Incannex engaged inhalation drug formulation specialist Vectura to manufacture IHL-216A to be used in clinical trials

2021-06-22 03:00:06 (AET) by Ring Zhang   239


Incannex Healthcare Limited (ASX: IHL), an ASX-Listed cannabinoid and psychedelic medecine development company, announced that it has engaged drug manufacturer and developer Vectura Limited to develop the specific formulation for IHL-216A to be used in the pivotal clinical trials required for product registration.

Incannex Healthcare Limited (ASX: IHL), an ASX-Listed cannabinoid and psychedelic medecine development company, announced that it has engaged drug manufacturer and developer Vectura Limited to develop the specific formulation for IHL-216A to be used in the pivotal clinical trials required for product registration.

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According to the announcement, Vectura will perform formulation screening studies, undertake manufacturing process optimisation studies, perform a stability assessment on the lead formulation, and manufacture a lab scale batch of IHL-216A in support of toxicology studies.

Furthermore, Vectura also agreed to provide navigation for IHL-216A and its inhalation delivery mechanism to obtain regulatory approval.

Vectura Limited is a state-of-art contract development and manufacturing organisation (CDMO) specialising in inhaled drugs and their associated delivery products. Vectura Limited has partnered with pharmaceutical giants, such as Sandoz, Novartis and Bayer, to contribute to the creation of 13 successful inhaled medicines, which have cumulatively generated US$11 billion in sales and have been used by 10 million patients since launch until 2020.

IHL-216A is Incannex’s proprietary inhaled drug comprised of CBD and any volatile anesthetic agents, including isoflurane. The ingredients have been proven to have synergy effect to reduce neuronal damage, neuroinflammation and behavioral deficits that are consequences of traumatic brain injury (TBI) in studies.

It is worth noting that IHL-216A has been designed to satisfy the World Anti-doping Authority (WADA) and Australian Anti-Doping Authority’s (ASADA) specifications for use by athletes at risk of TBI and Chronic Traumatic Encephalopathy.

The drug formulation studies conducted by Vectura will be conducted in parallel with the in vivo study at Monash Trauma Group in Monash University that the company announced in March. Appointing Vectura helps ensure the specific formulation and delivery mechanism are ready for the advancement of the pivotal clinical trials once the in vivo study is finalised.

TBI is sudden damage to the brain caused by a blow or jolt to the head, common causes include car crashes, fall, and sports. TBI accounts for approximately 10 million deaths in the world yet currently has no registered pharmaceutical agents approved for the treatment. The current major treatment for TBI is through surgical intervention, which involves the removal of skull segments to reduce intracranial pressure.


Source: IHL ASX Announcement


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