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BioWorld - Friday, September 22, 2023
Home » Topics » Clinical

Clinical
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Eiger scraps phase III but delta force deploying in hepatitis

Sep. 13, 2023
By Randy Osborne
No Comments
One hepatitis delta virus player (HDV) has dropped out after Eiger Biopharmaceuticals Inc.’s phase III effort with peginterferon lambda turned up safety issues, while others remain busy in a space highlighted during last November’s meeting of the American Association for the Study of Liver Diseases. Shares of Palo Alto, Calif.-based Eiger (NASDAQ:EIGR) closed Sept. 13 at 41 cents, down 28 cents, or 40.6%, on word that the company is stopping the Limt-2 study in patients with chronic HDV.
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Blood vessels

Humacyte’s phase II/III tissue graft data prompt talk of a BLA

Sep. 12, 2023
By Lee Landenberger
No Comments
Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The data showed higher rates of patency, a measure of the lack of vascular obstruction, when compared to synthetic graft benchmarks.
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Acelyrin’s izokibep misses primary HS goal on patient dropouts and perplexing placebo hikes

Sep. 12, 2023
By Caroline Richards
No Comments
Acelyrin Inc.’s shares tumbled after its interleukin-17A inhibitor, izokibep, failed to reach statistical significance in part B of a phase IIb/III trial in moderate to severe hidradenitis suppurativa (HS), but the company remains undeterred with its plans to advance the drug for the inflammatory skin condition.
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Kidneys and adrenal glands

Neurocrine win juices Spruce; CAH phase III ‘most difficult’ ever

Sep. 12, 2023
By Randy Osborne
No Comments
Neurocrine Biosciences Inc.’s positive top-line data from the phase III study called Cahtalyst in classic congenital adrenal hyperplasia (CAH) further whetted Wall Street’s appetite for soon-to-come results in the same indication from Spruce Therapeutics Inc.
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Jin Yanggon, chairman, HLB

KIW 2023: ‘HLB ready to take 50% of liver cancer market with rivoceranib’

Sep. 12, 2023
By Marian (YoonJee) Chu
No Comments
HLB Co. Ltd. is ready to take half of the liver cancer treatment market with its potential first-line treatment, rivoceranib, currently undergoing U.S. FDA review, company chairman Jin Yang-gon said, backed by positive survival data that beat out competitors by three months.
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Acromegaly diagnosis report, pills spilling out of bottles

No critics for Crinetics as paltusotine pill aces acromegaly endpoints in phase III

Sep. 11, 2023
By Caroline Richards
No Comments
The majority of patients with acromegaly who switched from therapy with injected somatostatin receptor ligands to Crinetics Pharmaceuticals Inc.’s once-daily, oral drug paltusotine maintained stable levels of insulin-like growth factor 1 in a phase III trial, moving the company’s first-in-class lead closer to becoming the potential new standard of care for the rare hormonal disorder.
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Lung cancer illustration

Daiichi Sankyo’s HER3 ADC shows promise in EGFR-mutated advanced NSCLC

Sep. 11, 2023
By Tamra Sami
No Comments
Daiichi Sankyo Co Ltd.’s HER3-directed antibody-drug conjugate patritumab deruxtecan showed clinically meaningful and durable responses in patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC) in the Herthena-Lung1 phase II trial.
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Liver disease

Cymabay phase III data solid in PBC; FDA Response time next focus

Sep. 8, 2023
By Randy Osborne
No Comments
Positive phase III data from Cymabay Therapeutics Inc. with seladelpar, the peroxisome proliferator-activated receptor for primary biliary cholangitis (PBC), could mean trouble for Intercept Pharmaceuticals Inc.’s second-line therapy, the farnesoid X receptor agonist Ocaliva (obeticholic acid), which Cymabay aims to replace with its compound as the preferred choice.
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Syringe and ampoules

Interim results show Brii’s therapeutic HBV vaccine induces immune response

Sep. 8, 2023
By Tamra Sami
No Comments
Brii Biosciences Ltd.’s therapeutic vaccine for hepatitis B (HBV), BRII-179 (VBI-2601), induced functional immune responses – inducing broad antibody and T-cell responses – in patients with chronic HBV in a phase II trial that evaluated the vaccine in combination with pegylated interferon-alfa, according to interim results.
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Corvus preps for randomized phase III for soquelitinib in PTCL

Sep. 7, 2023
By Karen Carey
No Comments
Shares of Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) sank 21.5% on Sept. 7, even though the company confirmed a phase III plan with the U.S. FDA for its ITK inhibitor, soquelitinib, to treat relapsed peripheral T-cell lymphoma (PTCL).
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