AMRN Chugs Along, ATHX To Initiate Pivotal COVID-19 Trial, WORX Soars 550%
Today’s Daily Dose brings you news about Amarin’s preliminary Q1 revenue; Athersys’ initiation of a phase II/III pivotal study of MultiStem therapy in COVID-19-induced acute respiratory distress syndrome; Fennec Pharma’s regulatory catalyst in August; initial data of Gilead’s Remdesivir in COVID-19 trial and SCWorx’ receipt of a purchase order for two million COVID-19 Corona Virus IgM/IgG Rapid Testing Units.
Amarin Corporation plc (AMRN) during a conference call with management on Monday revealed that its preliminary estimate for the first quarter of 2020 is roughly $150 million, with the potential to be modestly higher. The total revenue in the first quarter of 2019 was $73.3 million.
The $150 million Q1 revenue mostly reflects VASCEPA sales in the U.S. VASCEPA was approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia in July 2012, and as an adjunct to statin therapy to reduce the risk of cardiovascular events in December 2019.
VASCEPA was launched in Canada in February of this year. The drug is under review in Europe and is expected to be approved near the end of this year.
A clinical trial for VASCEPA in China is underway, with results expected later this year. The Company said that the impact of COVID-19 is not expected to affect the timing of the results.
AMRN closed Monday’s trading at $6.39, up 5.62%.
Athersys Inc. (ATHX) has been given the go-ahead by the FDA to initiate a phase II/III pivotal study to assess the safety and efficacy of MultiStem therapy in subjects with moderate to severe acute respiratory distress syndrome (ARDS) induced by COVID-19.
The study, dubbed MACOVIA, is expected to be initiated this quarter.
MACOVIA is designed to enroll approximately 400 subjects and will be conducted at leading pulmonary critical care centers throughout the United States.
The primary efficacy endpoint will be the number of ventilator-free days through day 28 as compared to placebo. The secondary objectives of this study are to evaluate pulmonary function, all-cause mortality, tolerability and quality of life (QoL) among survivors associated with MultiStem therapy as a treatment for subjects with moderate to severe ARDS due to COVID-19, according to the Company.
ATHX closed Monday’s trading at $3.46, up 18.90%.
ASLAN Pharmaceuticals (ASLN) has paused recruitment of new patients in its phase I study of ASLAN004 in adults with moderate to severe atopic dermatitis in light of recently imposed government restrictions in Singapore to contain the spread of COVID-19.
The study is designed as a multiple ascending dose (MAD) escalation in up to 3 cohorts of patients, followed by a cohort expansion to further confirm the safety and tolerability of the selected dose, prior to advancing the compound in Phase 2 studies.
The Company noted that it intends to resume screening as soon as government restrictions are lifted, which is currently due to take place on 4 May 2020 and is taking steps to open sites in Australia by mid-year to accelerate recruitment.
The pausing of enrollment is not expected to affect the projected timelines for the readout of the trial, and the interim, unblinded data from all 3 dose cohorts in MAD study are expected to be reported in the third quarter of this year.
ASLN closed Monday’s trading at $1.59, up 33.61%.
Fennec Pharmaceuticals Inc.’s (FENC) (FRX.TO) New Drug Application for PEDMARK has been accepted for priority review by the FDA, with a decision expected on August 10, 2020.
PEDMARK is proposed for the prevention of hearing loss induced by Cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.
It is estimated that annually, over 10,000 children in the U.S. and Europe may receive platinum-based chemotherapy. Studies have shown that chemotherapy drug Cisplatin is associated with hearing loss in many patients.
PEDMARK, if approved, could be the first product for the prevention of Cisplatin-induced hearing loss in children.
FENC closed Monday’s trading at $7.23, up 11.92%.
Gilead Sciences Inc.’s (GILD) investigational antiviral Remdesivir has demonstrated clinical improvement in 68 percent of patients hospitalized with severe complications of COVID-19 in an international compassionate use study.
Of the 53 patients in the cohort, 34 were on mechanical ventilation at baseline, including four patients also on extracorporeal membrane oxygenation (ECMO). Treatment with Remdesivir resulted in an improvement in oxygen support class for 36 of the patients (68%) over a median follow-up of 18 days from the first dose of Remdesivir.
After 28 days of follow-up, the cumulative incidence of clinical improvement, defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-point scale was 84 percent according to Kaplan-Meier analysis. The overall mortality rate in this cohort was 13 percent (7/53).
Commenting on the compassionate use study results, Merdad Parsey, Chief Medical Officer, Gilead Sciences, said, “While the outcomes observed in this compassionate use analysis are encouraging, the data are limited.”
Gilead is conducting two Phase 3 clinical trials of Remdesivir – one in patients with severe COVID-19 disease, the data of which are expected this month, and another study in patients with moderate disease, whose data is expected in May.
GILD closed Monday’s trading at $75.28, up 2.41%.
Shares of SCWorx Corp. (WORX) touched a new 52-week high of $14.88 in intraday trading, soaring as much as 550%, before closing at $12.02, thanks to a committed purchase order from Rethink My Healthcare for two million COVID-19 Corona Virus IgM/IgG Rapid Testing Units.
The COVID-19 Corona Virus IgM/IgG Rapid Test is an in-vitro diagnostic test solely for the qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood, serum, plasma, and fingertip blood.
In the purchase order received from Rethink My Healthcare, a U.S.-based virtual healthcare network, besides the initial order for two million COVID-19 Rapid Testing Units, there is also provision for additional weekly orders of 2 million units for 23 weeks, valued at $35 million per week.
The Company is slated to host a business update conference call on Wednesday, April 15, 2020, at 11 am Eastern Time to discuss recent developments and provide a corporate update.
WORX closed Monday’s trading at $12.02, up 424.89%.
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