Full Press Release Details
Completes Analysis of Ratutrelvir Clinical Study in PAXLOVID -Eligible and Ineligible COVID-19 Patients and Provides
Updates for Additional Indication for Tivoxavir Marboxil as a Prophylactic Treatment for Seasonal Influenza
results with ratutrelvir confirm a differentiated profile versus PAXLOVID with fewer adverse events
and no viral rebounds with equivalent time to sustained symptom resolution; results were recapitulated in PAXLOVID -ineligible
patients, representing a significant population with no effective treatment options
Pre-clinical analysis of tivoxavir marboxil
tablets demonstrated significantly increased exposure compared to a prototype formulation with predicted 28-day protection in humans from
influenza infections against a wide range of seasonal and pandemic variants
PK study of compressed tivoxavir marboxil
tablets submitted under open IND in Australia and preparations are underway for a Human Influenza Prophylaxis Challenge Study in the UK
NEWTOWN, PA, February 19, 2026 (GLOBENEWSWIRE)
-- Traws Pharma, Inc. (NASDAQ: TRAW, "Traws Pharma", "Traws" or "the Company"), a clinical-stage
biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today
announced the completion of the clinical analysis of its 90-patient, open-label Phase 2 study of ratutrelvir, an investigational oral,
ritonavir-free Mpro/3CL protease inhibitor, versus PAXLOVID in patients with mild-to-moderate COVID-19, together with
a single arm in PAXLOVID -ineligible subjects. Patients ineligible to receive PAXLOVID are frequently at
elevated risk for severe disease and require suitable, safe and effective treatment options. Ratutrelvir has the potential to address
this gap in care and may be a valuable therapeutic option.
Designed as an active-controlled comparator trial
versus PAXLOVID (nirmatrelvir/ritonavir), the study evaluated patient-reported symptom outcomes, safety, and real-world
usability. A separate treatment arm was comprised of patients ineligible for ritonavir-boosted regimens due to contraindications or clinically
significant drug-drug interactions.
Patients in the ratutrelvir arm received ratutrelvir
600 mg orally once daily for 10 days, while patients in the comparator arm received PAXLOVID , administered as nirmatrelvir
300 mg twice daily plus 100mg ritonavir twice daily for 5 days, consistent with approved prescribing information. Patients receiving ratutrelvir
who were ineligible for PAXLOVID reported fewer treatment-related adverse events (3 events in 30 subjects, 10%) compared
to subjects receiving PAXLOVID , (7 events in 30 subjects, 23.3%), and symptoms resolved more quickly in subjects taking
ratutrelvir who were ineligible for PAXLOVID , compared to PAXLOVID treatment (HR, 1.31; 95% CI, 0.78-2.20,
"From a clinical perspective, the completed
data analysis confirms that ratutrelvir may provide a meaningful benefit across a broader range of patients, including those who are unable
to receive ritonavir-boosted therapy," commented Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. "The
favorable tolerability profile, together with a shortened time to symptom resolution and the absence of viral rebound events in ratutrelvir-treated
patients, encourages and supports the continued clinical evaluation of ratutrelvir in both acute COVID-19 and in studies designed to better
understand its potential impact on longer-term outcomes."
"The combination of early and sustained
symptom improvement, extended dosing duration, absence of viral rebound observed to date, and favorable tolerability supports the strategic
hypothesis that ratutrelvir may have utility in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID)," commented Dr. Redfield.
"By enabling earlier and potentially more complete viral clearance, without the limitations associated with ritonavir boosting,
ratutrelvir may offer a differentiated approach to both acute COVID-19 treatment and prevention of longer-term complications".
Tivoxavir Marboxil Update
The Company additionally announced progress in
advancing an additional indication for tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor, as a
once-monthly, single oral tablet for prevention of seasonal influenza.
In prior Phase 1 studies in healthy volunteers,
an unformulated powder-in-capsule formulation provided blood levels exceeding 3X EC50 against a basket of common seasonal influenza
variants up to 22 days after drug administration. A tablet formulation has been evaluated pre-clinically and demonstrated a 30% increase
in exposure compared to the unformulated prototype. "Modelling of these data suggests that the tablet formulation should provide
28-day coverage, enabling a once-a-month prophylactic treatment," commented C. David Pauza, PhD, Chief Science Officer of
Traws Pharma. "We intend to advance these findings into a healthy volunteer study to be conducted under an open IND in Australia
and, if the extended exposure is confirmed, we intend to progress TXM into a Seasonal Human Influenza Virus Prophylaxis Challenge Study,"
Dr. Pauza continued.
Separately, the FDA informed the Company that
its US IND for tivoxavir marboxil was being placed on clinical hold due to concerns with the mutagenicity data package. The FDA intends
to communicate its concerns formally, together with suggested mitigation steps, by March 16, 2026. Dr. Redfield commented,
"This IND application was originally filed to enable a complete review by the Biomedical Advanced Research and Development Authority
(BARDA) of the Company's application for inclusion in the strategic stockpile for the treatment of avian influenza. While the clinical
hold does not directly impact ongoing and planned studies outside of the United States, Traws Pharma appreciates the FDA concern and is
working to mitigate this issue in our clinical development plan."
"Collectively, the advancement of our antiviral
portfolio provides a number of significant value inflection points and could provide treatment and prevention options for clinically important
viral diseases," commented Iain Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma.
Ratutrelvir is an investigational oral, small
molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir.
It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does
not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions1,
and potentially enable wider patient use. Phase 1 data also show that ratutrelvir's pharmacokinetic (PK) profile demonstrated maintenance
of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for
ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID2. Industry
data indicate that COVID treatment represents a potential multi-billion dollar market opportunity3.
About Tivoxavir Marboxil
Tivoxavir marboxil (TXM) is an investigational
oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and
seasonal influenza. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including
a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate
that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion
dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion
in drug stock piling initiatives4,5, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We
believe that these data support further development of TXM as a treatment for bird flu.
Third-party products mentioned herein are the
trademarks of their respective owners.
About Traws Pharma, Inc.
Traws Pharma is a clinical stage biopharmaceutical
company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates
antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases.
We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant
virus strains that threaten human health: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a
ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a
single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN).
Traws is actively seeking development and commercialization
partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws' website at
For more information, please visit www.trawspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange
Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements
regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness,
safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company
has attempted to identify forward-looking statements by terminology including "believes", "estimates", "anticipates",
"expects", "plans", "intends", "may", "could", "might", "will",