Clarus Therapeutics, Inc.

None  Welcome to this week's (and last week's) Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Bayer backs Anderson for CEO role, Bauman slated to depart Bayer Bayer AG made a seismic hire this week, naming former Roche pharmaceutical chief Bill Anderson as the company’s new CEO. The news comes just two months after Anderson announced his departure from the company. As a result, current Bayer chief Werner Baumann will depart his post early, pacifying investors who felt he hasn’t been up to snuff. The move caps off a 35-year career for Baumann at Bayer.  The addition of Anderson marks a concerted refocusing on the company’s pharmaceutical and drug development pursuits, attempting to leave behind a reputation marred by the acquisition of Monsanto. Bayer noted in its announcement that Anderson was involved in the launch of 25 new medicines.  The move also reignites debate over whether the company’s consumer health and agricultural businesses should stay linked under one life sciences umbrella. Activist investors have advocated that the two be split up. Any reconsideration of the matter is still months away at least, with Anderson not slated to officially take the reins until June. Fierce Pharma Astellas implements new leadership strategy, tapping CSO Okamura for chief exec role Astellas Pharma Astellas Pharma has found its next leader within its internal constellation of executives, naming Chief Strategy Officer Naoki Okamura as the company’s new CEO. His promotion to the top role comes after 37 years at the company. Simultaneously, current CEO Kenji Yasukawa is moving into the chairman role, closing out five years as CEO. Replacing Okamura as strategy chief will be VP of corporate strategy Adam Pearson.  Okamura helped orchestrate a number of critical business development moves, including acquiring Audentes for $3 billion in 2019 and CAR-T company Xyphos for $665 million. The company also inked a couple of new partnerships last month, including an antibody research collaboration with Twist Biosciences.  Under Yasukawa’s leadership, Astellas moved away from focusing on specific disease areas and instead took a more multifaceted approach. And it appears to be paying off, as the company announced a 17% increase in revenue over the last nine months compared to the nine-month period a year earlier. Fierce Pharma Nelson wraps up eight month stint as head of White House science and tech wing White House Alondra Nelson is departing the White House Office of Science and Technology Policy at the end of the week, wrapping up two years at the office, eight months of which were as leader. She was appointed to lead the office after Eric Lander was ousted following allegations of bullying and fostering a toxic work environment.  Prior to filling the leadership vacuum left by Lander, Nelson ran the Science and Society team within the larger OSTP branch. The Science and Society unit was created under the Biden administration.  Much of Nelson’s work centered around designing ethical policy around artificial intelligence and improving transparency in federally-funded research. She spearheaded the creation of the Blueprint for an AI Bill of Rights, an in-depth framework regarding the use of AI in society and its implications.  She’ll be returning to the Institute for Advanced Study in Princeton, New Jersey, where she was a social science professor before joining the Biden administration. Tweet > Johnson & Johnson is overhauling operations for its Janssen pharmaceutical unit, with sweeping layoffs expected to claim staffers' jobs across the globe. Part of the so-called “comprehensive review” of its portfolio includes plans to operate its vaccines and infectious diseases outfits as one group. Consequently, James Merson, Ph.D., current head of the infectious disease unit, is set to leave the company “to pursue his next opportunity” while Penny Heaton, M.D., head of the existing vaccines division, will oversee the merged unit. Fierce Pharma > Iya Khalil, Ph.D., will be jumping from Novartis to Merck & Co., starting in her new role as VP and head of data, AI and genome sciences on Feb. 13. At Novartis, Khalil worked as global head of the AI Innovation Laboratory and has more than 20 years of experience pioneering AI/ML work, according to an emailed statement a Merck spokesperson sent Fierce Biotech.   > Three months after Rubius Therapeutics slashed most of its staff, Chief Scientific Officer Laurence Turka, M.D., stepped down. Turka—who also served as head of research and translational medicine—was joined by three board members, who also resigned. In November, CEO and President Dannielle Appelhans was set to leave in January, though Appelhans has now agreed to stay on until March 3. After former CEO Pablo Cagnoni and former Chief Financial Officer Pepe Carmona exited in November, Appelhans is set to be the only C-suite executive left. Release    > As Magenta Therapeutics winds down, a long list of C-suite executives have hit the exits. That includes CEO Jason Gardner, Chief Technical Officer David Nichols, Chief Commercial Officer Caren Deardorf, Chief People Officer Kristen Stants and Senior Vice President and Head of Clinical Development Shawn Rose. Gardner, Nichols and Deardorf will stay somewhat involved in as-needed consulting roles. The stem cell transplant biotech has also cut 56 positions, or 84% of staff, in an effort to save money. Fierce Biotech   > Ovid Tx has tapped Eisai’s Manoj Malhotra, M.D., as its chief medical officer and Takeda’s Toshiya Nishi to serve as head of epilepsy research. During his time at Takeda, Malhotra led global medical affairs for its epilepsy and multiple sclerosis units. Malhotra has held roles at Mallinckrodt Pharmaceuticals, Takeda Pharmaceutical and within Novartis Medical Affairs. Nishi also most recently worked at a Big Pharma, serving as a scientist in neuroscience drug discovery and translational medicine for Takeda. He also worked for Ovid as a visiting research fellow for two years starting in 2017. Release   > Former Viridian Therapeutics CEO and President Jonathan Violin, Ph.D., has stepped down, though he will serve as a company consultant for one year. In his place steps Scott Myers, who most recently served as AMAG Pharmaceuticals’ president and CEO from April 2020 until its acquisition by Covis Group in October 2020. Myers has plenty of CEO experience, previously holding the top title across several biotechs, including Rainier Therapeutics (formerly BioClin Therapeutics), Cascadian Therapeutics (acquired by Seattle Genetics) and Aerocrine (acquired by Circassia Pharmaceuticals). Release   > Adam Crystal, M.D., Ph.D., will leave his role as chief medical officer at C4 Therapeutics on Feb. 24, to pursue an opportunity as a head of R&D. Crystal has been C4’s CMO since 2019 and, before that, worked at Novartis Institutes for Biomedical Research. Upon his departure, Solid Therapeutics co-founder and biotech consultant Hagop Youssoufian, M.D., will serve as interim CMO. Release  > After a 70% workforce reduction in January and reprioritizing its pipeline, Cyteir is eliminating the roles of chief business officer and chief scientific officer. CBO Andrew Gengos departed Feb. 3, while CSO Paul Secrist, Ph.D., plans to leave April 1. Release > Blue Water Vaccines is bringing on Frank Jaeger to serve as  SVP of marketing and business development. Jaeger joins from Clarus Therapeutics, where he was SVP and chief commercial officer, and helped take the company public last spring. Release   > 2seventy bio Chief Operating Officer Nicola Heffron will be leaving the biotech next month, effective March 10. Release   > General manager of Novo Nordisk’s U.K. operations Pinder Sahota has decided to resign from his role as president of the Association of the British Pharmaceutical Industry (ABPI). The decision was made in efforts to avoid distracting from ABPI’s work amid an ongoing Novo Nordisk ABPI Code of Practice case. ABPI Vice President Susan Rienow, president of Pfizer UK, will temporarily take on the president’s roles and responsibilities until a new leader is chosen. Release   > Clinical-stage Adiso Therapeutics has appointed Srikar Guntaka, M.D., to the company’s newly created role of medical director. Most recently, Guntaka served as medical director and clinical development lead at Mirum Pharmaceuticals. He also has worked in positions at AbbVie and Baxter Healthcare. Release  > Harlan Weisman, M.D., has been selected to helm TFF Pharmaceuticals as permanent CEO. The former interim CEO has served as the company’s vice chair since 2018. In the past, he served as Flame Biosciences’ co-founder, CEO, president and chair, and was also former co-founder and chief scientific officer for Mycrobiomics. Earlier in his career, Weisman worked with J&J. Release   > Orchestra BioMed is conducting several organizational changes, tapping several new additions for its senior leadership team. Avi Fischer, M.D., joins from ElectroPhysiology Frontiers, where he was CEO, to serve as Orchestra's SVP of medical affairs and innovation, while J.C. Simeon joins from Amring Pharmaceuticals to take on the role of SVP of quality. Meanwhile, former SVP of Quality George Papandreou, Ph.D., will become Orchestra’s general manager and SVP of focal therapies. Lastly, previous Senior Director of Formulation Development Kunal Faldu has been promoted to serve as VP of pharmaceutical development. Release   > T-knife Therapeutics has cut to the chase, appointing Behzad Kharabi, M.D., to serve as chief medical officer for the immunotherapy company. Kharabi joins from Gilead’s Kite, where he led global clinical development for TECARTUS, an approved cell-based gene therapy for treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Before Kite, Kharabi worked for J&J’s Janssen Pharmaceuticals. Release  > Palisade Bio has promoted Robert McRae, who joined the company in 2021, as SVP of operations and strategic development, to chief operating officer. Before Palisade, McRae held several leadership positions at Viracta Therapeutics. Release

