Noticias y eventos de Aardvark Therapeutics, Inc. (AARD)AARDAardvark Therapeutics, Inc.

Aardvark Therapeutics Reports ARD-101 Clinical Trial Data

Aardvark Therapeutics reported exploratory efficacy data from its previously terminated Phase 3 Hunger Elimination or Reduction Objective, or HERO, trial and open-label extension, or OLE, trial. As previously announced, Aardvark unblinded the data accumulated across both the HERO trial and OLE trial to assess the totality of available efficacy and safety data to inform the path forward for ARD-101. A summary of the available dataset from the Phase 3 HERO trial and OLE trial can be found below. The HERO trial randomized 67 of the planned 90 participants and was terminated early. As such, all efficacy data are considered exploratory. At week two of dose escalation on ARD-101, a modest reduction in Hyperphagia Questionnaire for Clinical Trials, or HQ-CT, score versus placebo was observed in the HERO trial. Upon discontinuation of ARD-101, the average HQ-CT score of the ARD-101 treatment group returned to near baseline, while the placebo-treated group had less rebound toward baseline. In the OLE cohort, participants who switched from placebo to ARD-101 had an observed average reduction of 6 points in HQ-CT score. A similar pattern was observed for caregiver and clinician outcome measures, assessed by Caregiver Global Impression and Clinician Global Impression Severity scores, respectively. ARD-101 was generally well tolerated, with most adverse events being mild to moderate. One cardiac serious adverse event was observed in the HERO trial at 800 mg twice daily, or BID, in a participant who was also taking pitolisant, a CYP2D6 substrate. The FDA concurred that this event is related to a drug-drug interaction. Aardvark plans to resume dosing of ARD-101 in patients with PWS at a dose lower than the 800 mg BID dose studied in the Phase 3 HERO trial and OLE trial, pending discussion with the FDA. The company plans to request a meeting with the FDA to align on its Phase 3 program, with the goal of advancing ARD-101 toward potential regulatory approval.

Aardvark Therapeutics Lifts Clinical Hold on ARD-101

Aardvark Therapeutics announced that the FDA has lifted the clinical hold on the company's investigational new drug application for ARD-101 for the treatment of hyperphagia in PWS. On February 27, Aardvark voluntarily paused dosing in the Phase 3 Hunger Elimination or Reduction Objective, or HERO, trial and its open-label extension, or OLE, trial following reversible electrocardiogram, or ECG, changes observed during routine safety monitoring in a separate study in healthy volunteers. In May, the FDA placed a clinical hold on the HERO trial and OLE trial. In alignment with the FDA, the company conducted a thorough ECG study in additional healthy volunteers and an in vitro cardiac sodium channel study. No cardiac events were observed in the recently completed ECG study at ARD-101 doses of 200 mg and 400 mg twice daily. Aardvark plans to resume clinical development of ARD-101 in patients with PWS following additional anticipated engagement and alignment with the FDA on the Phase 3 trial design. As previously announced, Aardvark unblinded the data accumulated across both the HERO trial and OLE trial to assess the totality of available efficacy and safety data. "We are pleased that the FDA has lifted the clinical hold on ARD-101, allowing us to continue advancing our clinical development program," said Tien Lee, founder and CEO of Aardvark. "With strong alignment and collaboration with the FDA, we completed the work necessary to allow for the resumption of clinical studies. People living with PWS and their families continue to face profound unmet need, and we look forward to working with the FDA as we advance ARD-101."

Aardvark Cash and Investments Decrease to $73.9M

As of June 30, Aardvark had cash, cash equivalents and short-term investments of $73.9M, compared to $91.2M as of March 31. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations into late 2027. "Patients and families in the PWS community are at the center of every decision we make, and our team is laser focused on establishing a clear path forward for ARD-101 in PWS," said Tien Lee, founder and CEO of Aardvark. "Over the last several months, we have continued to work collaboratively with the FDA. Additionally in the third quarter of this year, we are assessing the unblinded data from the HERO and OLE trials, which will allow us to understand the totality of the efficacy and safety results generated to date."