Revive Therapeutics has partnered with Attwill Medical Solutions to advance the clinical and commercial development of Revive’s innovative lyophilized formulation of Bucillamine.
Specialising in life sciences, Revive Therapeutics is dedicated to the exploration and creation of therapeutics to address medical requirements and rare disorders.
Revive CEO Michael Frank said: “The formulation development of our novel lyophilized formulation of Bucillamine at the University of Waterloo is near complete, and we are now entering into the next phase of our product development cycle and preparing for a clinical trial.
“AMS specialises in contract manufacturing of lyophilization and related processing of pharmaceuticals, making it an ideal partner for Revive in achieving its clinical and commercial objectives.”
AMS is one of the leading medical lyophilization facilities in the US, boasting cGMP-compliant facilities and dryers capable of lyophilizing volumes ranging from 1 to 2,000 litres per cycle.
The collaboration between Revive and AMS aims to facilitate the transfer of technology for the lyophilized formulation of Bucillamine from the University of Waterloo (UW) to AMS.
Following the successful technology transfer, AMS will initiate the development and clinical trial manufacturing of lyophilized Bucillamine under GMP standards. The company anticipates having its innovative lyophilized Bucillamine ready for clinical evaluation by 2024.
To summarize, the UW research team has made significant strides in enhancing the solubility of Bucillamine. The subsequent lyophilization process has more than doubled its solubility, unlocking the therapeutic potential of Bucillamine.
Notably, this lyophilized form may aid in advancing the research collaboration with Defence R&D Canada – Suffield, an agency of the Canadian Department of National Defence, to assess Bucillamine as a potential treatment for nerve agent exposure.
Additionally, Revive and AMS are set to devise plans for potential commercial scale-up to address public health emergencies, including those related to pandemic influenza, emerging infectious diseases, and medical countermeasure incidents and attacks.
Furthermore, given Bucillamine’s potent antioxidant and anti-inflammatory properties, it holds promise for orphan indications in rare inflammatory disorders such as ischemia-reperfusion injury (organ transplantation). In recognition of its potential, the FDA granted orphan drug designation for Bucillamine in this context in 2022.
