NEWTOWN, Pa. - Traws Pharma, Inc. (NASDAQ: TRAW), a clinical-stage biopharmaceutical company, has announced positive topline results from its Phase 1 clinical trial for ratutrelvir, a potential oral treatment for COVID-19. The study, which involved healthy volunteers, reported no treatment-related adverse events and consistent plasma levels of the drug within the predicted therapeutic window.
Ratutrelvir, an oral inhibitor of the Main protease (Mpro) of SARS-CoV-2, is being developed as a once-daily, single-dose therapy for a duration of 10 days. The Phase 1 trial, conducted in Australia, included 56 participants and showed that the drug could be administered without the need for ritonavir, a metabolic inhibitor that can cause drug-drug interactions and severe side effects.
Traws Pharma's CEO, Werner Cautreels, PhD, expressed optimism about ratutrelvir's potential, highlighting its ability to maintain plasma concentrations above the effective concentration against a comprehensive panel of SARS-CoV-2 viruses. The company has selected the dose for its upcoming Phase 2a study, slated to begin in the first half of 2025.
Despite the availability of approved antiviral therapies, COVID-19 was a significant cause of mortality in the United States in 2023, with approximately 50,000 deaths. Traws Pharma's Chief Medical Officer, Robert R. Redfield, MD, emphasized the need for simple treatment regimens, particularly for high-risk patients and those with underlying medical conditions.
Preclinical studies presented at the International Conference on Antiviral Research in 2024 (ICAR2024) showed ratutrelvir's differentiated activity against drug-resistant SARS-CoV-2 variants. Furthermore, the drug demonstrated higher levels in the lung compared to plasma, which could reduce the likelihood of clinical rebound.
The potential market opportunity for COVID-19 treatments remains substantial, and ratutrelvir is positioned as a competitor to existing Mpro inhibitors like Pfizer (NYSE:PFE)'s Paxlovid. Unlike Paxlovid, ratutrelvir does not require ritonavir co-administration, potentially allowing for broader patient use.
Traws Pharma focuses on developing oral small molecule therapies for respiratory viral diseases and cancer. The company's viral respiratory disease program includes another Phase 1 oral small molecule, tivoxavir marboxil, targeting influenza.
This news is based on a press release statement and is intended for informational purposes. Traws Pharma has made forward-looking statements regarding ratutrelvir's development and potential, which are subject to risks and uncertainties. The company continues to pursue its clinical trials and regulatory plans for the drug candidate.
In other recent news, Traws Pharma is grappling with potential Nasdaq delisting due to an equity shortfall of approximately $105.5 million, falling short of the required $2.5 million equity threshold. The company has until October 7, 2024, to submit a plan to regain compliance. In another significant development, Traws Pharma announced a merger with Onconova Therapeutics (NASDAQ:TRAW) and Trawsfynydd Therapeutics, which is expected to boost Traws Pharma's financial position with an estimated cash balance of $28 million.
On the personnel front, Traws Pharma welcomed Luba Greenwood to its Board of Directors, following the departure of long-serving Director James J. Marino. The company also reported the immediate resignation of Steven M. Fruchtman, its President and Chief Scientific Officer, Oncology.
In a bid to maintain robust financial practices, Traws Pharma has engaged KPMG LLP as its new independent registered public accounting firm. Furthermore, the company amended its corporate bylaws, lowering the quorum requirement for stockholder meetings. These are the recent developments in Traws Pharma's operations.
InvestingPro Insights
Traws Pharma's positive Phase 1 results for ratutrelvir come at a crucial time for the company, as reflected in recent financial data from InvestingPro. The company's market capitalization stands at $10.48 million, indicating its current valuation in the biotech sector. Despite the promising clinical trial results, Traws Pharma faces financial challenges, as evidenced by its negative operating income of -$20.65 million in the last twelve months as of Q2 2024.
InvestingPro Tips highlight that Traws Pharma holds more cash than debt on its balance sheet, which could be advantageous for funding further clinical trials and development of ratutrelvir. This financial cushion may prove crucial as the company moves towards its Phase 2a study in 2025.
Another InvestingPro Tip suggests that net income is expected to grow this year, which aligns with the potential progress of ratutrelvir and could reflect investor optimism about the drug's prospects. However, it's worth noting that the company is currently not profitable over the last twelve months, underscoring the importance of successful drug development for its financial future.
Investors considering Traws Pharma should be aware that InvestingPro offers 12 additional tips, providing a more comprehensive analysis of the company's financial health and market position.
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