Today’s Daily Dose brings you news about aTyr Pharma joining the COVID-19 battle; Cara’s pivotal KALM-2 trial; LabCorp’s at-home collection kit for COVID-19 testing securing Emergency Use Authorization from the FDA, and Myovant’s much-awaited clinical trial catalyst.
aTyr Pharma Inc. (LIFE) is all set to initiate a phase II study of its drug candidate ATYR1923 in COVID-19 patients with severe respiratory complications.
The trial will enroll 30 confirmed COVID-19 positive patients at up to 10 centers in the United States and they will be assigned to one of three cohorts of 10 patients each. Patients will receive a single intravenous (IV) dose of either 1.0 or 3.0 mg/kg ATYR1923 or placebo.
In preclinical studies, ATYR1923 has been effective in downregulating T-cell responses, thereby dampening the inflammatory cytokine and chemokine signaling that has been implicated in severe COVID-19 cases. ATYR1923 has also been shown to improve lung function, as well as to reduce inflammation and fibrosis, in multiple animal models of immune-mediated acute lung injury, noted the Company.
LIFE closed Tuesday’s trading at $3.25, up 5.18%.
Cara Therapeutics Inc.’s (CARA) pivotal phase III trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus, dubbed KALM-2, has yielded positive results.
The trial achieved statistical significance in the primary efficacy endpoint of the proportion of patients achieving at least a three-point improvement from baseline in the weekly mean of the daily 24-hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score at week 12.
The proportion of patients on KORSUVA Injection achieving a three-point or greater improvement from baseline in the weekly mean of the daily 24 hour Worst Itching Intensity Numeric Rating Scale score at week 12 was 54% compared to 42% for patients on placebo.
There was also a statistically significant improvement in the key secondary endpoint of the proportion of patients with four-point or greater reduction in mean worst itching intensity NRS score vs. placebo.
The Company is planning to submit its New Drug Application for KORSUVA Injection in the second half of this year to the FDA. Cara’s partner Vifor Fresenius Medical Care Renal Pharma is expected to seek approval for KORSUVA Injection in Europe shortly thereafter.
CARA closed Tuesday’s trading at $15.42, up 4.05%.
LabCorp’s (LH) at-home collection kit for COVID-19 testing has been granted Emergency Use Authorization by the FDA.
The kits provide everything one needs to collect a nasal swab sample at home if recommended by a healthcare provider after completing a COVID-19 questionnaire.
According to the Company, the kits will be offered through its Pixel by LabCorp platform and initially be made available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic.
LH closed Tuesday’s trading at $148.18, up 1.76%.
Shares of Mirati Therapeutics, Inc. (MRTX) fell 10 percent on Tuesday, following a short report by KerrisdaleCapital, which doubts the Company’s investigational drug MRTX849, a small-molecule KRAS inhibitor, getting FDA approval as a single agent therapy in second-line non-small-cell lung cancer.
MRTX849 is under a phase I/II trial in patients with solid tumors expressing KRAS G12C mutations.
Last October, the Company announced the first clinical results from the phase I/II trial of MRTX849 in patients with solid tumors expressing KRAS G12C mutations. According to the Company, MRTX849 demonstrated clinical activity, including objective responses, in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
The report says that “MRTX-849 is a first-generation KRAS inhibitor that will quickly become obsolete even in the improbable scenario that it’s approved”.
MRTX closed Tuesday’s trading at $85.62, down 10.23%.
Myovant Sciences (MYOV) is slated to discuss results from its phase III study evaluating Relugolix combination therapy in women with pain associated with endometriosis, dubbed SPIRIT 2, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on Wednesday, April 22, 2020.
The Company will also discuss results from a separate ovulation inhibition study with Relugolix combination therapy.
In other news, Myovant announced the submission of a New Drug Application to the FDA for once-daily, oral Relugolix for the treatment of men with advanced prostate cancer.
MYOV closed Tuesday’s trading at $11.58, up 0.17%. In after-hours, the stock was up 10.28% at $12.77.
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