AGIO’s ACTIVATE-T Hits Goals, EDSA Catches Eye, JNJ Provides Rosy Outlook, VXRT On Watch

Today’s Daily Dose brings you news about the progress of Vaxart’s oral tablet COVID-19 vaccine candidate; Vir Biotech’s phase I trial of VIR-3434 in chronic hepatitis B virus; Sorrento’s COVID-19 program; Agios Pharma’s phase III trial of Mitapivat and Johnson & Johnson’s rosy outlook for 2021.

Read on…

1. Agios’ Mitapivat Shows Promise in ACTIVATE-T Study

Agios Pharmaceuticals Inc’s (AGIO) phase III trial of Mitapivat in regularly transfused adults with Pyruvate Kinase deficiency has achieved the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in transfusion burden.

In the 24-week study, dubbed ACTIVATE-T, twenty seven patients were enrolled, all of whom were treated with Mitapivat. At the end of the study period, 37 percent achieved a ‘more than or equal to 33%’ reduction in transfusion burden and 22% were transfusion-free.

The company expects to seek regulatory approval for Mitapivat for the treatment of adults with Pyruvate Kinase (PK) deficiency in the U.S. next quarter and in the EU in mid-2021.

AGIO closed Tuesday’s trading at $48.04, down 2.95%.

2. Edesa to Explore Potential of EB05 in ARDS

Edesa Biotech Inc. (EDSA) has received clearance from the FDA and Health Canada to add a sub-study to its ongoing phase II/III clinical study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients.

The sub-study will evaluate use of EB05 as a potential rescue therapy for critically severe COVID-19 cases. This study is designed to enroll up to 100 ICU patients with severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy.

The ongoing international Phase 2/3 study that is evaluating the efficacy and safety of EB05 in adult hospitalized COVID-19 patients will continue without any changes.

EDSA closed Tuesday’s trading at $7.48, up 35.26%.

3. JNJ Offers Rosy Outlook For 2021

Shares of Johnson & Johnson (JNJ) touched a new high on Tuesday, following its rosy outlook for 2021.

The company has forecast its annual earnings per share for 2021 in the range of $9.40 to $9.60 and annual sales to range between $90.5 billion to $91.7 billion. The earnings for full year 2020 were $5.51 per share and sales were $82.58 billion.
Analysts polled by Thomson Reuters expect the company to earn $9.06 per share on sales of $89.25 billion for 2021.

JNJ closed at a new high of $170.48, up 2.71%.

4. Regeneron’s antibody cocktail Proves Effective as passive Covid -19 Vaccine

Regeneron Pharmaceuticals Inc.’s (REGN) ongoing phase III clinical trial of REGEN-COV used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection has produced positive initial results.

REGEN-COV, which is an antibody cocktail of Casirivimab and Imdevimab, reduced overall infections by 50% within first week, and demonstrated 100% prevention of symptomatic infections. The antibody cocktail also markedly decreased levels and duration of viral shedding in asymptomatic infections that still occurred in REGEN-COV group. While infections in the REGEN-COV group lasted no more than 1 week, approximately 40% of infections in the placebo group lasted 3-4 weeks.

In addition to the phase III trial for the prevention of COVID-19, REGEN-COV is being studied in two late-stage hospitalized patient trials and a phase III trial for the treatment of non-hospitalized patients.

REGN closed Tuesday’s trading at $544, down 0.75%.

5. Sorrento Reports Promising Results of COVI-MSC

Sorrento Therapeutics Inc.’s (SRNE) ongoing phase 1b study of human allogeneic adipose-derived mesenchymal stem cells, COVI-MSC, for patients suffering from COVID-19-induced acute respiratory distress (ARD) or acute respiratory distress syndrome (ARDS) has yielded positive results.

As part of the treatment, COVI-MSC was administered every other day for three infusions for a total of 1 x 106 cells/kg.

The first three patients treated with COVI-MSC were discharged from the hospital within a week of starting COVI-MSC infusions and two patients were discharged on the day of their last infusion. One of the patients had been in the hospital for three weeks, unable to be weaned from significant oxygen support, and another patient with uncontrolled diabetes had been discharged previously but had to be readmitted due to recurrent ARD, added the company.

SRNE closed Tuesday’s trading at $10.42, up 12.28%.

6. Vaxart to Unveil Study Results of Oral Tablet COVID-19 Vaccine Next Week

Vaxart Inc. (VXRT) is expected to release data from its phase I study of VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate, next week.

According to new pre-clinical histology data announced yesterday, hamsters that received two doses of the oral tablet vaccine had a substantial reduction in lung inflammation as compared to unvaccinated hamsters. Results reported from the Hamster Challenge Study last November showed a 4-to 5-fold log reduction in lung viral load in hamsters that received two oral vaccine doses compared to non-vaccinated animals.

VXRT closed Tuesday’s trading at $9.38, down 6.67%.

7. Vir Touches New High on HBV Trial Data

Shares of Vir Biotechnology Inc. (VIR) jumped over 70% on Tuesday to touch a new high, following encouraging initial topline data from its ongoing phase I trial of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection.

The first cohort of the trial involved eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434. The 6 patients treated with VIR-3434 achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight.

Phillip Pang, M.D., Ph.D., Chief Medical Officer of Vir, said, “Extrapolating from our preclinical data, we expected it might require much higher doses of VIR-3434 to achieve this level of HBsAg knockdown. To have achieved it with a dose of 6 mg is unexpected.”

A phase II trial combining VIR-3434 with another drug candidate VIR-2218 is expected to commence in the second half of this year.

VIR closed Tuesday’s trading at $77.38, up 74.32%.

8. Stocks That Gained/Lost the Most In A Day

AIkido Pharma Inc. (AIKI) closed Tuesday’s trading at $1.79, up 46.72%.

BIOLASE Inc. (BIOL) closed at $1.50, up 44.23%.

Conversion Labs Inc. (CVLB) closed at $17.72, up 37.68%.

Capricor Therapeutics Inc. (CAPR) closed at $6.35, down 17.53%.

Repro Med Systems Inc. (KRMD) closed at $4.33, down 15.59%.

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