LONDON, UK I January 11, 2023 I Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces that the US Food and Drug Administration (FDA) has approved AstraZeneca's Airsupra (albuterol/budesonide, formerly known as PT027) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS). The US approval was based on positive results from a global Phase III clinical trial programme for Airsupra comprising four studies involving more than 4,000 patients (including the MANDALA and DENALI trials 1,2 ), which was conducted successfully by Avillion under an exclusive clinical co-development agreement with AstraZeneca. Under its 2018 agreement, Avillion had regulatory responsibility including filing the New Drug Application (NDA) through to FDA approval in the US. Following this approval, AstraZeneca has the option, upon making certain financial payments to Avillion, to commercialise Airsupra in the US. This milestone continues Avillion's 100% successful rate in clinical co-development partnerships for the global pharmaceutical and biotech industry. In MANDALA, Airsupra significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms. 1 The results from the MANDALA trial were published in the New England Journal of Medicine in May 2022. 1 In DENALI, Airsupra significantly improved lung function compared to the individual components, albuterol and budesonide, in patients with mild to moderate asthma. 2 The safety and tolerability of Airsupra in both trials were consistent with the known profiles of the components, 1,2 with the most common adverse events including headache, oral candidiasis, cough and dysphonia. 3 The co-development partnership between AstraZeneca and Avillion has recently expanded to include the BATURA study, a randomised Phase IIIb decentralised trial to further assess the role of Airsupra in reducing the risk of asthma exacerbations. The Airsupra clinical co-development programme was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth. Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said: "People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. The approval of Airsupra means that, for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease." Allison Jeynes, MD, Chief Executive Officer of Avillion, said: "We're delighted that our clinical co-development programme with AstraZeneca has been successful and that Airsupra has been approved in the US as a new treatment option for asthma patients. The Airsupra approval continues our 100% success rate facilitating clinical co-development programmes with pharma companies, demonstrating the strong value our innovative model can provide to partners and the excellence and dedication of our international team. We've had an excellent working relationship with AstraZeneca and are excited to continue our partnership with the BATURA Phase IIIb study, which is looking to continue building the evidence base of Airsupra to reduce the risk of asthma exacerbations." The full press announcement from AstraZeneca on the US approval of Airsupra can be found here . Notes Asthma Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide, 4 including over 25 million in the US. 5 Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency. 6 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control. 7,8 There are an estimated 136 million asthma exacerbations globally per year, 9 including 10 million in the US; 5 these are physically threatening and emotionally significant for many patients 11 and can be fatal. 4,11 Inflammation is central to both asthma symptoms 7 and exacerbations. 12 Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine; 13-15 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations, 16 which can result in impaired quality of life, 17 hospitalisation 18 and frequent oral corticosteroid (OCS) use. 18 Treatment of exacerbations with as few as 1-2 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture. 19 International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy. 6 MANDALA, DENALI and the CREST (Combination REliever STudies) programme The CREST clinical trial programme studied the efficacy and safety of PT027 and included the MANDALA, 1,20,21 DENALI 2,22,23 and TYREE 25 Phase III trials. MANDALA 1,20,21 was a Phase III, randomised, double-blind, multicentre, parallel-group, event-driven trial evaluating the efficacy and safety of Airsupra compared to albuterol on the time to first severe asthma exacerbation in 3,132 adults, adolescents, and children (aged 4–11 years) with moderate to severe asthma taking ICS alone or in combination with a range of asthma maintenance therapies, including long-acting beta2-agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA) or theophylline. The trial comprised a two-to-four-week screening period, at least a 24-week treatment period and a two-week post-treatment follow-up period. Patients were randomly assigned to one of the following three treatment groups in a 1:1:1 ratio: Airsupra 180/160mcg (excluding children aged 4–11 