Pinned straw:
Todays announcement is an expansion/amendment to the Cooperative Research & Development Agreement (CRADA) with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and relates to the only Department of War laboratory suitable for testing Galidesivir due to it’s Biosafety Level 4 (BSL-4) containment. The initial agreement was announced in March and it is unclear to me at least what the changes are on the initial agreement because that was pitched as meeting the needs of the company for the Animal Rule development pathway.
The dosing study is planned to start next quarter with topline results expected in H2 CY26, which is a 6 month slip on the timeline for the February investor presentation shown below.
Feb24 Investor Presentation:
None the less, having the study locked in and ready to go is a good thing for the company. The dosing study is a critical step before the efficacy study on which the NDA will be based, allowing for improved planning of that study and enhancing an understanding of the performance of the treatment at different doses. In addition, it will provide more efficacy data, adding to the relatively low sample size of previous testing (but outstanding results). This will provide investors and investigators with a lot more information on how the final efficacy testing is likely to work out, so that is the big news we are waiting on.
There is a webinar on Friday, 11am AEST (Webinar Registration - Zoom) which you can register or and I expect we will get more details and insights on progress, but for now it seems to be progressing, if a bit slower than initially planned.
Disc: I own RL+SM
Webinar Notes
If you own or are interested in ILA I would highly recommend viewing the recording of todays webinar (out later today supposedly). The slide deck was presented mostly as is, but the real value was in the question section with great questions and some indications that there may be some value inflecting outcomes around Ebola, which precede those expected with the top line results from Marburg expected at year end.
My scrappy notes, additional information and impression of any emphasis or new insights:
· Budibugyo Ebola has 30-50% fatality rates which is actually a problem because it allows for much greater spread. ILA may be able to help (question that given the small quantities on hand and planned which just cover testing needs, this may change once the GMP facility is up and running towards the end of the year). May dove tail into an opportunity to do an in human Phase 2/3 in Ebola so jump to NDA in a similar time period as currently expected for Marburg.
· Broadest spectrum antiviral activity (Filoviruses)… so do the other cover specific diseases without strain restraints? Need to look more closely at near competitors.
· Loading dose looks to have a significant impact on survivability.
· Dose optimisation protocol: 16, 4 no drug, 4*4 different dose post exposure time. Delay in starting due to challenge getting monkeys… They will need more monkeys for the pivotal study but they sounded surprised it took as long as it did for the does testing, so will presumably build in the time needed and it is less likely to cause further delays.
· Patent protection not an issue for stockpile drugs due to Animal Rule. Many off patent stock pile drugs don’t face generic competition. Once an effective stockpile drug is developed there is little incentive for competition given risk, cost of testing plus difficulty to get the government to switch.
· Higher dose size on previous animal tests is still only about half the dose used in human trials, so dosing change is not an issue for FDA approval.
· Testing is not against Budibugyo strain of Ebola, but Galidesivir shown good effectiveness across Filoviruses, but they plan on doing some specific testing against Budibugyo. That said they indicated that it may be being used in Africa now (unofficially), but due to not being GMP or approved, they are looking for work arounds to use officially and have it provide any support for an approval pathway.
· 101 program completed P2 with good results for Dangi fever, working on new formulations (oral/IV), update next week.
· Survival result by end of year for dosing studies, but full result early next year. Kick of pivotal study in next 12 months. The updated survival results will be price sensitive and may provide a solid lift.
Disc: I own SM+RL, a small top up today at what is still below my average buy.