TFF Pharmaceuticals said that a Phase 1 SAD/MAD study of its tacrolimus inhalation powder, which the company is developing for the prevention of lung transplant rejection, demonstrated that the dry powder formulation can be dosed to achieve lung and blood concentrations of tacrolimus necessary for efficacy without causing kidney toxicity. Based on the Phase 1 results, … [Read more...] about Positive Phase 1 results for TFF’s inhaled tacrolimus
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Codagenix says it plans to advance COVI-VAC nasal vaccine to Phase 2/3 based on positive Phase 1 topline results
According to Codagenix, a Phase 1 dose escalation trial of its COVI-VAC intranasal vaccine against COVID-19 in healthy adults has demonstrated "promising safety and immunogenicity results." Codagenix and Serum Institute of India initiated the Phase 1 trial in December 2020. Based on the Phase 1 data, the company said that it plans to advance COVI-VAC into Phase 2/3 … [Read more...] about Codagenix says it plans to advance COVI-VAC nasal vaccine to Phase 2/3 based on positive Phase 1 topline results
Positive Phase 2 results for Pulmotect’s PUL-042 inhaled immunostimulant against COVID-19
Pulmotect has announced topline results from one of two Phase 2 trials of its PUL-042 immunostimulant inhalation solution demonstrating that PUL-042 therapy significantly reduced the time to respiratory symptom improvement in early-stage COVID-19 patients. The company announced its plans to initiate the two trials in May 2020 and later announced that the US Department … [Read more...] about Positive Phase 2 results for Pulmotect’s PUL-042 inhaled immunostimulant against COVID-19
COPD Foundation partners with Renovion for development of inhaled mucolytic
The COPD Foundation has partnered with Renovion on development of Renovion's ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the treatment of COPD and non-cystic fibrosis bronchiectasis, the foundation said. ARINA-1, which is delivered via the PARI eFlow nebulizer system, received orphan drug designation from the FDA for the treatment of lung … [Read more...] about COPD Foundation partners with Renovion for development of inhaled mucolytic
Phase 2 trial of inhaled Ampion for COVID-19 gets approval from Indian authorities
According to Ampio Pharmaceuticals, the Drugs Controller General of India (DCGI) has approved the protocol for AP-019 Phase 2 trial of the company's inhaled Ampion biologic for the treatment of respiratory distress caused by COVID-19. Ampio announced in June 2021 that it had initiated the Phase 2 AP-019 clinical trial in the US and noted that the FDA had approved … [Read more...] about Phase 2 trial of inhaled Ampion for COVID-19 gets approval from Indian authorities
GSK says it is evaluating new MDI propellant as part of commitment to reducing greenhouse gas emissions
GlaxoSmithKline has announced an initiative to evaluate a new lower global warming potential propellant for its metered dose inhalers as part of an effort to reach net zero carbon emissions. According to GSK, its Ventolin albuterol (salbutamol) MDIs for the rescue treatment of asthma account for 45% of the company's current carbon emissions, and the company expects … [Read more...] about GSK says it is evaluating new MDI propellant as part of commitment to reducing greenhouse gas emissions
Virpax to develop intranasal CBD for the treatment of epilepsy
Virpax says that it has acquired exclusive worldwide rights to Nanomerics's molecular envelope technology (MET) for use with Virpax's VRP324 intranasal dry powder cannabidiol (CBD) for the treatment of epilepsy. According to Virpax, Nanomerics is currently conducting preclinical studies of VRP324, which Virpax plans to develop for the treatment of seizures due to … [Read more...] about Virpax to develop intranasal CBD for the treatment of epilepsy
Neurelis initiates Phase 1/2a study of Valtoco nasal spray in pediatric epilepsy patients
Neurelis said that it has initiated the Stellina Phase 1/2a trial of Valtoco diazepam nasal spray in epilepsy patients between the ages of 2 and 5. The news comes almost exactly one year after the company announced plans for the pediatric trial and a future sNDA submission. Valtoco has been approved in the US for the treatment of seizure clusters in patients 6 years … [Read more...] about Neurelis initiates Phase 1/2a study of Valtoco nasal spray in pediatric epilepsy patients
Kinaset initiates Phase 1b trial of its KN-002 dry powder JAK inhibitor
Kinaset Therapeutics said that dosing is underway in a Phase 1b SAD/MAD study of its KN-002 dry powder JAK inhibitor, which it is developing for the treatment of asthma and COPD. The trial is expected to enroll 48 healthy volunteers in the single ascending dose portion of the study and 32 asthma patients in the multiple ascending dose part of the study. The … [Read more...] about Kinaset initiates Phase 1b trial of its KN-002 dry powder JAK inhibitor
VistaGen initiates second Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder
VistaGen Therapeutics said that it has initiated the PALISADE-2 Phase 3 clinical trial of its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). The company initiated the PALISADE-1 trial of PH94B for SAD in May 2021. Topline results from that trial are expected in mid-2022, with results from the PALISADE-2 trial expected later that … [Read more...] about VistaGen initiates second Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder