Upper respiratory tract infection

Incyte Announces Results from SCRATCH-AD Trial Demonstrating Substantial and Rapid Itch Reduction in Patients with Mild-Moderate Atopic Dermatitis Treated with Opzelura® (ruxolitinib) Cream

Retrieved on: 
Monday, May 1, 2023

These data were featured in a poster presentation (Poster #396) at the Revolutionizing Atopic Dermatitis (RAD) Conference, held from April 29-May 1 in Washington, D.C.

Key Points: 
  • These data were featured in a poster presentation (Poster #396) at the Revolutionizing Atopic Dermatitis (RAD) Conference, held from April 29-May 1 in Washington, D.C.
  • Results showed that patients with AD treated with Opzelura experienced a rapid and substantial improvement in itch, which was sustained and further improved through 28 days of treatment.
  • "We are pleased that the SCRATCH-AD results further emphasize the rapid impact of Opzelura on itch reduction and reinforce its profile as an effective, well-tolerated topical non-steroidal treatment for AD."
  • “I am encouraged by these results showing rapid and substantial itch reduction among AD patients treated with Opzelura, and its potential to quickly alleviate this burdensome symptom for patients.”

Achieve Life Sciences Announces Positive Phase 2 ORCA-V1 Trial Results Showing Statistically Significant Vaping Cessation Benefit for Participants Treated with Cytisinicline

Retrieved on: 
Thursday, April 20, 2023

SEATTLE and VANCOUVER, British Columbia, April 20, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today reported positive topline results from its Phase 2 ORCA-V1 trial. ORCA-V1 evaluated the efficacy and safety of 3mg cytisinicline dosed three times daily for 12 weeks compared to placebo in 160 adults who use e-cigarettes or nicotine vapes and who do not currently smoke cigarettes. All participants received behavioral support for nicotine cessation.

Key Points: 
  • The vaping cessation rate during weeks 9-12 was 31.8% for cytisinicline compared to 15.1% for placebo.
  • A benefit in favor of cytisinicline was consistently observed across the secondary endpoints.
  • Additionally, a cessation benefit was observed for cytisinicline across clinical trial sites and participant demographics such as age, gender, race, or whether they had smoked cigarettes in the past.
  • The content is the sole responsibility of the authors and does not necessarily represent the official views of the NIH.

Avalyn Pharma Publishes Phase 1b ATLAS Results Demonstrating Stabilization of Lung Function at 24 and 48 Weeks with AP01 and Favorable Safety Profile

Retrieved on: 
Thursday, March 23, 2023

The study assessed safety and efficacy of AP01 (inhaled pirfenidone) in adults with idiopathic pulmonary fibrosis (IPF) through 72 weeks.

Key Points: 
  • The study assessed safety and efficacy of AP01 (inhaled pirfenidone) in adults with idiopathic pulmonary fibrosis (IPF) through 72 weeks.
  • Efficacy and safety results at weeks 24 and 48 are also reported.
  • “While oral pirfenidone has the potential to improve lung function by reducing fibrosis, its utility is limited by its poor tolerability profile,” explained Lyn Baranowski, Avalyn’s CEO .
  • “Although the ATLAS study's primary endpoint was safety, secondary measures of efficacy showed a trend towards disease stabilization in participants with IPF who administered high-dose AP01.

New Four-Year Data for Genentech’s Evrysdi Reinforce Long-Term Efficacy and Safety Profile in Some of the Most Severely Affected People With Types 2 and 3 Spinal Muscular Atrophy (SMA)

Retrieved on: 
Monday, March 20, 2023

Participants also reported continuous improvement or stabilization when independently performing activities of daily living such as picking up and moving objects.

Key Points: 
  • Participants also reported continuous improvement or stabilization when independently performing activities of daily living such as picking up and moving objects.
  • The data were presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, March 19-22, 2023.
  • “Preserving long-term independence and the ability to perform daily tasks is an important measure for people living with SMA and their caregivers.
  • Genentech is currently investigating Evrysdi in combination with an anti-myostatin molecule targeting muscle growth in the Phase II/III trial MANATEE for the treatment of SMA.

