Avance Clinical is the premium Australian CRO for international biotechs that effectively leverages Australia’s supportive regulatory environment and 43.5% Government rebate on clinical spend to execute high quality trials with maximum return on investment.
Intranasals Positioned to Reach $71 Billion Market Value
With the global intranasal drug delivery market estimated to reach up to $71 billion over the next five years, Avance Clinical is seeing an increase in biotech clinical trials targeting this growing market demand. North America is predicted to be the largest market, with China and India the fastest growing in APAC.
Avance Clinical CEO Yvonne Lungershausen said the demand for intranasal delivery is seen across all therapeutic areas for new chemical entities as well as repurposing of currently approved medications.
“The COVID-19 era has made mucosal immunity a driver for a new generation of intranasal vaccines. Intranasal administration is becoming a preferred delivery route driven by the rise in home healthcare, self-administration, and increasing demand in the aged and paediatric care,” Lungershausen said.
In the race to service the intranasal products market, biotechs are increasingly looking to Avance Clinical to expedite their trials. Avance Clinical has become known internationally for its intranasal product expertise, with a reputation for successful ethics approvals and efficient trial execution.
Avance Clinical offers ClinicReady, a dedicated scientific and regulatory affairs service, which supports clinical programs to achieve approval in an average of 4-5 weeks from submission.
Avance Clinical’s Chief Scientific Officer Dr. Gabriel Kremmidiotis said:
“We have extensive experience preparing preclinical datasets that meet international regulatory guidelines. This enables us to achieve fast local regulatory approvals with the majority of our submissions requiring only 1 round of comments from the Ethics Committee (IRB).”
“The Avance team demonstrated flexibility and a solution-oriented attitude in working with us towards obtaining rapid ethics approval, thereby facilitating trial initiation in a timely and efficient manner.”
Dr. Russell Rother, President and Chief Operating Officer, Tetherex Pharmaceuticals
Instranasal Clinical Trials Have Specific Safety Assessment Requirements
In preparing clinical trial protocols and executing clinical trials involving intranasal agents, Avance Clinical’s team has the required knowledge and expertise for trial planning and conduct. Avance Clinical is able to advise their clients on safety assessments and procedures as well as trial participant questionnaires ensuring comprehensive clinical profiling of the product.
“Intranasal delivery can present specific challenges. Prior experience is essential in maximizing the dataset captured in a phase I trial, which essentially forms the foundation for any further development of the product,” said Dr Kremmidiotis.
Spotlight on Avance Clinical Clients Developing Intranasal Products
Odyssey Group International
Odyssey Group International, is developing a novel, life-saving product to treat concussions. In animal studies, intranasal delivery demonstrated rapid, broad brain biodistribution, reducing swelling and inflammation.
Avance’s ClinicReady team played a key role in assisting Odyssey with gaining ethics approval for a clinical trial to evaluate this product.
Avance Clinical’s Principal Scientific and Regulatory Affairs Specialist Dr. Jorgen Mould commented:
We are pleased to deliver for Odyssey on achieving Ethics approval for their first in human trial. The PRV-002 submission met the strict standards set by the Ethics Committee.”
Tetherex Pharmaceuticals is developing an adenoviral vector vaccine (a genetically modified organism product) for the treatment of COVID-19. The treatment is designed for intranasal delivery which is expected to provide front-line defense against COVID-19 in airway tissues, the site of virus entry into the body. The vaccine is currently undergoing safety testing in healthy volunteers.
The Avance Clinical ClinicReady team worked with Tetherex on the development of the protocol and the Investigator’s Brochure while concurrently working with the Office of Gene Technology Regulator (OGTR) in obtaining the necessary licenses to enable importation of the product to Australia for the purpose of clinical trial evaluation. Avance Clinical is accredited by the OGTR, which enables it to support the execution of trials evaluating genetically modified organism products in Australia. This support involves the application and acquisition of a product specific license from the OGTR and the monitoring and management of the clinical site’s compliance to that license.
Atossa Therapeutics is a US-based company developing an intranasal delivery product for the treatment of COVID-19. This product is complementary to vaccines and aims to treat the disease by reducing the ability of the virus to invade. The product is designed to act as a barrier by neutralizing the virus. The product is a combination of agents previously shown in independent settings to be safe in humans while displaying physicochemical properties which, when combined, form a multifactorial barrier for viruses in the respiratory system.
The ClinicReady team mined the scientific literature for all available information on each of the components comprising the Atossa product in order to capture all relevant, previously published data, on the efficacy and safety of these components both in preclinical animal species and in human trials. Combining these publicly available datasets with relevant and appropriate justification from FDA and EMA guidelines, the ClinicReady team was able to deliver ethics approval for proceeding with evaluation of the Atossa product in the clinic.