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TFF Pharmaceuticals (TFFP) Completes Enrollment in Phase I Study
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Clinical-stage biopharmaceutical company, TFF Pharmaceuticals, Inc. (TFFP - Free Report) , announced that the enrollment has been completed for the phase I study on tacrolimus inhalation powder.
The company also announced positive preliminary data from its phase I study of tacrolimus inhalation powder, which showed that inhalation of the same achieved systemic therapeutic drug levels.
Single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg and 5.0 mg were administered to healthy subjects in the single ascending dose (SAD) phase of the study. The mean trough blood levels reached 1.1 ng/mL in subjects that received inhaled tacrolimus in the low-dose group while blood levels in the highest dose group reached 10.0 ng/mL.
There were no significant differences in systemic exposure when subjects received inhaled tacrolimus dosing at 2.5 mg while fasting or 30 minutes after a high-fat meal. This shows that delivery by inhalation was not associated with food effects in this cohort of subjects.
The repeated dosing of inhaled tacrolimus every 12 hours over 7 days demonstrated that subjects receiving doses of 0.5 mg twice daily and 1.0 mg twice daily achieved 12-hour trough steady-state blood levels that averaged 6.8 ng/mL and 14.9 ng/mL, respectively, in the multiple ascending dose (MAD) phase.
The data indicates inhaled tacrolimus can be effectively delivered to solid organ transplant patients with lower total doses than the oral forms of the drug due to the formulation’s enhanced bioavailability and the lack of food effects.
The company expects to report top-line safety data in the third quarter. Per the company, the strong bioavailability data will support initiation of a clinical study in lung transplant patients in the second half of 2021. TFF Pharmaceuticals expects that the dosing regimen for the study in lung transplantation will be tailored to potentially provide effective immunosuppression in the lung while reducing renal toxicities.
The stock has declined 32.1% so far this year compared with the industry’s decrease of 3.1%.
Image Source: Zacks Investment Research
The company has two lead drug candidates — voriconazole inhalation powder and tac-lac inhalation powder. It is developing two additional in-house programs — inhaled voriconazole for the treatment of pulmonary-based fungal infections and inhaled niclosamide for the treatment of COVID-19 infections.
The successful development of these candidates will be a boost for the company.
Zacks Rank & Stocks to Consider
TFF Pharmaceuticals currently carries a Zacks Rank #5 (Strong Sell).
Image: Bigstock
TFF Pharmaceuticals (TFFP) Completes Enrollment in Phase I Study
Clinical-stage biopharmaceutical company, TFF Pharmaceuticals, Inc. (TFFP - Free Report) , announced that the enrollment has been completed for the phase I study on tacrolimus inhalation powder.
The company also announced positive preliminary data from its phase I study of tacrolimus inhalation powder, which showed that inhalation of the same achieved systemic therapeutic drug levels.
Single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg and 5.0 mg were administered to healthy subjects in the single ascending dose (SAD) phase of the study. The mean trough blood levels reached 1.1 ng/mL in subjects that received inhaled tacrolimus in the low-dose group while blood levels in the highest dose group reached 10.0 ng/mL.
There were no significant differences in systemic exposure when subjects received inhaled tacrolimus dosing at 2.5 mg while fasting or 30 minutes after a high-fat meal. This shows that delivery by inhalation was not associated with food effects in this cohort of subjects.
The repeated dosing of inhaled tacrolimus every 12 hours over 7 days demonstrated that subjects receiving doses of 0.5 mg twice daily and 1.0 mg twice daily achieved 12-hour trough steady-state blood levels that averaged 6.8 ng/mL and 14.9 ng/mL, respectively, in the multiple ascending dose (MAD) phase.
The data indicates inhaled tacrolimus can be effectively delivered to solid organ transplant patients with lower total doses than the oral forms of the drug due to the formulation’s enhanced bioavailability and the lack of food effects.
The company expects to report top-line safety data in the third quarter. Per the company, the strong bioavailability data will support initiation of a clinical study in lung transplant patients in the second half of 2021. TFF Pharmaceuticals expects that the dosing regimen for the study in lung transplantation will be tailored to potentially provide effective immunosuppression in the lung while reducing renal toxicities.
The stock has declined 32.1% so far this year compared with the industry’s decrease of 3.1%.
Image Source: Zacks Investment Research
The company has two lead drug candidates — voriconazole inhalation powder and tac-lac inhalation powder. It is developing two additional in-house programs — inhaled voriconazole for the treatment of pulmonary-based fungal infections and inhaled niclosamide for the treatment of COVID-19 infections.
The successful development of these candidates will be a boost for the company.
Zacks Rank & Stocks to Consider
TFF Pharmaceuticals currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the sector include Zoetis Inc. (ZTS - Free Report) , Halozyme (HALO - Free Report) and Bayer Aktiengesellschaft (BAYRY - Free Report) , all carrying a Zacks Rank #2 (Buy), at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zoetis’ earnings estimates are up 8 cents for 2021 and 9 cents for 2022 over the past 90 days. The stock has rallied 21.1% year to date.
Halozyme’s earnings estimates are up 18 cents for 2021 and 11 cents for 2022 over the past 60 days.
Bayer’s earnings estimates are up 3 cents for 2021 and 7 cents for 2022 over the past 60 days. The stock has gained 1.8% year to date.