Cyrano Therapeutics has announced the initiation of the Phase 2 FLAVOR trial of CYR-064 theophylline soft-mist nasal spray in patients who have lost their sense of smell following a viral infection. Cyrano announced plans for the Phase 2 trial in January 2023. The FLAVOR trial will compare the safety and tolerability of two doses of CYR-064 to placebo over a 6-month … [Read more...] about Phase 2 trial of Cyrano’s intranasal theophylline for the treatment of post-viral hyposmia gets underway
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Akita Biosciences launches Profi antiviral nasal spray
Startup Akita Biosciences, newly launched by faculty members of Brigham & Women's Hospital to develop intranasal therapies, has announced the availability of its first nasal product. The company says that Profi prophylactic nasal spray is "a drug-free formulation composed predominantly of ingredients that have previously been used intranasally at doses higher than … [Read more...] about Akita Biosciences launches Profi antiviral nasal spray
NIAID will conduct study evaluating inhaled versus nasal delivery of Ocugen’s OCU500 vaccine against COVID-19
According to Ocugen, the US National Institute of Allergy and Infectious Diseases (NIAID) will conduct a study comparing the immune response generated by Ocugen's OCU500 vaccine candidate delivered via inhalation versus OCU500 delivered as a nasal spray. The research will be conducted as part of Project NextGen, which is expected to begin clinical trials early next … [Read more...] about NIAID will conduct study evaluating inhaled versus nasal delivery of Ocugen’s OCU500 vaccine against COVID-19
Oragenics to acquire Odyssey Health’s nasal delivery technology
Oragenics will acquire Odyssey Health's breath-powered intranasal delivery device and dry powder nasal formulations, in a deal that includes 8 million shares of Oragenics Series F preferred stock and a total of $1 million in cash, the companies said. The drugs included in the deal are Odyssey's OPN-002 for the treatment of mild traumatic brain injury and ONP-001 for … [Read more...] about Oragenics to acquire Odyssey Health’s nasal delivery technology
Previewing DDL 2023
The annual Drug Delivery to the Lungs meeting returns to the Edinburgh International Conference Centre (EICC) December 6-8. DDL 2022 attracted a total of more than 1,000 delegates in person and online, and DDL 2023 is also expected to draw a large crowd, says organizing committee member Michelle Dawson. For the first time, DDL will take over the entire EICC, providing … [Read more...] about Previewing DDL 2023
Gossamer Bio names Rainer Zimmermann as VP of Medical Affairs
Gossamer Bio, which is developing its seralutinib DPI for the treatment of pulmonary arterial hypertension (PAH), has announced the appointment of Rainer Zimmermann as VP of Medical Affairs. Zimmermann was most recently Global Medical Leader, Pulmonary Hypertension, at Janssen. Prior to Johnson & Johnson, Zimmermann served as Global Medical Lead, PH Franchise, at … [Read more...] about Gossamer Bio names Rainer Zimmermann as VP of Medical Affairs
Codagenix gets BARDA funding for Phase 2b trial of CoviLiv intranasal vaccine against COVID-19
According to Codagenix, the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) will provide up to $389 million to support a Phase 2b trial of CoviLiv live attenduated intranasal vaccine as a booster. Under the contract, the first tranche provided by BARDA will be $10 million. Codagenix is developing CoviLiv in … [Read more...] about Codagenix gets BARDA funding for Phase 2b trial of CoviLiv intranasal vaccine against COVID-19
Pneumagen says Phase 2 challenge study of Neumifil antiviral nasal spray against influenza met primary and secondary endpoints
Pneumagen announced that a Phase 2 challenge study Neumifil multivalent carbohydrate binding module (mCBM) nasal spray against influenza met its primary endpoints, demonstrating statistically significant reductions in the rate of infection and in symptom severity compared to placebo. The initiation of the challenge study was announced in August 2022. The company … [Read more...] about Pneumagen says Phase 2 challenge study of Neumifil antiviral nasal spray against influenza met primary and secondary endpoints
FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA
GH Research announced that the FDA has placed a clinical hold on an IND that the company submitted for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression, citing "Insufficient information to assess risks to human subjects." The company said that it is waiting to learn more details from the FDA about the reasons for the clinical … [Read more...] about FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA
Avalyn Pharma raises $175 million for continued development of AP01 inhaled pirfenidone and AP02 inhaled nintedanib
Avalyn Pharma announced that an oversubscribed Series C financing brought in $175 million that the company will use for continued development of AP01 inhaled pirfenidone and AP02 inhaled nintedanib for the treatment of pulmonary fibrosis. Earlier this year, the company reported data from a Phase 1b trial of nebulized AP01 in patients with idiopathic pulmonary fibrosis … [Read more...] about Avalyn Pharma raises $175 million for continued development of AP01 inhaled pirfenidone and AP02 inhaled nintedanib