Veru presented meaningful results from the Phase Ib/II clinical study of Sabizabulin in men with metastatic castration-resistant prostate cancer.
Sabizabulin Mechanism of Action: Tubulin inhibitors; Tubulin polymerization inhibitors
Sabizabulin is an orally administered, first-in-class small molecule that targets, binds, and crosslinks the alpha and beta-tubulin subunits of microtubules and intermediate filaments of cells, causing cytoskeleton disruption. Furthermore, sabizabulin causes apoptosis or cell death by cleaving poly ADP ribose polymerase (PARP), which is important for DNA repair in cancer cells. In terms of the drug's efficacy, the data presented at the ASCO 2022 Conference was quite significant, achieving an overall response rate of 20.7% for all patients who have received at least 63mg dose. Moreover, the median radiographic progression-free survival was 11.4 months. In terms of safety, the dosing of sabizabulin was well tolerated, with no clinically significant reports of neurotoxicity or neutropenia. Importantly, these data also supported the initiation of the ongoing Phase III VERACITY trial of sabizabulin metastatic castration-resistant prostate cancer (mCRPC) in men who have progressed on an androgen receptor targeting agent.
“The Phase 1b/2 study of sabizabulin clinical trial showed a significant 11.4 months median radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer that has progressed while receiving an androgen receptor targeting agent.” –Expert Opinion.
Looking at the positive findings of the sabizabulin ASCO 2022, we can anticipate that these early results demonstrated that sabizabulin appears to be very active in these patients, and the drug has the potential to fulfill an urgent unmet medical need. The treatment approaches in mCRPC have evolved substantially over the past decades, beginning with the introduction of docetaxel and transformed with subsequent data from trials of novel hormonal agents, including abiraterone and enzalutamide. Other medications utilized in these patients, such as docetaxel chemotherapy or other androgen targeting therapies, often achieve a median progression-free survival of 3 to 4 months as a baseline. As a result, these findings show that sabizabulin looks to be quite active in these patients and that continuous oral treatment with an acceptable safety profile is possible. Moving on to the CRPC market, which is already quite crowded, there is a lot of competition ongoing between the emerging drugs, so the drug needs to have an acceptable safety profile and better efficacy to make their valuable space in the market. Seeing the scenario for Sabizabulin, it is an intriguing first-in-class drug that could be added to the treatment armory for mCRPC.
Few competitors such as Bayer, Merck Sharp & Dohme, Pfizer, Janssen, Clovis Oncology, Bristol-Myers Squibb, AstraZeneca, Janssen Research & Development, Roche, Modra Pharmaceuticals, Candel Therapeutics, Eli Lilly, and others are also evaluating their lead candidates in different stages of clinical development for CRPC.