Summary: Apnimed has acquired global rights to develop and commercialize sulthiame, a carbonic anhydrase inhibitor with promising phase 2 results for OSA, through a joint venture with Shionogi, aiming to expand its portfolio of oral therapies for sleep-related breathing disorders.
Key Takeaways:
- Apnimed and Shionogi will develop sulthiame within the Shionogi-Apnimed Sleep Science Joint Venture for Obstructive Sleep Apnea and other sleep-related breathing indications.
- Sulthiame has completed phase 2 studies in Europe and has a mechanism of action that is differentiated from AD109, Apnimed’s lead asset for OSA.
Pharmaceutical company Apnimed Inc, which is assembling a portfolio of first-in-class oral drugs that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, has acquired the intellectual property and exclusive global rights to develop and commercialize sulthiame, a differentiated carbonic anhydrase inhibitor, in the broad field of sleep apnea and sleep-related breathing diseases, from Desitin Arzneimittel GmbH.
Apnimed will develop sulthiame with Shionogi & Co Ltd through their joint venture, Shionogi-Apnimed Sleep Science (SASS). Sulthiame is currently approved for non-sleep-related diseases in several regions outside the United States and has completed phase 2 trials for OSA in Europe. Sulthiame has not yet been approved for any use in the United States.
“This transaction represents an exciting opportunity to develop a promising new compound for OSA that is designed with a different mechanism of action from our lead program, AD109,” says Larry Miller, MD, CEO of Apnimed, in a release. “Sulthiame’s differentiated mechanistic design offers the potential to expand the reach of treatment and further accelerate the adoption of oral therapies for OSA.”
“We look forward to adding another compelling asset to the SASS pipeline,” says John Keller, PhD, senior vice president, R&D supervisory unit and pharmaceutical technology research division, Shionogi & Co, in a release. “Our joint venture, combining the scientific and medical resources of Apnimed and Shionogi, represents the most robust global effort to bring new oral, pharmacologic treatments to patients with OSA.”
“Desitin is proud to have contributed to the ongoing clinical development of sulthiame, an investigational compound with compelling phase 2 efficacy data and a favorable safety profile,” says Philipp Bloching, MD, CEO of Desitin, in a release. “Sulthiame is now in the best possible hands to successfully complete its development and bring benefits to patients with OSA and other sleep-related breathing indications around the world.”
Under the terms of the agreement, Desitin will receive an undisclosed upfront payment, future milestone payments, and royalties on future sales. As part of the transaction, SASS will also explore the use of sulthiame in additional sleep and breathing diseases including obesity hypoventilation syndrome.
Sulthiame is an investigational, generally well-tolerated oral carbonic anhydrase inhibitor that is designed to restore breathing stability, which is often a contributing mechanism in people with OSA. Sulthiame has completed two phase 2 trials in over 300 European OSA patients, studied for a duration of up to 3 months. It has been used clinically in non-sleep indications outside the United States and has demonstrated a favorable safety profile to date.
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