Welcome to another edition of "3 Things," a daily digest dedicated to helping you unearth important findings from the mountain of news coming out of pharma and biotech. As always, the main goal of this publication is to help get things on your radar that you may have normally missed in your due diligence.
So let's get right to it!
Novocure initiates a big study in pancreatic cancer
Device manufacturer Novocure (NASDAQ:NVCR) has made spectacular progress in the treatment of glioblastoma, as it attained approval for its wearable device that sends low-intensity electric fields through the brain in an attempt to target cancerous cells.
Not only does this approach work but also it actually appears to work better than standard chemotherapy and with less overall toxicity.
Now, NVCR is setting its sights on even bigger targets. It announced recently that the PANOVA-3 study design is being accelerated due to favorable results from PANOVA-2. The PANOVA suite is assessing the potential benefit of adding tumor-treating fields to one of two standard chemotherapy regimens for "locally advanced, unresectable" pancreatic cancer.
PANOVA-3 is looking to enroll 600 patients, with a primary endpoint of overall survival.
Looking forward: NVCR is getting aggressive in this space, and I like it a lot! PANOVA-2 results were really encouraging compared with historical data, and pancreatic cancer represents a major unmet need in oncology. If this novel treatment modality can make further progress for patients, it will be a big breakthrough. It's a morbid observation, but you can tell just how big an unmet need this is by the primary endpoint of overall survival. Normally, patients with advanced pancreatic cancer do not have a favorable prognosis, which makes the measurement of overall survival relatively simple. Hopefully, NVCR have on hand a great tool to help these patients.
Myovant also moves into late-stage studies for its endometriosis drug
Myovant Sciences (NYSE:MYOV) is a late-stage developmental biotech involved in research for gynecologic disorders. Its flagship compound in development is relugolix, a gonadotropin-releasing hormone receptor antagonist being assessed for uterine fibroids and endometriosis.
Last year, the company announced a licensing arrangement with Takeda Pharmaceuticals (OTCPK:TKPYY).
Now, MYOV and TKPYY have announced the initiation of two international phase 3 clinical trials, SPIRIT 1 and SPIRIT 2, to enroll around 600 patients each and compare relugolix with placebo for the treatment of endometriosis-related pain. Coprimary endpoints of these studies will be the proportion of women with a reduction in menstrual pelvic pain, as well as the proportion of women with reduction in non-menstrual pelvic pain, both assessed by questionnaires.
Looking forward: Endometriosis is a disease that often doesn't get quite the attention it should, and there has not been a new drug approval for this disease since 1997. Now, this class of agent is making a roaring debut, as illustrated by this news. MYOV isn't alone in late-stage development, though. AbbVie (NYSE:ABBV), partnered with Neurocrine (NASDAQ:NBIX), is also in phase 3 study with elagolix. However, this is likely to be a space that can accommodate the likes of MYOV, TKPYY, ABBV, and NBIX all together since it has been somewhat underappreciated by drug developers until recently.
Cara Therapeutics stumbles out of the gate in arthritic pain trial
Cara Therapeutics (NASDAQ:CARA) recently made big-time headlines with breakthrough designation for its drug called CR845 in the treatment of uremic pruritus, which is itching associated with chronic kidney disease. This indicates a certain level of confidence in the results seen by the FDA so far with CR845.
Unfortunately, it does not appear we can say the same in other indications. CARA announced negative top-line data for CR845 in the management of chronic pain due to osteoarthritis of the hip or knee. The primary endpoint of its placebo-controlled, phase 2b study was change in pain from baseline to eight weeks. The drug was tested at three dose levels.
Unfortunately, the first two dosing levels (1 mg and 2.5 mg daily) failed to yield an improvement in pain. However, patients who were able to maintain a 5 mg daily dose through the end of the eight-week period had a 39% reduction in pain, which was statistically significant.
Looking forward: Unfortunately, this trial was not the ripping success that CARA hoped for, though it was by no means a complete failure. It would appear that the company could continue progress through trials, increasing the dose intensity, which is what it plans to do, according to the conference call following these results. Importantly, the 5 mg dose was not associated with a lot of toxicity, so CARA could still have a winner on its hands in this area.
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