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Tharimmune (THAR) Up on Positive Data From Pipeline Candidate

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Tharimmune, Inc. (THAR - Free Report) announced data from an early-stage study on TH104 and the development timeline for a phase IIa study in chronic pruritis in primary biliary cholangitis (“PBC”) patients. Shares of this clinical-stage biotechnology company gained 21.9% on these updates.

TH104 is embedded with an active pharmaceutical ingredient on a proprietary transdermal, buccal film, which makes it easy for it to adhere to the inside of the mouth. TH104 has a dual mechanism of action affecting receptors known to suppress chronic, debilitating pruritis or “uncontrollable itching.”

The first phase I study was a single-dose, single-center, open-label, randomized, 2-way crossover study of TH104 transmucosal buccal film compared with a tablet formulation marketed in Europe (but not the United States). The study had a 14-day washout period involving 12 healthy volunteers under fasting conditions.

The study achieved its primary outcome of predictable pharmacokinetic profiling with favorable safety and tolerability. Secondary objectives included establishing the relative bioavailability of TH104 and evaluating its' tolerability for potential value in clinical efficacy studies.

The second phase I study was a single-dose, single-center, open-label, parallel-group design with 2 treatment arms involving different formulations of TH104 with variable pH in sixteen healthy volunteers under fasting conditions. The primary outcome measure was to determine the effect of pH in the transmucosal buccal film on the drug absorption profile evaluated from serial blood sample collections.

The results from this study showed that the evaluation of TH104 transmucosal film did not have a significant impact on the performance of the film as measured by drug concentrations in human plasmas when given as an equal-labeled dose in two different pH formulations delivered buccally to healthy volunteers under fasting conditions.

Shares of Tharimmune have plunged 64% year to date compared with the industry’s decline of 22.9%.


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Concurrently, Tharimmune stated plans to provide topline data from a phase I pharmacokinetic bridging study in the United States to evaluate the absolute bioavailability of TH104 as well as assess the safety and tolerability of the formulation in 2024. The study is designed as a single-dose, single-center, open-label, randomized 2-way crossover study of TH104 transmucosal buccal film and an intravenous dose of drug administered under fasting conditions in 2024.

The data from the completed phase I study, along with the phase I pharmacokinetic bridging study in the United States, may complement a phase IIa efficacy study that Tharimmune anticipates launching next year in chronic pruritis in PBC.

The study is planned as a multiple ascending dose trial to assess the safety and tolerability of TH104. It will also evaluate the change from baseline in the validated endpoint for pruritis studies.

The successful development of TH104 will be a significant boost for Tharimmune.

Tharimmune might evaluate TH104 in treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other liver-related and non-liver-related conditions, including fatty and alcoholic hepatic diseases, non-alcoholic liver diseases and certain types of hepatitis.

We remind investors that Tharimmune acquired the license for TH104 from Avior Inc.

Zacks Rank and Stocks to Consider

Tharimmune currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the overall healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) , Dynavax Technologies (DVAX - Free Report) and Acadia Pharmaceuticals (ACAD - Free Report) . Ligand sports a Zacks Rank #1 (Strong Buy), and DVAX and ACAD each carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.39 in the past 90 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.44. Ligand beat earnings estimates in each of the last four quarters. The company has delivered an earnings surprise of 67.19%, on average.

Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 28.1% year to date.

Loss estimates for Acadia have narrowed to 33 cents from 41 cents for 2023, while the earnings estimate for 2024 is currently pinned at 94 cents per share. ACADIA shares have gained 39% year to date.

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