AbbVie’s Rinvoq shows positive action in ankylosing spondylitis study
A Phase 2/3 clinical trial, SELECT-AXIS 1, evaluating AbbVie’s (ABBV +3%) JAK inhibitor Rinvoq (upadacitinib) in adult patients with ankylosing spondylitis (AS) (a type of arthritis primarily affecting the spine) showed a treatment benefit. The results were presented at the American College of Rheumatology Annual Meeting in Atlanta.
The study met the primary endpoint of demonstrating a statistically significantly greater proportion of treated patients achieving ASAS40 (40% improvement in AS) at week 14 compared to placebo (52% vs. 26%; p<0.001).
Participants were naïve to biologic disease-modifying antirheumatic drugs and had failed to respond adequately to or were intolerant of nonsteroidal anti-inflammatory drugs (NSAIDs).
The FDA approved Rinvoq in August for rheumatoid arthritis. Late-stage studies in psoriatic arthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are in process.
Revive Therapeutics inks LOI to acquire cannabis-focused software developer
Revive Therapeutics (OTCQB:RVVTF +30.6%) has signed a non-binding letter of intent (LOI) to acquire GreenInsightz Limited, a developer of artificial intelligence software focused on the cannabis sector, via an amalgamation or other type of business combination.
GreenInsightz uses its patented technology to analyze social media datasets aimed at more effective targeting of cannabis users.
China on board with hemp, but not marijuana
Aiming to be a player in the global cannabidiol (CBD) market, China is moving quickly to ramp up production of cannabis, mainly hemp since it has been cultivated there for thousands of years.
The vast majority of production will be exported, however, due to strict regulations. For example, plants are not allowed to contain more than 0.3% THC, the psychoactive component of weed. CBD extraction facilities are outfitted with security cameras and are monitored by local police.
The production and availability of marijuana is a non-starter since authorities consider it a dangerous narcotic. Trafficking in THC can lead to a life sentence in prison or even the death penalty.
According the the Hemp Business Journal, China accounted for ~11% of the $800M global CBD market in 2018, trailing Europe and the U.S.
Celgene inks second collaboration deal with Skyhawk
Privately held Skyhawk Therapeutics enters into a second collaboration agreement with an affiliate of Celgene (CELG +0.4%) aimed at identifying targets in autoimmune disorders, oncology and immuno-oncology leveraging Skyhawk’s SkySTAR technology platform.
Under the terms of the agreement, Skyhawk will receive $80M upfront, milestones and royalties on net sales. Celgene will have options to exclusively license candidates discovered and developed under the partnership.
The parties inked their first deal in June 2018 for up to five programs.
Pfizer’s Xeljanz successful in pediatric arthritis study
Pfizer (NYSE:PFE) announces positive results from a Phase 3 clinical trial, A3921104, evaluating Xeljanz (tofacitinib) in pediatric patients (aged 2 to <18 years) with juvenile idiopathic arthritis (JIA). The results are being presented at the American College of Rheumatology Annual Meeting in Atlanta.
The study met the primary endpoint demonstrating a statistically significant reduction in the occurrence of disease flare at week 44 compared to placebo (disease flare was defined as at least a 30% worsening in at least three of the six variables of the JIA core set).
On the safety front, the most common adverse events in any treatment group were upper respiratory tract infection, headache, nasopharyngitis, nausea, pyrexia, disease progression, vomiting and JIA. There were no cases of death, major adverse cardiovascular events (MACE), malignancies, thrombosis, opportunistic infection or tuberculosis. There were two patients with herpes zoster and four patients with serious infections in the tofacitinib treatment arm throughout the course of the study.
The company plans to file a U.S. marketing application in 2020. The FDA first approved Xeljanz in November 2012 for adults with rheumatoid arthritis.