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Home » Topics » Clinical

Clinical
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Inflammation in big toe

LG Chem, JW Pharma go toe-to-toe in Asia gout drug race

Aug. 21, 2023
By Marian (YoonJee) Chu
South Korean pharmaceutical firms LG Chem Ltd. and JW Pharmaceutical Corp. are recouping and pressing on with their respective novel gout drugs internationally, with each having faced regulatory setbacks from IND rejections overseas.
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Liver illustration

Delcath gets FDA win for Hepzato Kit for metastatic uveal melanoma

Aug. 16, 2023
By Meg Bryant
Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.
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Clinical data illustration

Adalta gears up for phase II IPF trials for its i-body derived from shark antibodies

Aug. 15, 2023
By Tamra Sami
Adalta Ltd. is gearing up to begin phase II trials of its lead i-body candidate, AD-214, in idiopathic pulmonary fibrosis (IPF), but it is hoping to find a pharma partner to fund the trials.
Read More
Dividing breast cancer cell.

Kelun’s Trop2 ADC meets primary endpoints in phase III triple-negative breast cancer trial

Aug. 15, 2023
By Tamra Sami
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis.
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Excipient incipient, Design maligned; new formulation underway for FA therapy

Aug. 15, 2023
By Randy Osborne
Variable muscle expression of frataxin (FXN) protein in muscle plus five adverse events (AEs) of injection-site thrombophlebitis in the multiple ascending-dose (MAD) phase I study hamstrung Design Therapeutics Inc. in its Friedreich’s ataxia (FA) bid with DT-216. Wall Street punished the Carlsbad, Calif.-based firm’s stock (NASDAQ:DSGN) with a knockdown of 70%, or $5.17, leaving shares at $2.17 when the market closed Aug. 15.
Read More
Lungs

Galecto stock craters on phase IIb miss in IPF

Aug. 15, 2023
By Cormac Sheridan
Shares in Galecto Inc. (NASDAQ:GLTO) plummeted by 71%, closing Aug. 15 at 67 cents, on news that its lead drug candidate, GB-0139, flamed out in a phase IIb trial in idiopathic pulmonary fibrosis (IPF). The inhaled galectin-3 inhibitor actually performed considerably worse than placebo in the 52-week placebo-controlled study, the endpoint of which was the annual rate of decline from baseline in forced vital capacity (FVC). 
Read More
Dividing breast cancer cell.

Kelun’s Trop2 ADC meets primary endpoints in phase III triple-negative breast cancer trial

Aug. 14, 2023
By Tamra Sami
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis. The randomized, controlled, open-label, multicenter phase III trial compared injectable SKB-264 (also known as KL-A264 and MK-2870) vs. investigator-selected regimens in patients who failed second-line or above prior standard-of-care therapies.
Read More

Terns’ pair-shaped THR-B prospect bears fruit in NASH as monotherapy, too

Aug. 9, 2023
By Randy Osborne
Terns Pharmaceuticals Inc.’s unveiled positive top-line data from the phase IIa Duet study testing TERN-501, an oral thyroid hormone receptor-beta (THR-B) agonist, given as a monotherapy or in combination with TERN-101, a liver-distributed farnesoid X receptor agonist, for the treatment of nonalcoholic steatohepatitis (NASH).
Read More
Stomach and intestine

Palisade shares wither with phase II failure

Aug. 9, 2023
By Lee Landenberger
With a phase II failure, Palisade Bio Inc. has decided to halt development into one of two indications for its only asset, LB-1148. The oral formulation of a broad-spectrum serine protease inhibitor missed the primary endpoint in the Profile study of reducing intra-abdominal adhesions after bowel resection. Palisade said the safety data and efficacy results no longer support further development of LB-1148 in the indication.
Read More
Woman scratching hives on shoulder

Phase III readout with Novartis’ chronic hives contender offers s-liver of hope for BTK class

Aug. 9, 2023
By Caroline Richards
There have been no signs of liver damage with Novartis AG’s oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib for treating chronic spontaneous urticaria, top-line results from two phase III trials show, suggesting that faith in the faltering BTK space could be restored.
Read More
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