- ResApp gets clearance from the US FDA
- Immutep is granted patent in Japan
- Paradigm Biopharma to commence Phase 3 trial
ResApp Health (ASX:RAP) announced that SleepCheckRx has received 510(k) clearance as a prescription-only Software-as-a-Medical Device from the US FDA.
SleepCheckRx is an at-home sleep test that screens adults for the risk of moderate to severe obstructive sleep apnoea by analysing breathing and snore sounds recorded on an Apple iPhone.
It requires no accessories or hardware other than an iPhone to make the assessment.
ResApp says that sleep apnoea is the most common sleep breathing disorder, and affects more than three in every 10 men and nearly two in every 10 women. Studies have shown that up to 80% of people with sleep apnoea are undiagnosed and untreated.
The FDA clearance means that SleepCheckRx can now be made available to patients via a prescription from their healthcare provider.
Gaining this clearance will also enable ResApp to commercially market the test in the whole of the US.
“With more than 20 million American adults suffering from sleep apnoea and the majority of those not knowing that they have the condition, this clearance unlocks a significant market opportunity for ResApp,” said CEO Tony Keating.
“By using SleepCheckRx, physicians will have the opportunity to screen their patients conveniently and quickly for sleep apnoea, helping their patients take the first step to getting treatment,” he added.
Meanwhile, Immutep (ASX:IMM) has been granted a Japan patent entitled “Anti- LAG-3 Antibodies”.
The claims of the patent relate to Immutep’s pre-clinical product candidate IMP761, pharmaceutical compositions comprising IMP761, and the use of the compositions in the treatment of T-cell mediated inflammatory and autoimmune diseases.
This new Japanese patent will give Immutep protection until 1 September 2036, and follows the grant of the equivalent European patent announced in October 2020.
Immutep CEO, Marc Voigt, said: “We continue to take important steps to protect our pre-clinical candidate IMP761, which is the first product candidate to act as a LAG-3 agonist, a novel mechanism of drug action that we believe can act directly to treat the root cause of autoimmune diseases.”
ResApp and Immutep prices today:
Other notable ASX healthcare announcements today
Paradigm says it has received UK regulatory and ethics approvals to proceed with the Para_OA_002 Phase 3 clinical trial to evaluate knee osteoarthritis (OA).
UK participant screening and enrolment will now begin imminently.
Paradigm also reported that the clinical trial has been given regulatory approval from Health Canada as well.
An ethics submission has now been made, and once granted, Paradigm will activate clinical sites to begin participant screening and enrolment for the Phase 3 study in Canada.
Alterity Therapeutics (ASX:ATH)
The neurodegenerative diseases specialist announced the first patient has been dosed in the company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating Parkinsonian disorder.
While it is similar to Parkinson’s disease, MSA progresses more rapidly and causes profound disability. There are currently no known causes or specific risk factors associated with the disease.
“Dosing of our first patient is a significant milestone for Alterity as we look to bring a potential new treatment option to individuals living with MSA,” said David Stamler, CEO of Alterity.
“This is just the first step as we expect to expand enrolment in multiple regions over the second half of this year,” he said.