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$DMAC -
DiaMedica is a very small company focused on developing a recombinant version of KLK1 called DM199 for two very large indications. DM199 is thought to release nitric oxide and prostaglandins in synergy. https://twitter.com/MattBiotech/status/1328430191933149185?s=20
DiaMedica is a very small company focused on developing a recombinant version of KLK1 called DM199 for two very large indications. DM199 is thought to release nitric oxide and prostaglandins in synergy. https://twitter.com/MattBiotech/status/1328430191933149185?s=20
In stroke, KLK1 could improve circulation and prevent inflammation and cell death. In May, DiaMedica reported what I found to be very compelling, placebo controlled data in AIS. There is a very large addressable market here not covered by tPA or MT.
The stroke data showed an improvement in both "total recoveries" and mortality. A possible Phase 3 trial might use one of these endpoints and exclude MT and possibly tPA eligible patients for data integrity. The Phase 2 data also allowed for decent financing terms.
In Q1 2021 we will hopefully get FDA guidance on a seamless Phase 2b/3 trial that is registrational plus decisions on BTD/fast track. But putting aside stroke, there is a good chance we get a DKD readout in late Q1 and the stroke data gives us some readthrough.
DiaMedia is testing DM199 for CKD in three cohorts: IgA nephropathy, African Americans with CKD, and DKD. The first two cohorts have been plagued with enrollment problems but the third cohort is enrolling fast and should be finished enrolling any day now.
We are likely to get DKD data in Q1 2021, and while open label, it should be the clearest signal that DM199 can increase eGFR in DKD patients and lead to trial design for a Phase 2b or pivotal Phase 3 trial. What’s that worth?
The company is also well protected with IP and manufacturing. My theory here: If I’m wrong on DKD, I’m not wrong on stroke. If I’m wrong on both, well, I missed on an $80M MktCap company that I sized knowing the risk. I can live with that.
