AZN's COVID Shot 70% Effective On Average, ARQT Aces Scalp Psoriasis Study, BLRX' BLAST Fizzles

biotech nov24

Today's Daily Dose brings you news about the efficacy of AstraZeneca's COVID-19 vaccine candidate, Arcutis' results from phase IIb trial of ARQ-154 in scalp psoriasis, BioLineRx' BLAST study in acute myeloid leukemia, clinical hold imposed on Bellerophon's Phase III COVID-19 study, Kiniksa's date with FDA, and Merck adding a COVID-19 therapeutic candidate to its pipeline through an acquisition.

Read on…

1. AstraZeneca's COVID-19 vaccine candidate demonstrates average efficacy of 70%

AstraZeneca PLC's (AZN) COVID-19 vaccine candidate AZD1222 has demonstrated an average efficacy of 70%, based on pooled analysis of data from a phase II/III trial in the UK and a phase III trial in Brazil, involving a total of 11,636 patients.

In the phase II/III trial in the UK, dubbed COV002, where AZD1222 was given as a half dose, followed by a full dose at least one month apart, the efficacy was 90%. In the phase III trial in Brazil, dubbed COV003, where AZD1222 was administered as two full doses at least one month apart, the efficacy was 62%.

AZD1222, licensed from the Oxford University, contains the genetic material of the SARS-CoV-2 virus spike protein and it uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

AZD1222 is also under clinical testing in the U.S., Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the company expects to enroll up to 60,000 participants globally.

The vaccine can be stored, transported and handled at normal refrigerated conditions of 2 to 8 degrees Celsius for at least six months and administered within existing healthcare settings, according to the company.

AstraZeneca will begin preparations for seeking conditional or early approval from regulatory authorities and will also seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.

Last week, Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced that their COVID-19 vaccine candidate BNT162b2 demonstrated an efficacy of 95%, when given as a two-dose regimen, 21 days apart. The companies filed for emergency use authorization for BNT162b2 with the FDA on November 20.

Moderna Inc's (MRNA) COVID-19 vaccine candidate has demonstrated an efficacy of 94.5% in its phase III trial. The European Medicines Agency has begun rolling review of mRNA-1273. The company is reportedly planning to file for Emergency Use Authorization with the FDA before the end of this month.

AZN closed Monday's trading at $54.70, down 1.08%.

2. Arcutis' Scalp Psoriasis Trial Achieves All Goals

Arcutis Biotherapeutics Inc.'s (ARQT) phase IIb trial evaluating ARQ-154 as a potential treatment for scalp psoriasis in adult and adolescent patients achieved primary endpoints as well as multiple secondary endpoints.

ARQ-154 is Roflumilast foam that is designed to be applied topically once daily.

Scalp psoriasis is a manifestation of plaque psoriasis characterized by raised, red areas of skin ("plaques") covered with a silver or white scale that occurs in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Approximately 40 percent of the estimated 8.6 million Americans with psoriasis have involvement of the scalp.

The primary endpoint of the trial, i.e., the Scalp Investigator Global Assessment (S-IGA) success rate assessed at week 8, was 59.1% in the Roflumilast foam 0.3% arm compared to 11.4% in the vehicle arm. S-IGA success is defined as the achievement of an S-IGA score of 'clear' or 'almost clear' on a 5-grade scale plus at least a two-point change from baseline.

The trial also met key secondary endpoints like Body Investigator Global Assessment (B-IGA) success assessed at week 8, and symptomatic improvement.

ARQT closed Monday's trading at $25.18, up 8.91%.

3. BioLineRx' BLAST Study in acute myeloid leukemia Fizzles

Shares of BioLineRx Ltd. (BLRX) plunged more than 13% on Monday, following disappointing news related to its BLAST study.

BLAST is a phase IIb study evaluating the efficacy of Motixafortide (formerly BL 8040) addition to consolidation therapy in acute myeloid leukemia (AML) patients. The company has decided to terminate the trial as it has not demonstrated statistically significant effect in primary endpoint.

The company has a couple of catalysts to watch out for in the coming months.

-- The full results, including progression free survival (PFS) and overall survival (OS) data, from a phase IIa study of Motixafortide in combination with Keytruda and Chemotherapy in patients with Metastatic Pancreatic Adenocarcinoma are expected to be reported by the end of this year.

-- A phase III trial of Motixafortide for stem cell mobilization (SCM) in multiple myeloma patients, dubbed GENESIS is underway, with final results expected in the first half of 2021.

-- Preliminary results from a phase Ib study of Motixafortidel in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections are expected in the first half of 2021.

-- Initial results from Part 2 of a phase I/IIa trial of AGI-134 in solid tumors are anticipated in the second half of 2021.

BLRX closed Monday's trading at $2.28, down 13.6%.

4. Bellerophon Puts Phase III COVID-19 Study on Hold

Bellerophon Therapeutics Inc. (BLPH) has put on clinical hold its phase III study of INOpulse for the treatment of COVID-19, following the recommendation of the independent Data Monitoring Committee.

The phase III study, dubbed COViNOX , has recruited close to 200 patients, of which 100 were included in the interim analysis. The interim analysis was limited to the evaluation of safety and a single efficacy endpoint of respiratory failure or death. The independent Data Monitoring Committee's recommendation to put the trial on hold was based on the interim analysis results.

BLPH closed Monday's trading at $7.22, down 17.77%.

5. Kiniksa Pharma to Face FDA in March

Kiniksa Pharmaceuticals Ltd.'s (KNSA) supplemental Biologics License Application for Rilonacept in treating recurrent pericarditis has been accepted for priority review by the FDA, with a decision expected on March 21, 2021.

Rilonacept was discovered and developed by Regeneron Pharmaceuticals Inc. (REGN) and is already approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes under the brand name ARCALYST.

Kiniksa licensed Rilonacept from Regeneron in 2017 for evaluation in certain diseases, including recurrent pericarditis.

An aggregate amount of $27.5 million is payable by Kiniksa to Regeneron through the time of a potential approval of Rilonacept in recurrent pericarditis - with $7.5 million expected to be paid in the fourth quarter of 2020.

KNSA closed Monday's trading at $15.50, up 4.17%.

6. Merck Adds COVID-19 therapeutic candidate to Pipeline

Merck (MRK) will be adding a COVID-19 therapeutic candidate to its pipeline, following a deal to acquire OncoImmune, a privately-held, clinical-stage biopharmaceutical company, for $425 million in cash.

Besides the upfront cash payment, OncoImmune shareholders will be eligible to receive sales-based payments and payments contingent on the successful achievement of certain regulatory milestones.

In September, OncoImmune announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating its lead therapeutic candidate SACCOVID for the treatment of patients with severe and critical COVID-19. According to the trial results, patients who received SACCOVID had a 60% better chance to achieve clinical recovery than those who received placebo.

The acquisition is expected to close before the end of 2020.

MRK closed Monday's trading at $80.28, down 0.21%.

7. Stocks Hitting New Highs/Lows

Graybug Vision Inc. (GRAY) closed Monday's trading at an all-time high of $33.93, up 22.89%.

Olema Pharmaceuticals, Inc. (OLMA) closed at an all-time high of $52.78, up 7.93%.

TRACON Pharmaceuticals Inc. (TCON) closed at a 52-week high of $9.04, up 7.62%.

PolarityTE Inc. (PTE) closed at an all-time low of $0.67, down 27.06%.

Progenity Inc. (PROG) closed at an all-time low of $3.64, down 7.14%.

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