LEO Pharma Presents Late-Breaking Positive Phase 2a Efficacy and Safety Results of LEO 138559 in Moderate-to-Severe Atopic Dermatitis at the 2023 AAD Annual Meeting

Retrieved on: 
Saturday, March 18, 2023

LEO Pharma A/S, a global leader in medical dermatology, today announced that a Phase 2a trial evaluating the efficacy and safety of investigational agent LEO 138559 in adults with moderate-to-severe atopic dermatitis met its primary endpoint.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced that a Phase 2a trial evaluating the efficacy and safety of investigational agent LEO 138559 in adults with moderate-to-severe atopic dermatitis met its primary endpoint.
  • Results were shared as one of two LEO Pharma late breaker oral presentations at the 2023 American Academy of Dermatology (AAD) Annual Meeting.1 LEO 138559 is an investigational agent and its efficacy and safety are subject to further larger trials.
  • LEO Pharma and argenx BV jointly developed LEO 138559 under an exclusive option and research agreement.
  • LEO Pharma obtained the license to LEO 138559 in 2022 and now assumes the responsibility to develop and commercialize LEO 138559 for inflammatory skin disorders, such as atopic dermatitis.

Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer

Retrieved on: 
Thursday, March 16, 2023

The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age.

Key Points: 
  • The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age.
  • These approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG.
  • BRAF V600 mutations are present in 15-20% of pediatric LGGs and are associated with poor survival outcomes and less favorable response to chemotherapy4.
  • BRAF mutations have been identified as drivers of cancer growth across a wide range of solid tumors, and often have limited treatment options4,5.

Esperion Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, February 21, 2023

ANN ARBOR, Mich., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

Key Points: 
  • “I’m proud of the entire organization at Esperion and our ability to deliver on the commitments we made in 2022.
  • The increase for the fourth quarter ended December 31, 2022, is related to increases in net U.S. product revenue and royalty revenue.
  • These decreases reflect savings from the transformative plan implemented in the fourth quarter of 2021.
  • Esperion works hard to make our medicines easy to get, easy to take, and easy to have.

Esperion Announces Positive CLEAR Outcomes Results To Be Presented as Late-Breaking Clinical Trial at ACC.23/WCC

Retrieved on: 
Monday, February 20, 2023

Hyperuricemia may occur early in treatment and persist throughout treatment, and may lead to the development of gout, especially in patients with a history of gout.

Key Points: 
  • Hyperuricemia may occur early in treatment and persist throughout treatment, and may lead to the development of gout, especially in patients with a history of gout.
  • Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
  • Drug Interactions: Simvastatin and Pravastatin: Concomitant use results in increased concentrations and increased risk of simvastatin or pravastatin-related myopathy.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

Incyte Announces 52-Week Results from Phase 2 Study Evaluating Povorcitinib (INCB54707) in Patients with Hidradenitis Suppurativa

Retrieved on: 
Friday, February 10, 2023

Incyte (Nasdaq:INCY) today announced new 52-week results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (formerly INCB54707), an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS).

Key Points: 
  • Incyte (Nasdaq:INCY) today announced new 52-week results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (formerly INCB54707), an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS).
  • These data were presented as an oral presentation (Abstract #258) at the 12th Conference of the European Hidradenitis Suppurativa Foundation, held from February 8-10, 2023, in Florence, Italy.
  • Povorcitinib was generally well tolerated and the safety profile was consistent with previously-reported data.
  • We look forward to continuing to progress the development of povorcitinib through our ongoing Phase 3 trial in patients with moderate-to-severe HS.”
    Additional 52-week efficacy results include:

Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2022 with Webcast and Conference Call Today at 4:30 p.m. ET

Retrieved on: 
Tuesday, February 7, 2023

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today reported financial results for its fiscal first quarter ended December 31, 2022.

Key Points: 
  • Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today reported financial results for its fiscal first quarter ended December 31, 2022.
  • For the three months ended December 31, 2021, total royalty revenue was $27.6 million on AbbVie’s sales of MAVYRET/MAVIRET.
  • The decline is primarily a result of continued lower treated patient volumes due to the COVID-19 pandemic.
  • Research and development expenses totaled $40.9 million for the three months ended December 31, 2022, compared to $48.5 million for the three months ended December 31, 2021.