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Aridis (ARDS) Up After FDA Nod for Pneumonia Drug Study Design
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Aridis Pharmaceuticals (ARDS - Free Report) announced that the FDA has accepted the company’s proposal of a single confirmatory phase III AR-301-003 study of its proprietary monoclonal antibody candidate, AR-301, for treating pneumonia. The candidate is currently being developed as an adjunctive therapy to be implemented along with standard-of-care (SOC) antibiotics for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus (S. aureus) in mechanically ventilated hospitalized patients.
The agreement with FDA encompasses certain key details regarding the confirmatory phase III study, such as its design, which is required to support the submission of a biologics license application. Aridis has also reached an agreement with the FDA regarding the expansion plan of the study. The target patient group affected by S. aureus ventilator-associated pneumonia (VAP) shall include ventilated hospital-acquired pneumonia and ventilated community-acquired pneumonia patients.
The stock of the company skyrocketed 114.8% on Wednesday, following the encouraging news. In the year so far, shares of Aridis have plunged 66.3% compared with the industry’s 9.4% decline.
Image Source: Zacks Investment Research
In January 2023, Aridis reported positive top-line results from its first planned phase III AR-301-002 study evaluating the efficacy of AR-301 as adjunctive therapy along with SOC antibiotics compared with SOC antibiotics alone, in the treatment of VAP caused by Gram-positive bacteria S. aureus.
In the study, the primary endpoint of meaningful improvement in clinical cure rate (≥10%) was observed with adjunctive use of AR-301. However, Aridis reported that statistical significance was not reached for the primary endpoint on day 21, compared with antibiotics alone, due to the limited sample size evaluated. On day 21, 68.9% of patients achieved clinical cure in the cohort receiving AR-301 along with SOC antibiotics compared with 57.6% for SOC alone cohort.
The adjunctive therapy of AR-301 plus SOC antibiotics was found to be more effective in the older adult population (65+ years), where the clinical cure rate on day 21 increased to 34% and 38% on day 28. Aridis justifies this steep increase in clinical cure rate in the older population by the lower efficacy of SOC antibiotics compared with adults less than 65 years old.
Key secondary outcomes of reduction in duration of hospitalization, time in ICU and mechanical ventilation days were also achieved in the AR-301-002 study. AR-301 was overall well-tolerated in the study and demonstrated an acceptable safety profile, with no drug-related serious adverse events.
In the subsequent confirmatory phase III AR-301-003 study, the primary efficacy endpoint will also be the clinical cure rate of pneumonia on day 21, as used in the previous study, but will now be observed in older adults. This decision is pursuant to the observation made in the previous study, where the absolute efficacy is higher in older adults than in the overall population.
Key secondary efficacy outcomes, same as the previous study, will be observed in the overall population, i.e. ≥65 and <65 years of age.
VAP is a challenging disease in the hospital setting, with approximately 251,600 cases of hospital-acquired pneumonia reported in the United States, annually, caused by S. aureus. Patients are usually at high risk of mortality and also remain at risk of developing other life-threatening co-morbidities and a rise in antibiotic resistance.
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ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the year so far, shares of Akero Therapeutics have fallen by 18.7%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the year so far, shares of ADMA Biologics have gained 4.9%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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Aridis (ARDS) Up After FDA Nod for Pneumonia Drug Study Design
Aridis Pharmaceuticals (ARDS - Free Report) announced that the FDA has accepted the company’s proposal of a single confirmatory phase III AR-301-003 study of its proprietary monoclonal antibody candidate, AR-301, for treating pneumonia. The candidate is currently being developed as an adjunctive therapy to be implemented along with standard-of-care (SOC) antibiotics for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus (S. aureus) in mechanically ventilated hospitalized patients.
The agreement with FDA encompasses certain key details regarding the confirmatory phase III study, such as its design, which is required to support the submission of a biologics license application. Aridis has also reached an agreement with the FDA regarding the expansion plan of the study. The target patient group affected by S. aureus ventilator-associated pneumonia (VAP) shall include ventilated hospital-acquired pneumonia and ventilated community-acquired pneumonia patients.
The stock of the company skyrocketed 114.8% on Wednesday, following the encouraging news. In the year so far, shares of Aridis have plunged 66.3% compared with the industry’s 9.4% decline.
Image Source: Zacks Investment Research
In January 2023, Aridis reported positive top-line results from its first planned phase III AR-301-002 study evaluating the efficacy of AR-301 as adjunctive therapy along with SOC antibiotics compared with SOC antibiotics alone, in the treatment of VAP caused by Gram-positive bacteria S. aureus.
In the study, the primary endpoint of meaningful improvement in clinical cure rate (≥10%) was observed with adjunctive use of AR-301. However, Aridis reported that statistical significance was not reached for the primary endpoint on day 21, compared with antibiotics alone, due to the limited sample size evaluated. On day 21, 68.9% of patients achieved clinical cure in the cohort receiving AR-301 along with SOC antibiotics compared with 57.6% for SOC alone cohort.
The adjunctive therapy of AR-301 plus SOC antibiotics was found to be more effective in the older adult population (65+ years), where the clinical cure rate on day 21 increased to 34% and 38% on day 28. Aridis justifies this steep increase in clinical cure rate in the older population by the lower efficacy of SOC antibiotics compared with adults less than 65 years old.
Key secondary outcomes of reduction in duration of hospitalization, time in ICU and mechanical ventilation days were also achieved in the AR-301-002 study. AR-301 was overall well-tolerated in the study and demonstrated an acceptable safety profile, with no drug-related serious adverse events.
In the subsequent confirmatory phase III AR-301-003 study, the primary efficacy endpoint will also be the clinical cure rate of pneumonia on day 21, as used in the previous study, but will now be observed in older adults. This decision is pursuant to the observation made in the previous study, where the absolute efficacy is higher in older adults than in the overall population.
Key secondary efficacy outcomes, same as the previous study, will be observed in the overall population, i.e. ≥65 and <65 years of age.
VAP is a challenging disease in the hospital setting, with approximately 251,600 cases of hospital-acquired pneumonia reported in the United States, annually, caused by S. aureus. Patients are usually at high risk of mortality and also remain at risk of developing other life-threatening co-morbidities and a rise in antibiotic resistance.
Aridis Pharmaceuticals Price and Consensus
Aridis Pharmaceuticals price-consensus-chart | Aridis Pharmaceuticals Quote
Zacks Rank and Stocks to Consider
Aridis currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics (ALLO - Free Report) , Akero Therapeutics (AKRO - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.56 to $2.31. In the year so far, shares of Allogene Therapeutics have fallen by 16.6%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the year so far, shares of Akero Therapeutics have fallen by 18.7%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the year so far, shares of ADMA Biologics have gained 4.9%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.