Today’s Daily Dose brings you news about Lilly temporarily halting phase III trial of COVID-19 antibody, Gossamer Bio’s oral GB001 flunking in both asthma and chronic rhinosinusitis trials, encouraging data from Regeneron/Sanofi’s Dupixent trial, and Johnson & Johnson’s rosy outlook.
1. Lilly Pauses Phase III trial of COVID-19 Antibody
A phase III trial evaluating Eli Lilly and Co.’s (LLY) investigational monoclonal antibody LY-CoV555 in combination with standard of care Gilead SciencesInc.’s (GILD) Remdesivir in hospitalized COVID-19 patients has been paused due to a potential safety concern, according to reports.
Launched in August, the phase III study, dubbed ACTIV-3, was initially designed to enroll about 300 volunteers who have been hospitalized with mild to moderate COVID-19 and is led by the National Institutes of Health.
Another NIH-led phase III study of LY-CoV555, dubbed ACTIV-2, is ongoing in patients with mild to moderate symptoms of COVID-19 who have not been hospitalized.
Last week, Lilly had submitted an initial request for emergency use authorization for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19 based on data from an interim analysis of another trial, dubbed BLAZE-1, which is a phase II study.
It is not known whether the pausing of the ACTIV-3 study will impact the other ongoing LY-CoV555 trials.
On Monday, Johnson & Johnson (JNJ) announced that it is temporarily suspending a phase III study of its COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant.
In September, AstraZeneca plc’s (AZN) phase III trial of COVID-19 vaccine candidate, AZD1222, which was underway in the U.S., UK, Brazil, South Africa, and other countries, was put on hold over a safety issue. While the phase III trial has resumed in other countries now, it continues to remain on hold in the U.S.
LLY closed Tuesday’s trading at $150.08, down 2.85%.
2. Double Whammy for Gossamer as GB001 Fails In Two Trials
Shares of Gossamer Bio Inc. (GOSS) plunged more than 25% on Tuesday, following disappointing data from its phase II trials of oral GB001 in asthma and chronic rhinosinusitis.
In a phase IIb trial of oral GB001 in patients with moderate-to-severe eosinophilic asthma, dubbed LEDA, the primary endpoint of asthma worsening was not met. However, statistically significant improvements in the secondary endpoint of time to first asthma worsening compared to placebo were observed.
The company noted that it will discuss its findings related to oral GB001 in asthma with global regulatory authorities and continue discussions with potential strategic partners.
In a phase IIa trial of oral GB001 in patients with chronic rhinosinusitis with and without nasal polyps, dubbed TITAN, the primary endpoint of change from baseline in *SNOT-22 score at Week 16, and the secondary endpoint of change from baseline to Week 16 in nasal polyp score were not met. (*SNOT-22 or Sino-Nasal Outcome Test is a validated questionnaire that assesses patients with chronic rhinosinusitis).
The company has decided not to pursue the development of GB001 in chronic rhinosinusitis.
GOSS closed Tuesday’s trading at $10.09, down 25.75%.
3. JNJ Boosts Annual Outlook
Johnson & Johnson (JNJ), which reported better-than-expected third-quarter financial results on Tuesday, has boosted its outlook for full-year 2020.
On an adjusted basis, net earnings for the third quarter of 2020 rose to $5.87 billion or $2.20 per share from $5.67 billion or $2.12 per share in the year-ago quarter. On average, Wall Street analysts expected earnings of $1.98 per share.
Sales for the recent third quarter were $21.08 billion compared to $20.73 billion in the same quarter last year and well above analysts’ consensus estimate of $20.20 billion.
Looking ahead, the company now expects operational sales to range between $82.0 billion and $82.8 billion, up from its prior forecast range of $81.0 billion and $82.5 billion. The consensus estimate for sales predicted by Wall Street analysts for the year is $81.03 billion.
JNJ closed Tuesday’s trading at $148.36, down 2.29%.
4. Regeneron/Sanofi’s Cash Cow Dupixent Does It Again!
Regeneron Pharmaceuticals Inc. (REGN) and Sanofi’s (SNY) pivotal phase III trial of Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma has met its primary and all key secondary endpoints.
Despite standard-of-care therapy such as inhaled corticosteroids, children with uncontrolled moderate-to-severe asthma are said to be at risk of severe asthma attacks and this often leads to frequent hospitalizations and emergency room visits.
In the phase III trial, dubbed LIBERTY ASTHMA VOYAGE, Dupixent significantly reduced severe asthma attacks by up to 65% over one year compared to placebo. In addition, the drug was associated with a significant and rapid improvement in lung function within two weeks and it was sustained for up to 52 weeks.
Commenting on the trial results, John Reed, Global Head of Research and Development at Sanofi, said, “Dupixent is the only biologic shown in a controlled Phase 3 trial to improve lung function in children, which is generally consistent with results seen in the adolescent and adult trials”.
The companies are planning to make U.S. and EU regulatory submissions, seeking approval for Dupixent for children aged 6-11 years with uncontrolled moderate-to-severe asthma, by the first quarter of 2021.
Dupixent is already approved for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis, as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older and as an add-on maintenance treatment in adult patients with chronic rhinosinusitis with nasal polyposis.
The drug recorded annual sales of $2.32 billion in 2019. SVB Leerink analyst Geoffrey Porges expects Dupixent to bring in sales of $3.86 billion in 2020.
REGN closed Tuesday’s trading at $607.98, up 1.07%.
5. Stocks That Moved On No News
Aethlon Medical Inc. (AEMD) closed Tuesday’s trading at $1.97, up 33.11%.
SOS Limited (SOS) closed Tuesday’s trading at $2.69, up 27.49%.
BiondVax Pharmaceuticals Ltd. (BVXV) closed Tuesday’s trading at $40.79, up 19.90%.
Liquidia Technologies, Inc. (LQDA) closed Tuesday’s trading at $4.08, down 29.53%.
Avenue Therapeutics Inc. (ATXI) closed Tuesday’s trading at $3.87, down 14.57%.
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