years), albuterol/budesonide 180/80mcg or albuterol 180mcg, taken as an as-needed rescue medicine. Airsupra and the albuterol comparator were delivered in a pMDI using AstraZeneca's Aerosphere delivery technology. The primary efficacy endpoint was the time to first severe asthma exacerbation during the treatment period. Secondary endpoints included severe exacerbation rate (annualised), total systemic corticosteroid exposure (annualised), asthma control and health-related quality of life. Results from the positive MANDALA Phase III trial showed that Airsupra demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma 1,21 . Compared with albuterol rescue, Airsupra at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% (p<0.001) in adults and adolescents 1,21 . Primary and secondary endpoint results in adults and adolescents 1,21 (pre-planned on-treatment efficacy analysis) a Deterioration of asthma requiring use of SCS for ≥3 days, or inpatient hospitalisation, or emergency room visit, that required SCS. b Before discontinuation of randomised treatment or change in maintenance therapy. CI, confidence interval; SCS, systemic corticosteroid; SD, standard deviation Primary endpoint results in adults, adolescents, and children 1,21 (pre-planned on-treatment efficacy analysis) a Deterioration of asthma requiring use of SCS for ≥3 days, or inpatient hospitalisation, or emergency room visit, that required SCS. b Before discontinuation of randomised treatment or change in maintenance therapy. CI, confidence interval Adverse events (AEs) were similar across the treatment groups in the trial and consistent with the known safety profiles of the individual components, with the most common AEs including nasopharyngitis and headache. 1,22 DENALI 2,23,24 was a Phase III, randomised, double-blind, placebo-controlled, multicentre, parallel-group trial evaluating the efficacy and safety of Airsupra compared to its components albuterol and budesonide on improvement in lung function in 1,001 adults, adolescents, and children aged 4–11 years with mild to moderate asthma previously treated either with SABA as-needed alone or in addition to regular low-dose ICS maintenance therapy. The trial comprised a two-to-four-week screening period, a 12-week treatment period and a two-week post-treatment follow-up period. Patients were randomly assigned to one of the following five treatment groups in a 1:1:1:1:1 ratio: Airsupra 180/160mcg four times daily (excluding children aged 4–11 years), albuterol/budesonide 180/80mcg four times daily, albuterol 180mcg four times daily, budesonide 160mcg four times daily (excluding children aged 4–11 years) and placebo four times daily. Airsupra , the albuterol and budesonide comparators and placebo were delivered in a pMDI using AstraZeneca's Aerosphere delivery technology. The dual primary efficacy endpoints were change from baseline in FEV1 area under the curve 0-6 hours over 12 weeks of Airsupra compared to budesonide to assess the effect of albuterol and change from baseline in trough FEV1 at Week 12 of Airsupra compared to albuterol to assess the effect of budesonide. Secondary endpoints included the time to onset and duration of response on day one, number of patients who achieved a clinically meaningful improvement in asthma control from baseline at Week 12 and trough FEV1 at Week 1. In the trial, Airsupra demonstrated a statistically significant improvement in lung function measured by forced expiratory volume in one second (FEV1), compared to the individual components albuterol and budesonide, and compared to placebo in patients with mild to moderate asthma aged 12 years or older. Onset of action and duration of effect were similar for Airsupra and albuterol. The safety and tolerability of Airsupra in DENALI was consistent with the known profiles of the components. About Avillion Avillion offers pharma partners an innovative model providing additional funding and clinical development expertise, to maximise the potential of new and existing assets. With deal sizes ranging from $50M–$600M, Avillion takes on the full clinical and regulatory risk, focusing on the speed and quality of trial execution. Typically supporting programs post proof-of-concept through to registration and with an agnostic approach to therapy area, Avillion prides itself in adding value around operational expertise while being backed by established long-term investors. Avillion was founded in 2012 and is backed by Abingworth and Blackstone Life Sciences (previously Clarus Ventures). The Airsupra clinical co-development programme was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth. For more information, please visit us at www.avillionllp.com References SOURCE: Avillion

