Starpharma says Viraleze is effective in COVID-19 patients. Picture Getty
Health & Biotech
Starpharma (ASX:SPL) announced that its anti-viral spray, Viraleze, shows antiviral efficacy in COVID-19 patients.
Results from the Viraleze post-market study demonstrated that Viraleze reduced SARS-CoV-2 viral load in the nose, increased the rate of virus clearance from the nose, improved key symptoms of COVID-19, including loss of smell (anosmia), and was well-tolerated.
The double-blind, placebo-controlled clinical study had enrolled a total of 222 participants eligible for safety analyses, with 197 of these participants having SARS-CoV-2 infection.
Participants in the study were randomised in a 1:1 ratio, and self-administered Viraleze or a placebo nasal spray four times daily for seven days.
Results reported include:
– Viraleze achieved the primary endpoint of the study, which is a statistically significant reduction in SARS-CoV-2 viral load, in the group aged 45 and over.
– Less than 24 hours after starting dosing, Viraleze reduced SARS-CoV-2 viral load in the nose by 80% from baseline in participants aged 65 and over.
– And Viraleze reduced viral load in the full study population ie all patient age groups, although the difference vs placebo was not statistically significant.
Starpharma says these findings are consistent with its previous non-clinical in vivo and in vitro studies of Viraleze in SARS-CoV-2 and other cold/respiratory viruses, including influenza.
The company also said results from this study will provide significant clinical evidence of the performance of Viraleze in humans, which will particularly support its regulatory pathway in the EU.
The SPL stock price rose 3.5% this morning on the news.
Neurotech (ASX:NTI) announced Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) scheme clearance by the TGA to commence a Phase I/II clinical trial.
The trial will investigate the use of NTI164 in paediatric patients with Spastic Diplegia Cerebral Palsy (Spastic CP) – the most common form of CP, representing up to 80% of cases.
The Phase I/II trial is proposed to be a single-arm, open-label clinical trial that will recruit up to 14 paediatric patients with a clinical diagnosis of Gross Motor Function Classification System (GMFCS) severity of 2-3, and non-ambulant Spastic CP patients.
To be conducted at Monash Medical Centre, the trial’s primary endpoint is the Caregiver Priorities and Child Health Index of Life with Disabilities Questionnaire – which evaluates caregivers’ perceptions of health-related quality of life, and caregiver impact in children with CP.
Secondary endpoints include safety and the effect of NTI164 on pain, sleep, seizure frequency, dystonia (involuntary muscle contraction) and spasticity.
The company anticipates commencing the Phase I/II trial in the first half of this calendar year.
The NTI share price jumped over 2% on the news this morning.
Meanwhile, PharmAust (ASX:PAA) says the US FDA Office of Orphan Products Development had asked the company for additional data to support the monepantel (MPL) Orphan Drug Designation (ODD) application for the treatment of Motor Neurone Disease (MND)/ALS.
PharmAust had earlier submitted the request for ODD in November 2023 to the FDA.
The application was based on MPL’s pre-clinical mechanistic data, which demonstrated that MPL can induce autophagy in diseased cells.
The FDA’s reply today clearly stated that it could not grant the ODD at this stage, and instead requested that PAA provide pre-clinical data in a relevant animal model or clinical data from human trials – in order to establish the potential for the drug to be effective in MND/ALS.
The FDA has also provided PharmAust with a pathway to address the absence of clinical data by submitting an amendment to the ODD request, rather than reapplying with an entirely new application.
PharmAust’s Phase 1 MEND Study top-line results are on track to be released before the end of this current quarter, and the company now plans to submit those results to the FDA to support the ODD.
“Over the coming weeks, we will continue our communication strategy with the FDA about the ODD and the pre-IND meeting for our adaptive Phase 2/3 study,” said PharmAust’s CEO, Dr Michael Thurn.
The PAA share price fell -6% on the news.
At Stockhead we tell it like it is. While Neurotech and PharmAust are Stockhead advertisers, they did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
