Alar Pharmaceuticals TPEX:6785 Stock Report

Less than half of directors are independent

No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. No highly experienced directors. 3 independent directors (4 non-independent directors). was the last director to join the board, commencing their role in . The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.

Alar Pharmaceuticals Inc. Announces Significant Progress on Developing Long-acting Buprenorphine Injectable ALA-1000

Alar Pharmaceuticals Inc. announced the completion and positive results of ALA-1000 SAD study (A1-19-P01). The results represent the first demonstration of safety, tolerability, and pharmacokinetic (PK) durability for ALA-1000, a subcutaneous LAI formulation releasing buprenorphine, in patients with opioid use disorder (OUD) administered subcutaneously. Based on the data of safety assessments, subcutaneous injections of ALA-1000 were well-tolerated in all dose-escalation cohorts. All the drug-related adverse events (AEs) were mild or moderate in severity and were consistent with expected opioid withdrawal and known pharmacology effects of buprenorphine. No significant or unexpected safety findings were identified in this first-in-human study. The injection site reactions were scored as none mostly or mild rarely and resolved within 1 hour mainly. No subjects discontinued the study due to injection site reactions. ALA-1000 achieved anticipated PK profile in human, i.e., consistent buprenorphine-release with therapeutically effective plasma levels for at least 3 months but low fluctuation and without dose dumping, significant initial burst. The secondary endpoints regarding efficacy demonstrated that patients who received single ALA-1000 injection at target dose remained relatively mild withdrawal signs and symptoms (mean score < 5 on Clinical Opiate Withdrawal Scale [COWS]) and opioid craving (= 14 mm on the Opioid Craving Visual Analog Scale [VAS]), and displayed = 80% negative urine opioids toxicology results during the outpatient phase (up to Day 175). Alar has completed a successful end-of-phase 2 meeting with US FDA for ALA-1000. The phase III pivotal trial to support NDA application is planned to initiate this year. ALA-1000 is the first, three-month Buprenorphine LAI administered subcutaneously entering the clinical stage. The proposed buprenorphine systemic exposure resulting from the ALA-1000 injection remains effective over 3 months per administration and benefits patients by reducing the burden of daily administration, improving patient compliance, and diminishing the concerns of misuse, abuse, and accidental pediatric exposure.

Alar Pharmaceuticals Inc., Annual General Meeting, May 25, 2021