Complete Safety Data Anticipated by End of 1Q 2022
Safety Management Committee Has Recommended 12 mg as Phase 2 Dose
Niclosamide is a Potent Inhibitor of SARS-CoV-2 with Activity Against Multiple Variants
“We are pleased with the continued progress of TFF’s internal pipeline including inhaled niclosamide, which we believe could provide a safer, convenient and effective option to treat COVID-19,” said
Originally approved as an oral anthelmintic drug by the U.S.
The Phase 1 trial consisted of a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) phase. The SAD phase of the trial consisted of single inhalation doses of 0.5, 2.0, and 6.0 mg in three cohorts of healthy volunteers, including six volunteers that will receive active drug and two that will receive placebo, while the MAD phase consisted of doses of 3.0 and 6.0 mg administered twice per day (BID) for 4.5 days (9 total doses). The Safety Management Committee has had no questions or concerns about safety and has recommended the 6.0 mg BID (12 mg total daily dose) as safe for progression into Phase 2 testing.
“As highly contagious and vaccine evasive SARS-CoV-2 variants continue to emerge, along with new restrictions on access to certain therapies previously available under Emergency Use Authorization, there is an ongoing need for accessible antiviral treatments that can be administered in an outpatient setting,” said
Following results from the Phase 1 trial, UNION Therapeutics A/S has an option to exclusively license the dry powder formulation of niclosamide and is responsible for the next phase of development.
About TFF Pharmaceuticals’ Thin Film Freezing Technology Platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.
About TFF Pharmaceuticals
About UNION Therapeutics A/S
UNION therapeutics is a privately-held, multi-asset, clinical stage, biotechnology company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with six programs in clinical development. UNION is headquartered in Hellerup,
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform and its dry powder versions of niclosamide, and the Company’s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder version of niclosamide, (ii) assuming that the Company is successful in its clinical testing of niclosamide, that the Company will be able to enter into a licensing arrangement with UNION on terms favorable to the Company, if at all, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iv) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (v) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
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Source: TFF Pharmaceuticals, Inc.
- Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs.
Sangeun Jeon, Meehyun Ko, Jihye Lee, Inhee Choi, Soo Young Byun, Soonju Park, David Shum, Seungtaek Kim. DOI: 10.1128/AAC.00819-20
- Niclosamide inhalation powder made by thin-film freezing: Multi-dose tolerability and exposure in rats and pharmacokinetics in hamsters.
Miguel O. Jara, Zachary N. Warnken, Sawittree Sahakijpijarn, Chaeho Moon, Esther Y. Maier, Dale J.Christensen, John J. Koleng, Jay I. Peters, Sarah D. Hackman Maier, Robert O. Williams III. DOI: 10.1016/j.ijpharm.2021.120701
Source: TFF Pharmaceuticals, Inc.