More than a quarter of all clinical data reported this year are targeting cancer indications, as pandemic news dips and overall activity drops by 12.5%.
Shares of Eliem Therapeutics Inc. fell 56% on the company’s announcement that it would end development of its non-opioid palmitoylethanolamide prodrug, ETX-810, in diabetic peripheral neuropathic pain following a phase IIa failure. It was part of a double dose of bad news reported by Seattle-based Eliem, which also is delaying phase II development of depression candidate ETX-155 to resolve issues of lower-than-expected drug exposure in a phase I study of the neuroactive steroid GABAA receptor positive allosteric modulator in photosensitive epilepsy.
After rolling out positive, preliminary phase I CAR natural killer cell data, Nkarta Inc. saw its stock (NASDAQ:NKTX) soar to $18.72, up $10.95, or 140.9%, as Wall Street made known its pleasure in results from the small, independent dose-finding studies with Nkarta’s two off-the-shelf lead candidates, NKX-101 and NKX-019, in two groups of blood cancer patients: those with relapsed/refractory (r/r) acute myeloid leukemia (AML) and with r/r non-Hodgkin lymphoma (NHL), respectively.
The days when paclitaxel was the subject of controversy in connection with peripheral artery disease (PAD) seem to be drawing to a close, thanks in part to a new drug-coated balloon (DCB) by Trireme Medical Inc., of Pleasanton, Calif. Trireme’s Chocolate Touch device, a second-generation DCB with paclitaxel as an antiproliferative, fared well against a legacy paclitaxel device, thus opening a new front in the competition in the PAD space and seemingly relieving any concerns about the safety of paclitaxel.
Toosonix A/S has launched two trials as it moves to gather data enabling its high-intensity focused ultrasound (HIFU) device to get approval for use in clinical dermatology indications. The company reported on April 19 that the first patients have been treated in a trial of its System One-M device in treating basal cell carcinoma (BCC). Meanwhile, the first patient has been cleared for treatment on April 28 in a study in neurofibromatosis, an inherited condition that causes benign tumors to form on the skin.
Isofol Medical AB’s slow reveal of data from its phase III registration trial of arfolitixorin in first-line metastatic colorectal cancer (mCRC) will not reach a conclusion until the fourth quarter of this year. The news follows a December 2021 warning to investors that an unexplained level of therapy switches occurring in the absence of disease progression would impair its analysis of a key secondary endpoint, the rate of progression-free survival.
After August 2021 news from the U.S. FDA of deficiencies in the NDA that Axsome Therapeutics Inc. submitted for AXS-05 in major depressive disorder (MDD), word was especially welcome April 19 that the firm has come to an agreement with the agency with regard to post-marketing requirements. Meanwhile, another player in MDD, Relmada Therapeutics Inc., is due to report phase III data with REL-1017 (esmethadone) around the middle of this year.
By January 2022, 12 billion COVID-19 vaccine doses had been manufactured and, to date, roughly 20 vaccines have received either full approval or emergency use authorization in countries around the world. In places such as Europe and the U.S., most of the people who want vaccinations have gotten their jabs. And the vaccines continue to show efficacy, with the latest CDC data showing consistently less risk for testing positive for COVID-19 or dying from the infection for those who are vaccinated and boostered. Yet the development of new COVID-19 vaccines remains surprisingly robust, with BioWorld tracking 258, the majority of which are in preclinical development.
Alexion Pharmaceuticals Inc. has demonstrated the commercial potential for rare disease drugs with its complement inhibitor Soliris (eculizumab) and long-lasting follow-up Ultomiris (ravulizumab) driving blockbuster sales. A host of other companies are hoping to compete with Ultomiris, which is U.S. FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Astrazeneca plc led the handful of firms rolling out COVID-19-related news, as the company said detailed results from the Provent phase III pre-exposure prophylaxis (prevention) trial with Evusheld (tixagevimab and cilgavimab), were published in the New England Journal of Medicine, the “culmination of about 19 months of pretty intensive work,” said Mark Esser, vice president of microbial sciences.
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