Airsupra is the first and only rescue medication approved in the US for as-needed use to reduce risk of asthma exacerbations Approval based on successful Phase III trial programme conducted by Avillion in more than 4,000 patients under an exclusive clinical co-development agreement with AstraZeneca Continues Avillion's 100% success rate in clinical co-development partnerships across multiple therapeutic areas LONDON, Jan. 11, 2023 /PRNewswire/ -- Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces that the US Food and Drug Administration (FDA) has approved AstraZeneca's Airsupra (albuterol/budesonide, formerly known as PT027) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS). The US approval was based on positive results from a global Phase III clinical trial programme for Airsupra comprising four studies involving more than 4,000 patients (including the MANDALA and DENALI trials1,2), which was conducted successfully by Avillion under an exclusive clinical co-development agreement with AstraZeneca. Under its 2018 agreement, Avillion had regulatory responsibility including filing the New Drug Application (NDA) through to FDA approval in the US. Following this approval, AstraZeneca has the option, upon making certain financial payments to Avillion, to commercialise Airsupra in the US. This milestone continues Avillion's 100% successful rate in clinical co-development partnerships for the global pharmaceutical and biotech industry. In MANDALA, Airsupra significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms.1 The results from the MANDALA trial were published in the New England Journal of Medicine in May 2022.1 In DENALI, Airsupra significantly improved lung function compared to the individual components, albuterol and budesonide, in patients with mild to moderate asthma.2 The safety and tolerability of Airsupra in both trials were consistent with the known profiles of the components,1,2 with the most common adverse events including headache, oral candidiasis, cough and dysphonia.3 The co-development partnership between AstraZeneca and Avillion has recently expanded to include the BATURA study, a randomised Phase IIIb decentralised trial to further assess the role of Airsupra in reducing the risk of asthma exacerbations. The Airsupra clinical co-development programme was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth. Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said: "People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. The approval of Airsupra means that, for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease." Allison Jeynes, MD, Chief Executive Officer of Avillion, said: "We're delighted that our clinical co-development programme with AstraZeneca has been successful and that Airsupra has been approved in the US as a new treatment option for asthma patients. The Airsupra approval continues our 100% success rate facilitating clinical co-development programmes with pharma companies, demonstrating the strong value our innovative model can provide to partners and the excellence and dedication of our international team. We've had an excellent working relationship with AstraZeneca and are excited to continue our partnership with the BATURA Phase IIIb study, which is looking to continue building the evidence base of Airsupra to reduce the risk of asthma exacerbations." The full press announcement from AstraZeneca on the US approval of Airsupra can be found here. Notes Asthma Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,4 including over 25 million in the US.5 Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.6 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.7,8 There are an estimated 136 million asthma exacerbations globally per year,9 including 10 million in the US;5 these are physically threatening and emotionally significant for many patients11 and can be fatal.4,11 Inflammation is central to both asthma symptoms7 and exacerbations.12 Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine;13-15 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,16 which can result in impaired quality of life,17 hospitalisation18 and frequent oral corticosteroid (OCS) use.18 Treatment of exacerbations with as few as 1-2 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.19 International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.6 MANDALA, DENALI and the CREST (Combination REliever STudies) programme The CREST clinical trial programme studied the efficacy and safety of PT027 and included the MANDALA,1,20,21 DENALI2,22,23 and TYREE25 Phase III trials. MANDALA1,20,21 was a Phase III, randomised, double-blind, multicentre, parallel-group, event-driven trial evaluating the efficacy and safety of Airsupra compared to albuterol on the time to first severe asthma exacerbation in 3,132 adults, adolescents, and children (aged 4–11 years) with moderate to severe asthma taking ICS alone or in combination with a range of asthma maintenance therapies, including long-acting beta2-agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA) or theophylline. The trial comprised a two-to-four-week screening period, at least a 24-week treatment period and a two-week post-treatment follow-up period. Patients were randomly assigned to one of the following three treatment groups in a 1:1:1 ratio: Airsupra 180/160mcg (excluding