AeroVanc (vancomycin hydrochloride inhalation powder) / Savara - LARVOL DELTA

A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients (clinicaltrials.gov) - P3; N=188; Completed; Sponsor: Savara Inc.; Active, not recruiting ➔ Completed; Trial completion date: Sep 2020 ➔ Jan 2021; Trial primary completion date: Mar 2020 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Respiratory Diseases

Savara Provides Pipeline and Business Update (Businesswire) - P3, N=200; NCT03181932; Sponsor: Savara Inc.; "The Company announced that the Phase 3 trial of AeroVanc (vancomycin hydrochloride inhalation powder) in people living with cystic fibrosis (CF) who have Methicillin-resistant Staphylococcus aureus (MRSA) lung infection did not meet the primary endpoint...Data from the trial showed a mean change from baseline in FEV1 percent predicted compared to placebo of 1.4 at week 4 (p=0.33), 1.3 at week 12 (p=0.33), and 3.0 at week 20 (p=0.07) in the primary analysis population of patients 6-21 years of age...Unfortunately, based on the AVAIL results, we are discontinuing further development of AeroVanc...the Company has discontinued the Apulmiq clinical development program...The Company today revised guidance on the initiation of IMPALA 2 and now expects the trial to start in Q2 2021, versus the end of Q1 2021."

Discontinued • P3 data • Trial initiation date • Cystic Fibrosis • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis

Fulminant C diff Debate: Fecal Transplants or Antibiotics? (Medscape) - "The discussion pitted fecal microbiota transplants (FMT) from the stool of healthy donors against traditional antibiotics....Though FMT is not approved by the US Food and Drug Administration (FDA) for fulminant CDI, Allegretti said, the FDA does allow treatment under 'enforcement discretion,' which means no investigational new drug license is needed specifically if treating CDI patients who haven't responded to standard therapy, as long as proper consent has been obtained."

Media quote • Regulatory

A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients (clinicaltrials.gov) - P3; N=200; Active, not recruiting; Sponsor: Savara Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed

Savara provides business update in response to COVID-19 pandemic (Businesswire) - “Savara Inc….today provided an update on the impact COVID-19 has had on two of the Company’s clinical studies in cystic fibrosis (CF). Due to the COVID-19 pandemic, and out of an abundance of caution for people living with CF and clinical study staff, enrollment has been terminated in the Phase 3 AVAIL and the Phase 2a ENCORE studies....The Company announced it would continue enrollment of the primary analysis population until Q2 2020. In light of the current pandemic, the Company stopped enrollment earlier than anticipated. Topline results are still expected in early 2021.”

Enrollment status • P3 data: top line