Aadi Bioscience Inc’s stock witnessed a significant downturn following the release of results from a planned interim analysis of its tumor-agnostic PRECISION1 trial. This trial focuses on evaluating the efficacy of nab-sirolimus in patients with TSC1 or TSC2 inactivating alterations. The company, after closing Thursday’s trading at $5.37, experienced a substantial decline, with the stock opening at $2.34.
At the time of this publication, Aadi Bioscience Inc stock (AADI) has witnessed a decline.
Aadi Bioscience Inc
Current Price: $2.36
Change : -3.02
Change (%): (-56.15%)
Volume: 2.0M
Source: Tomorrow Events Market Data
The interim analysis encompasses data from the initial third of trial participants (n=40) who underwent a minimum follow-up period of 4.5 months. The analysis includes investigator-assessed response and safety, separately analyzed in each TSC1 and TSC2 arms.
For patients with tumors harboring pathogenic inactivating alterations in TSC1, the analysis revealed a 26% Overall Response Rate (ORR). This included five partial responses (PR), with four confirmed responses and one unconfirmed response (uPR). All responses were sustained at the time of data cutoff, and the patient with uPR remained on treatment, awaiting a confirmatory scan. Additionally, nine patients exhibited stable disease (SD), with three lasting for more than or equal to six months, resulting in a clinical benefit rate of 42%. Notably, 60% of responders experienced a tumor reduction of over 50%.
In contrast, patients with tumors harboring pathogenic inactivating alterations in TSC2 demonstrated an 11% ORR, which included two PRs with one confirmed and one uPR. Twelve patients had SD, with three lasting for more than or equal to six months, yielding a clinical benefit rate of 28%. Responses were observed in one epithelial carcinoma and one sarcoma. Importantly, no new safety signals were identified, and no grade-four treatment-related events or deaths occurred.
The PRECISION1 trial, which enrolls a total of 80 patients, is set to undergo a two-thirds interim analysis in the third quarter of 2024. This analysis will be based on an independent radiological review, considering a follow-up period of at least six months for all patients. The trial is anticipated to conclude by the end of 2024, with results expected in early 2025.
Investors are closely monitoring the developments surrounding Aadi Bioscience Inc as the company navigates through the interim analyses of the PRECISION1 trial, aiming to provide valuable insights into the potential of nab-sirolimus in treating patients with TSC1 or TSC2 inactivating alterations. The outcome of the trial and its subsequent impact on the stock’s performance will likely be of significant interest to stakeholders in the biopharmaceutical sector.