children aged 4–11 years), albuterol/budesonide 180/80mcg or albuterol 180mcg, taken as an as-needed rescue medicine. Airsupra and the albuterol comparator were delivered in a pMDI using AstraZeneca's Aerosphere delivery technology. The primary efficacy endpoint was the time to first severe asthma exacerbation during the treatment period. Secondary endpoints included severe exacerbation rate (annualised), total systemic corticosteroid exposure (annualised), asthma control and health-related quality of life. Results from the positive MANDALA Phase III trial showed that Airsupra demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma1,21. Compared with albuterol rescue, Airsupra at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% (p<0.001) in adults and adolescents1,21. Primary and secondary endpoint results in adults and adolescents1,21 (pre-planned on-treatment efficacy analysis) aDeterioration of asthma requiring use of SCS for ≥3 days, or inpatient hospitalisation, or emergency room visit, that required SCS. bBefore discontinuation of randomised treatment or change in maintenance therapy. CI, confidence interval; SCS, systemic corticosteroid; SD, standard deviation Primary endpoint results in adults, adolescents, and children1,21 (pre-planned on-treatment efficacy analysis) aDeterioration of asthma requiring use of SCS for ≥3 days, or inpatient hospitalisation, or emergency room visit, that required SCS. bBefore discontinuation of randomised treatment or change in maintenance therapy. CI, confidence interval Adverse events (AEs) were similar across the treatment groups in the trial and consistent with the known safety profiles of the individual components, with the most common AEs including nasopharyngitis and headache.1,22 DENALI2,23,24 was a Phase III, randomised, double-blind, placebo-controlled, multicentre, parallel-group trial evaluating the efficacy and safety of Airsupra compared to its components albuterol and budesonide on improvement in lung function in 1,001 adults, adolescents, and children aged 4–11 years with mild to moderate asthma previously treated either with SABA as-needed alone or in addition to regular low-dose ICS maintenance therapy. The trial comprised a two-to-four-week screening period, a 12-week treatment period and a two-week post-treatment follow-up period. Patients were randomly assigned to one of the following five treatment groups in a 1:1:1:1:1 ratio: Airsupra 180/160mcg four times daily (excluding children aged 4–11 years), albuterol/budesonide 180/80mcg four times daily, albuterol 180mcg four times daily, budesonide 160mcg four times daily (excluding children aged 4–11 years) and placebo four times daily. Airsupra, the albuterol and budesonide comparators and placebo were delivered in a pMDI using AstraZeneca's Aerosphere delivery technology. The dual primary efficacy endpoints were change from baseline in FEV1 area under the curve 0-6 hours over 12 weeks of Airsupra compared to budesonide to assess the effect of albuterol and change from baseline in trough FEV1 at Week 12 of Airsupra compared to albuterol to assess the effect of budesonide. Secondary endpoints included the time to onset and duration of response on day one, number of patients who achieved a clinically meaningful improvement in asthma control from baseline at Week 12 and trough FEV1 at Week 1. In the trial, Airsupra demonstrated a statistically significant improvement in lung function measured by forced expiratory volume in one second (FEV1), compared to the individual components albuterol and budesonide, and compared to placebo in patients with mild to moderate asthma aged 12 years or older. Onset of action and duration of effect were similar for Airsupra and albuterol. The safety and tolerability of Airsupra in DENALI was consistent with the known profiles of the components. About Avillion Avillion offers pharma partners an innovative model providing additional funding and clinical development expertise, to maximise the potential of new and existing assets. With deal sizes ranging from $50M–$600M, Avillion takes on the full clinical and regulatory risk, focusing on the speed and quality of trial execution. Typically supporting programs post proof-of-concept through to registration and with an agnostic approach to therapy area, Avillion prides itself in adding value around operational expertise while being backed by established long-term investors. Avillion was founded in 2012 and is backed by Abingworth and Blackstone Life Sciences (previously Clarus Ventures). The Airsupra clinical co-development programme was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth. For more information, please visit us at References Papi A, et al. Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med 2022; 386 (22): 2071-2083. Chipps BE, et al. Efficacy and safety of albuterol/budesonide (PT027) in mild-to-moderate asthma: Results of the DENALI study. Am J Respir Crit Care Med 2022; 205: A3414. Abstract. 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