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BioWorld - Tuesday, May 24, 2022
Home » Topics » Clinical

Clinical
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Close-up of elderly eye

Samsara Vision to initiate IDE trial of next-gen implant for late-stage AMD

April 27, 2022
By Meg Bryant
No Comments
Samsara Vision Inc. has received FDA approval to begin a U.S.-based PMA supplement trial to assess improvements in visual acuity and safety of its smaller-incision next-generation implantable miniature telescope, called SING IMT, in people with late-stage age-related macular degeneration (AMD). The device has been available in the EU since 2020.
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Shionogi releases positive results, back on track for COVID-19 treatment

April 27, 2022
By Gina Lee
No Comments
New trial results presented by Shionogi & Co. Ltd. at the 32nd European Congress of Clinical Microbiology and Infectious Diseases showed the company’s 3CL protease inhibitor, S-217622, was well-tolerated, with the potential to rapidly clear SARS-CoV-2, Simon Portsmouth, executive medical director at Shionogi, told BioWorld.
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Let it Rain: MDM2 data floodgates to open in year’s second half, space awash with players

April 27, 2022
By Randy Osborne
No Comments
Among the attention-getters at the American Association for Cancer Research meeting April 8-13 was protein-degradation specialist Kymera Therapeutics Inc., which made the preclinical case for its approach in murine double minute 2 (MDM2) research vs. an inhibitor. The MDM2 space has grown increasingly busy in recent years, with large and small biopharma concerns moving ahead with research in all phases of development.
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Clinical research concept with medical icons on light bulb

With positive phase III Tibsovo data, Servier and Cstone targeting AML

April 26, 2022
By Doris Yu
No Comments
Backed by fresh phase III data showing a combination of the IDH1 gene inhibitor Tibsovo (ivosidenib) and azacitidine significantly improved event-free survival and overall survival for adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) vs. azacitidine alone, Cstone Pharmaceuticals Co. Ltd. is working to bring the treatment to Chinese AML patients “as soon as possible,” a spokesperson told BioWorld.
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US booster study next after Arcturus’ self-amplifying mRNA COVID-19 vaccine hits endpoints

April 26, 2022
By Jennifer Boggs
No Comments
Arcturus Therapeutics Holdings Inc. reported that ARCT-154, its self-amplifying mRNA COVID-19 vaccine, showed efficacy of 55% against infection and 95% efficacy against severe disease, meeting the primary and key secondary endpoints of the ongoing phase I/II/III trial. While the company’s stock (NASDAQ:ARCT) regained much of its initial 25% drop to close the day, investors continue to await further data to determine where Arcturus’ vaccine will fit in with available COVID-19 vaccines.
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Large intestine illustration

Protagonist plays its own hero as it drives toward a phase III in ulcerative colitis

April 26, 2022
By Lee Landenberger
No Comments
Protagonist Therapeutics Inc. continues having a tough time. The latest is a steep stock drop after a phase II trial in ulcerative colitis (UC) missed its primary endpoint, but the company insists the data are good enough to move into phase III. Top-line data showed a 450-mg BID dose of PN-943 in treating moderate to severe UC missed its primary endpoint, which was the number of participants achieving clinical remission at week 12 compared to placebo.
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Clinical trial virtual display

Cancer and infectious disease top clinical reports, though volume falls

April 25, 2022
By Karen Carey
No Comments
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%.
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Eliem tanks on pipeline setbacks for pain, epilepsy drugs

April 25, 2022
By Jennifer Boggs
No Comments
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.
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Stock chart, upward arrow

Early CAR NK success in AML, NHL sends Nkarta stock on wild ride

April 25, 2022
By Randy Osborne
No Comments
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.
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Artery and plaque

Paclitaxel shows well again in PAD via Chocolate Touch device

April 22, 2022
By Mark McCarty
No Comments
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.
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