U.S. stocks fell on Wednesday, led by losses in financial stocks, on brewing tensions between the United States and Russia over a possible military action against Syria. Among the equities in focus today are biopharmaceutical company CymaBay Therapeutics (NASDAQ:CBAY), network security software maker VirnetX Holding (NYSEAMERICAN:VHC), and specialty pharmaceutical company Eyegate Pharmaceuticals (NASDAQ:EYEG).
CymaBay is a mover and shaker out on the Street today, with investors sparking the stock on an almost 10% upturn. Why the excitement? The company announced new positive data from a second interim analysis of its ongoing Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC).
These data demonstrate that in patients with PBC, seladelpar exhibits potent and sustained anti-cholestatic and anti-inflammatory efficacy over 26 weeks of administration. As of January 2018, 71 patients were exposed to at least one dose of seladelpar, of whom 53 received 12 weeks of treatment and 42 received 26 weeks of treatment. At baseline, mean alkaline phosphatase (AP) were 358, 333, and 262 U/L in the 2 mg, 5 mg, and 10 mg groups, respectively. At 12 weeks, changes in AP were -21%, -33%, and -45% in the 2 mg (N=6), 5 mg (N=25), and 10 mg (N=22) groups, respectively. After 12 weeks, dose titration was permitted for patients whose AP remained above normal and at a level where additional AP lowering had the potential to reduce the risk of disease progression. At 26 weeks, decreases in AP were similar across regimens at -45%, -43%, and -43% in the 5 mg (N=13), 5 to 10 mg titration (N=6) and 10 mg (N=19) groups, respectively. At 26 weeks, 69%, 67%, and 79% of patients across these three dose regimens, respectively, had an AP less than 1.67 times the upper limit of normal, with at least a 15% decrease in AP from baseline and normal bilirubin. Overall, 29% of patients had a normal AP at 26 weeks.
At 12 weeks, median transaminase changes were -9%, -28%, and -35% in the 2 mg, 5 mg, and 10 mg groups, respectively and decreases were maintained at 26 weeks in the 5 mg and 10 mg groups (≥ -40%).
Seladelpar was not associated with drug-induced pruritus. Baseline median pruritus VAS was 10 and 36 in the 5 mg and 10 mg groups, respectively, and patients in the 10 mg group experienced consistent decreases during treatment (-24% at week 26) suggesting potential anti-pruritic activity. Seladelpar was generally safe and well tolerated, with no transaminase elevation safety signal. There were 6 serious adverse events and none were deemed related to seladelpar.
Professor Hirschfield, from the University of Birmingham, UK, commented, “Seladelpar continues to demonstrate an impressive level of activity that is now sustained over 26 weeks of treatment. The decreased level of pruritus that was noted in the 10 mg group, a group that demonstrated a clinically relevant level of pruritus at baseline, is particularly intriguing and needs to be confirmed in additional studies.”
“We are thrilled to have the opportunity to share new data from our development of seladelpar for patients with PBC in a late-breaking presentation at The International Liver CongressTM. This is the third consecutive year in which seladelpar will be featured in the late-breaker category at one of the key international liver meetings. We have now firmly established doses of seladelpar with compelling efficacy and tolerability which we expect to further confirm in a Phase 3 study planned to start in the second half of the year,” said Dr. Pol Boudes, M.D., Chief Medical Officer of CymaBay. “These data continue to support the potential for seladelpar to significantly improve treatment options for patients with PBC. We are thankful for the commitment and dedication of the patients, PBC support groups, investigators and study coordinators who are all essential to our efforts to advance seladelpar for patients with PBC.”
VirnetX investors have some reasons to be optimistic today following the news that the company has won a unanimous $502.6 million patent infringement against Apple in the U.S. District Court for the Eastern District of Texas. VirnetX shares reacted to the news, skyrocketing nearly 14% in Wednesday trading session.
The 8-0 verdict handed down April 10 by a jury of five women and three men followed roughly three hours of deliberations. The seven-day trial focused on four VirnetX patents (U.S. Patent Nos. 6,502,135; 7,490,151; 7,418,504; and 7,921,211).
Jurors determined Apple’s attempted redesign fell short following a 2016 trial that ended with a separate jury finding that the company infringed VirnetX’s patents with the popular Facetime and VPN on Demand features used in the iPhone and other Apple products.
In the second phase of the trial, the same jury will be asked to determine whether Apple willfully infringed VirnetX’s patents. A decision in favor of VirnetX could leave Apple liable for increased damages.
Eyegate investors have a smile on their faces Wednesday, after the company announced that the United States Patent and Trademark Office (USPTO) has issued the Company a patent covering the utility of its iontophoretic contact lens. In reaction, Eyegate shares are soaring nearly 21% as of 1:26PM EDT.
“The issuance of this new patent represents a significant milestone in the development of our proprietary iontophoretic contact lens,” said Stephen From, President and Chief Executive Officer of EyeGate. “We believe that this technology, which could enable at-home administration of iontophoretic drugs, has the potential to significantly influence the future of ocular drug delivery by eliminating the need for intravitreal injections and reducing the number of doctor visits. We believe that the iontophoretic contact lens is particularly well-suited for the treatment of chronic retinal conditions, and have selected macular edema, which we believe is a large and underserved market, as our initial target indication.”
This is the first issued patent covering the iontophoretic contact lens. The patent relates to a multi-layer contact lens for ocular therapy, comprising a reservoir adapted to contain an electrically-charged therapeutic compound and an electrode providing iontophoretic current to the charged compound to propel it into the ocular tissue. The iontophoretic contact lens provides an easy, potentially improved technique for delivery of therapeutics to the retina.