-Phase 2-Ready Drug Candidate Offers Potential to Greatly Broaden the Acute Ischemic Stroke Population Who Can Benefit from Thrombolytic Therapy-
Columbus, OH (May 9, 2023): Basking Biosciences (Basking), a clinical-stage biopharmaceutical company, today discussed the development status of BB-031, the company’s novel, RNA-based thrombolytic for use in patients experiencing acute ischemic stroke, at the Locus Walk RNA Innovation Conference, held virtually. BB-031, a rapid onset, short-acting agent, is an RNA aptamer targeting von Willebrand Factor (vWF), a key structural component of thrombi and driver of blood clotting. Uniquely, the thrombolytic activity of BB-031 is designed to be quickly neutralized in the event of bleeding using a complementary agent, BB-025, which Basking is developing in tandem. If successfully developed, BB-031 offers the potential to greatly broaden treatment to the 80-85% of patients suffering ischemic stroke who cannot benefit from the currently available acute therapies; thrombolytic drugs or mechanical thrombectomy.
BB-031 is a Phase 2-ready drug candidate, having successfully completed non-clinical studies in multiple gold-standard animal models and a Phase 1 clinical safety study in healthy volunteers. Non-clinical results showed the ability of BB-031 to quickly recanalize blocked blood vessels in the brain as late as six hours after stroke onset and to demonstrate reduced infarct volume on MRI in all models. Results of the Phase 1 study showed BB-031 to be safe and well tolerated, with no significant or treatment-emergent adverse events. Complete inhibition of platelet function at all doses tested was observed, as was dose-dependent duration of platelet function inhibition and time to return to normal clotting.
“RNA aptamers have a number of characteristics that make them exceptionally well suited for treating acute thrombosis,” said Richard Shea, Chief Executive Officer of Basking. “Aptamers bind their targets with high affinity and specificity, have low inherent toxicity and low or no immunogenicity. We believe that these factors, combined with the excellent thrombolytic profile that we have already demonstrated for BB-031, make this agent an outstanding RNA-based drug candidate for use in the treatment of ischemic stroke, an area of significant unmet medical need.”
Mr. Shea concluded, “We are now preparing to initiate a Phase 2 clinical proof-of-concept study in patients suffering an acute ischemic stroke with the ultimate goal of being able to safely and effectively treat a much greater number of stroke patients than is possible today.”
The Locust Walk RNA Innovation Conference is hosted in partnership with Dr. Frank Slack, Director of the Beth Israel RNA Medicine Initiative, and Dr. Phil Zamore, Director of the UMass Chan RNA Medicine Institute.
Acute ischemic stroke (AIS) is the leading cause of combined mortality and morbidity worldwide, and 87% of all strokes are ischemic. According to WHO, 15 million people suffer strokes each year, leading to more than 5 million deaths. Global incidence is rising with aging populations. In the USA, annual direct stroke-related medical costs are projected to exceed $184 billion and indirect costs due to premature mortality and loss of productivity to reach $56 billion by 2030. Intravenous recombinant tissue plasminogen activator (rtPA) and endovascular mechanical thrombectomy are the therapies available to treat acute ischemic stroke. Unfortunately, both treatments are limited by time and clot location respectively, leaving almost 85% of patients without any acute intervention.
Basking Biosciences is a clinical-stage company founded to solve the biggest need in ischemic stroke therapy – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries within a significantly extended therapeutic window than currently approved therapies, and whose activity can be quickly reversed in the event of bleeding. The company is developing BB-031, a first-in-class RNA aptamer targeting von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process. The company is also developing BB-025 in tandem, a complementary rapid-acting reversal oligonucleotide capable of quickly neutralizing BB-031 pharmacological activity. Non-clinical research in multiple gold-standard animal models demonstrated that BB-031 quickly recanalized blocked blood vessels in the brain, as late as six hours after stroke onset. Basking has successfully completed a Phase 1 single-ascending dose safety study with BB-031 and is initiating a Phase 2 clinical proof-of-concept study in patients suffering from an acute ischemic stroke with the ultimate goal of extending the therapeutic window for thrombolysis compared to currently approved therapies.
Founded in 2019, Basking is currently supported by Broadview Ventures, Rev1 Ventures, Viva BioInnovator and Viva Ventures Biotech. For more information, please visit our website at http://www.baskingbiosciences.com.