Medical

Apeiron Respiratory Therapies (Arest), a subsidiary of Invios, announced that a Phase 1 SAD/MAD study of its APN01 nebulized alunacedase alfa in 40 healthy subjects met all endpoints. Both Arest and Invios were spun off from the original developer of APN01, Apeiron Biologics, earlier this year. Arest is developing APN01, a soluble recombinant human angiotensin … [Read more...] about Arest announces positive Phase 1 results for APN01 inhaled alunacedase alfa

Renovion and the COPD Foundation have announced the initiation of a Phase 2 trial of Renovion's ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid in patients with non-CF bronchiectasis (NCFBE). The COPD Foundation announced in September 2021 that it was partnering with Renovion on development of ARINA-1 for the treatment of COPD and NCFBE. The company is … [Read more...] about Renovion initiates Phase 2 trial of ARINA-1 inhaled mucolytic in non-CF bronchiectasis patients

Pieris Pharmaceuticals has announced the initiation of a Phase 1 study of PRS-220, an anticalin inhalation solution that targets connective tissue growth factor (CTGF), which the company is developing for the treatment of fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). In June 2021, Pieris announced that it would develop PRS-220 for IPF and for … [Read more...] about Pieris Pharmaceuticals initiates Phase 1 trial of its PRS-220 inhaled anticalin

Codagenix has announced the initiation of a Phase 3 trial of its CoviLiv live-attenuated intranasal vaccine against COVID-19. The trial, which is being conducted in partnership with the Serum Institute of India, is part of the World Health Organization's Solidarity Trial Vaccines trial. The Phase 3 study is expected to enroll up to 20,000 healthy adults in countries … [Read more...] about Phase 3 trial of Codagenix’s CoviLiv intranasal vaccine against COVID-19 gets underway

According to Covis Pharma, the Phase 3 AVANT trial of Duaklir aclidinium bromide / formoterol and Eklira (Tudorza) aclidinium bromide DPIs demonstrated statistically significant change in FEV1 from baseline one hour post dose for Duaklir vs Eklira alone and vs formoterol alone, as well as for Eklira vs placebo. Covis acquired global rights to Duaklir and Eklira from … [Read more...] about Covis announces positive results from Phase 3 trial of Duaklir and Eklira in Asia

Atai Life Sciences announced that it has initiated a Phase 1 proof-of-concept trial of its INB-01, an excipient designed to cause gelling of liquid nasal sprays when the aerosol deposits in the nasal cavity. In July 2021, Atai said that it was launching a company called Innaris Bio to develop the sol-gel technology for use in intranasal CNS drug formulations in … [Read more...] about Atai Life Sciences initiates Phase 1 trial of INB-01 intranasal gelling excipient

According to Milestone Pharmaceuticals, the Phase 3 RAPID (formerly NODE 301b) trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) has met its primary endpoint, demonstrating that almost two thirds of patients using etripamil converted to sinus rhythm within half an hour while less than a third of patients using a placebo … [Read more...] about Phase 3 trial of Milestone’s etripamil nasal spray for PSVT meets primary endpoint

According to Orexo, a Phase 1 trial of OX640 nasal epinephrine powder demonstrated that each of 4 formulations evaluated was safe and well tolerated and achieved epinephrine plasma levels comparable to autoinjected intramuscular epinephrine (EpiPen). Each of the intranasal formulations also produced concentration-dependent changes in blood pressure and heart rate. The … [Read more...] about Positive Phase 1 results for Orexo’s OX640 intranasal epinephrine