Item 8.01. Other Events.
On April 3, 2023, the Company announced topline results of its Phase 2 clinical trial of pomotrelvir for the treatment of patients with mild to moderate COVID-19. Pomotrelvir did not achieve the primary endpoint as measured by the proportion of participants below the limit of detection for infectious SARS-CoV-2 by infectious virus assay (IVA) on day three of treatment with pomotrelvir versus with placebo. Pomotrelvir did not demonstrate meaningful improvement over placebo in reduction from baseline of SARS-CoV-2 infectious virus titer by IVA or in the reduction from baseline or proportion achieving undetectable viral load by quantitative reverse transcriptase polymerase chain reaction measured from mid-turbinate swabs.
The median time to alleviation of the 14 U.S. Food and Drug Administration guidance-defined and 12 (excluding loss of taste and smell) targeted COVID-19 symptoms were eight days and seven days, respectively, in both pomotrelvir and placebo treated participants. The median time to alleviation of five key COVID-19 symptoms (cough, stuffy or runny nose, low energy or tiredness, sore throat, and feeling hot or feverish) was six days in both pomotrelvir and placebo treated participants with median times to resolution of each individual key symptom being two to five days and similar for pomotrelvir and placebo treated participants.
There were no deaths and no participants experienced progression to severe COVID-19. There were no drug-related adverse events, serious adverse events, or adverse events leading to discontinuation in either treatment arm. Pomotrelvir was well tolerated, with treatment-emergent, drug-related nausea occurring in 3.1% of participants, which represented the only adverse event occurring in greater than 2% of pomotrelvir-treated participants.
The Phase 2 double-blind, randomized study evaluated the antiviral activity, safety, and clinical efficacy of pomotrelvir compared with placebo in non-hospitalized, symptomatic, otherwise healthy adults with mild-to-moderate COVID-19 and a confirmed positive SARS-CoV-2 test. Participants were dosed orally twice-daily at 700 mg (2 x 350 mg tablets) with food for five days.
Based upon the topline results from the Phase 2 clinical trial, the Company has decided to suspend further clinical development of pomotrelvir and the Board has initiated a review of a range of strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination or other transaction. There can be no assurance that this review process will result in the Company pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms or at all. The Company does not intend to comment further unless or until the Board has approved a definitive course of action, the review process is concluded, or it is determined that other disclosure is appropriate.
Forward Looking Statement
This Current Report contains statements that relate to future events and expectations and, as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this Current Report, the words “believe,” “intend,” “may,” “plan,” “possible,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to the Company, may identify forward-looking statements. All statements that reflect the Company’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding the Company’s preliminary cash, cash equivalents and short-term investments as of March 31, 2023, the percentage of positions affected by the Plan, and the estimated restructuring charges associated with, and the time frame for completion of and recognition of charges associated with, the Plan, and the Company’s intent to review strategic alternatives. Any forward-looking statements in this Current Report are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this Current Report, including, without limitation, risks associated with: the completion of the quarterly review of the Company’s financial statements for the quarter ended March 31, 2023; volatility and uncertainty in the capital markets for biopharmaceutical companies; the Company’s ability to execute its planned exploration and evaluation of strategic alternatives; availability of suitable third parties with which to conduct contemplated strategic transactions; whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all; whether the Company’s plans will provide the intended benefits and cost savings; and other risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and other filings subsequently filed with the U.S. Securities and Exchange Commission. The statements in this Current Report speak only as of the date of this Current Report, even if subsequently made available by the Company on its website or otherwise. The Company disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law.