDA Nod for REGN, AMGN Drugs).
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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