- Altimmune Inc ALT revealed it would hit the pause button on its immunomodulatory candidate for COVID-19, dubbed T-COVID, citing enrollment challenges.
- The Phase 1/2 trial for T-COVID, single-dose intranasal therapeutic for early COVID-19, completed dosing in two of the three planned dose cohorts but could not fill the third cohort with patients over the age of 65 or with increased risk due to pre-existing comorbidities.
- Hence, the company will terminate further enrollment and evaluate options for future T-COVID development following an assessment of the available data and discussions with its partners.
- Altimmune is also ditching AdCOVID COVID-19 nasal vaccine candidate after early trial results disappointed.
- In a phase 1 study of 80 healthy adults between ages 18 and 55, the vaccine did spur some antibody response but not enough to keep pace with the vaccines already approved for emergency use.
- AdCOVID's road to the clinic was delayed in December after the FDA put a hold on the IND application after citing issues with the vaccine's trial protocol and CMC issues.
- Altimmune opened enrollment in Phase 1 in February, giving patients either one or two doses of the vaccine at three different dose levels.
- Meanwhile, Altimmune said it plans to pivot focus back to ALT-801, a candidate for obesity, and HepTcell, a peptide-based therapy for obesity and liver diseases.
- The company recently posted encouraging 6-week interim data on early-stage weight loss drug ALT-801.
- Price Action: ALT shares are down 37.3% at $10.22 during the premarket session on the last check Wednesday.
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