AT-301 / Atossa Therap - LARVOL DELTA

Atossa Therapeutics Announces First Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - P1, N=32; NCT04519788; Sponsor: Atossa Genetics, Inc.; "Announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19....R&D expenses for the three months ended March 31, 2021, were $1,379,000...We expect our R&D expenses to continue to increase into 2021 as we seek to commence a study of AT-H201, complete studies of AT-301..."

Commercial • P1 data • Infectious Disease • Novel Coronavirus Disease

Atossa Therapeutics President and CEO Dr. Steven C. Quay Issues Annual Letter to Stockholders Highlighting Key Accomplishments and Strategy for 2021 (GlobeNewswire) - "AT-301 Nasal Spray for the Treatment of COVID-19: During 2020, we completed successful in-vitro testing followed by a Phase 1 clinical study...We expect to release final data from this study in the first quarter of 2021 and then quickly start additional pre-clinical and clinical studies...AT-H201 Inhalation Therapy for COVID-19...We have applied to the regulatory authorities to conduct the initial clinical study of AT-H201 in Australia, which we anticipate receiving in first quarter 2021."

New trial • P1 data • Infectious Disease • Novel Coronavirus Disease

AT-301 Nasal Spray in Healthy Adults (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Atossa Genetics, Inc.; Recruiting ➔ Completed; N=50 ➔ 32

Clinical • Enrollment change • Trial completion

Noninvasive intratumoral thermal dose determination during in vivo magnetic nanoparticle hyperthermia: combining surface temperature measurements and computer simulations. (PubMed, Int J Hyperthermia) - "A new methodology for determining noninvasively the three-dimensional intratumoral thermal dose during MNH was developed. The method demonstrates the potential for predicting the long-term preclinical outcome of animals treated with MNH."

Journal • Preclinical • Oncology

Atossa Therapeutics Completes Enrollment of Phase 1 Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID (GlobeNewswire) - "Atossa Therapeutics, Inc....today announced it has now completed enrollment in its Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301....Atossa plans to identify potential partners...so that AT-301 nasal spray may be co-developed and commercialized....Next steps with this program include contracting for a commercial supply of the nasal spray devices; reporting preliminary top line results from the Phase 1 study; and completing regulatory filings and any necessary approvals to launch a Phase 2 study, which we are planning for the first half of 2021."

Commercial • Enrollment closed • P1 data • Novel Coronavirus Disease

Atossa Therapeutics Receives Second Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID (GlobeNewswire) - "Atossa Therapeutics, Inc....today announced a positive interim safety assessment from the second cohort of healthy participants in the Phase 1 clinical study....This second group of eight participants received a single escalated dose of either AT-301A (placebo) or AT-301B (active drug). The blinded, positive assessment by the safety committee allows the study to now enroll the next cohort, which will be the third of a total of four cohorts and the first of two multi-dose, placebo controlled cohorts."

DSMB • Infectious Disease • Novel Coronavirus Disease

Atossa Therapeutics Contracts for Clinical Study of AT-301 Nasal Spray, Atossa’s Second COVID-19 Therapeutic Development Program (GlobeNewswire) - "Atossa Therapeutics, Inc....announced that it has contracted with Avance Clinical Pty Ltd to conduct a clinical study of Atossa’s proprietary drug candidate AT-301, to be administered by nasal spray....The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups....An application to commence the study has been submitted to the relevant institutional review board (IRB) and local regulatory authority in Australia which must be approved before commencement of the study. Pending these approvals, Atossa expects that the study will commence this quarter."

Licensing / partnership • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

AT-301 Nasal Spray in Healthy Adults (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Atossa Genetics, Inc.

Clinical • New P1 trial

"For Laurel inpatient admissions, please call us at 301-490-5551. Outpatient enrollment can be reached at 301-490-5551 x122. Our treatment centers accept @Aetna, @CareFirst, @Cigna, Johns Hopkins EHP, @UHC and @USFHP. We also accept MD Medicaid, self-pay & other county funding." (@HopeHouseTC)

Clinical • Medicaid • Reimbursement

Atossa Therapeutics Announces Successful In Vitro Testing of Nasal Spray Formulation: AT-301 Inhibits SARS-CoV-2 Infectivity of VERO Cells in Laboratory Culture (GlobeNewswire) - "AT-301 is being developed with a nasal spray delivery mechanism....'We look forward to commencing a Phase 1 clinical study this quarter and reporting progress on this clinical development program.'"

New P1 trial • Infectious Disease • Novel Coronavirus Disease

Incidence, characteristics, outcomes and confidence in managing posterior capsular rupture during cataract surgery in the UK: an ophthalmology trainees' perspective. (PubMed, Eye (Lond)) - "We observed a low PCR rate among the trainees in our region, with the majority of cases achieving good visual outcome. A significant reduction in PCR rate was observed at the threshold of >500 cases. There is however a lack of confidence among trainees in managing PCR, highlighting the need for devising new training strategies in this area."

Journal • Cataract • Ophthalmology

Atossa Therapeutics Announces Second COVID-19 Therapeutic Development Program, AT-301 Nasal Spray: Summit Biosciences Retained to Develop and Supply AT-301 Nasal Spray for Clinical Study (GlobeNewswire, Atossa Therapeutics, Inc.) - "Atossa Therapeutics, Inc....announced that it has begun the development of a second COVID-19 program using its proprietary drug candidate AT-301, to be administered by nasal spray....Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2....Atossa has retained Summit Biosciences, Inc....to develop and produce a clinical supply of pre-filled nasal spray products in multi-dose devices containing AT-301 with the goal of commencing initial human clinical trials in the third quarter 2020."

New trial • Infectious Disease • Novel Coronavirus Disease