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View of the technical experts or scientists on board will be welcome.
The Lancet article of Phase 2 UK trial stated "SNG001 (6 MIU interferon beta-1a) or placebo were delivered via the I-neb nebuliser ".
Reading the appendix of the Lancet article it stated
The drug product was a sterile, clear and colourless, ready-to-use aqueous nebuliser solution (0.65 mL containing 12 MIU/mL IFN-ß1a) presented in a disposable glass syringe and was stored at 5±3°C.
Link
https://www.thelancet.com/cms/10.1016/S2213-2600(20)30511-7/attachment/cf46561c-62f4-4c3b-9be8-41b2d1028b61/mmc1.pdf
https://rb.gy/izysug
This made me wonder about the real dose of Synterferon delivered to the lungs as the Activ-2 and Sprinter states 5MIU. After a good search I found the answer finally in Table 2.2-1 in the FULL Activ-2 PROTOCOL document - Page 225.
FINAL DOSE delivered to lung (with 2 syringes totalling 15.6IU) is 5MIU based on scintigraphy studies.
So looks like the Philip Ineb was more potent with 60% delivery efficiency compared to the 35% of Aerogen Ultra. Surely the experts at Synairgen and Aerogen must have perhaps felt that this 1MIU less delivery per day is not a major issue ??? Apologies if this has been discussed at lengths already here. Long and strong since April 2020 and asking a genuine question.
"In prior studies SNG001 has been delivered using the Philips-I neb device which has an efficiency of approximately 60% delivery to the lung based on scintigraphy studies [23]. As a result, a single syringe of 12 MIU/mL SNG001 (0.65 mL) is estimated to deliver 3.8 MIU after taking into account emitted dose and delivery efficiency to the lung (Table 2.2-1). In the current study SNG001 will be delivered using the Aerogen Ultra device, which has an efficiency of approximately 35% drug delivery to the lung [24]. Using the Aerogen Ultra device, a single syringe of 12 MIU/mL SNG001 (0.65 mL) is estimated to deliver a dose of 2.3 MIU to the lungs after accounting for emitted dose and delivery efficiency to the lung. In this study, two syringes (1.3 mL total) will be used, similar to the Phase II UK study of SNG001, and will be expected to deliver a dose of 5 MIU to the lungs after accounting for emitted dose and delivery efficiency to the lung."
TABLE 2.2-1
Link
https://fnih.org/sites/default/files/2021-04/Protocol%20ACTIV-2-A5401%20Version%204%20dated%2031March2021_0.pdf
https://rb.gy/pzmtn9
If memory serves me right a member of the board asked this very question to Synairgen of which the response was shared here. Unfortunately I cannot remember who it was or when exacty. It was in Q4 2020 sometime.
Hopefully someone who remembers or the member sees this.
I believe someone in the guild directly asked RM about the change in nebulisers. His response was that they had received approval and had increase the dose given. The result was that 20% more of SNG001 made it to the lungs.
From memory, they also changed as Aerogen could be used whilst on Ventilator. Not so pertinent now since they discovered it's best effect is on early infection.
From memory of discussions at the time.
Aerogen is less efficient than the iNeb.
Original P3 trial had 2 dosing regimes using Aerogen, but after review and from guidance from FDA the lower doseage was droped.
The current dosing regime delivers more IFn to the lung despit the less efficient nebuliser.
The Aerogen is widely used in hospitals in our target markets, the FDA was involved in the decision to move to this device.
Good to see you posting Ghia.
Yes Ghia and thank goodness for the FDA, who cut a third off the number for our P3 trial. Without that, we would have another 4 and a half months of recruiting to do!