Cyclopharm submits formal reply to the US FDA for its proprietary functional lung ventilation imaging agent Technegas.
ASX Health Stocks: Cyclopharm sends reply to FDA, the final step before potential approval
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- Cyclopharm submits response to the US FDA
- PharmAust completes recruitment of patients in Motor Neurone Disease trial
Cyclopharm (ASX: CYC) has submitted a formal reply to the US FDA in relation to its proprietary functional lung ventilation imaging agent, Technegas.
The submission will initiate the FDA’s stated six-month review process, which is the final major approval hurdle for Technegas in the US.
Cyclopharm expects an FDA approval and the commencement of Technegas sales in the US to create an initial addressable market of US$180 million per annum for the product in the diagnosis of Pulmonary Embolism (PE).
This estimate does not include the exponentially larger potential for Technegas’ application for Beyond PE indications, including the diagnosis and management of Chronic Obstructive Pulmonary Disease, lung cancer, asthma and Long COVID.
The FDA’s CRL (or Complete Response Letter) is a substantial document, containing over 145 supporting attachments, which comprehensively addresses the definitive list of items and recommendations requested by the FDA on 25 June, 2021.
The majority and more complex elements of the response pertains to the manufacturing and product characteristics related to the components that make up the unique Technegas system.
Cyclopharm says Technegas is unique amongst lung imaging agents, and unique in the way it is viewed by the FDA.
Firstly, the FDA has deemed Technegas as a drug-device Combination Product, meaning both the Technegas particle for inhalation along with the components that are required in its manufacture and administration are evaluated together as a drug.
Secondly, given the bespoke nature of the equipment required to manufacture the elements making up the Technegas system, full outsourced contract manufacturing is not possible.
Lastly, and most importantly, the Technegas radioactive particle for inhalation is manufactured at point of care within a nuclear medicine department, and administrated to the patient within 10 minutes.
PharmAust all set for Phase 1/2 MND trial
PharmAust (ASX:PAA) has just completed enrolment of all 12 patients in Cohorts 1 and 2 for the MND (Motor Neurone Disease) clinical trial.
The company has just finished enrolling the second cohort of six patients in its Phase 1/2 clinical trial of its lead drug candidate monepantel (MPL) in MND/Amyotrophic Lateral Sclerosis (MND/ALS).
The patients are enrolled at two sites: Calvary Health Care Bethlehe in Caulfield South, Victoria, and the Faculty of Medicine and Health Research Macquarie University in NSW.
The Phase 1/2 clinical study aims to determine the tolerability, safety, pharmacokinetics and preliminary efficacy of oral MPL in individuals living with MND. The trial is open label and comprises four cohorts with escalating MPL doses.
So far the MPL tablets have been well tolerated by patients in the first and second cohorts of the trial, and the Safety Monitoring Committee will continue the assessment of safety and efficacy for each dosage.
According to the International Alliance of ALS/MND Associations, MND affects over 350,000 people globally and kills more than 100,000 people every year.
The disease is invariably fatal with the average life expectancy of someone who has MND being around 27 months.
The MND/ALS addressable market is around US$3.6 billion per annum, with current drug Riluzole already reaching ~US$1bn annual sales.
