Awakn Life Sciences: Tackling Britain's Addiction Problems With MDMA and Ketamine

Awakn Life Sciences Corp. AWKN, a biotech company that develops psychedelics treatments for addiction, began trading on the NEO exchange last week.

The company is directing much of its efforts toward building an infrastructure to provide Ketamine and MDMA treatment for patients struggling with addiction disorders. It will set up most of its operations in the UK before moving to other territories.

“Twenty percent of the global population is suffering from an addiction. Be it to alcohol, opioids, prescriptions, nicotine, gambling addiction, pornography addiction, sex addiction…” said CEO Anthony Tennyson in an interview with Benzinga.

Awakn recently closed a CA$8.3 million ($6.7 million) private raise, totaling CA$13.5 million ($10.9 million) in private capital proceeds.

Awakn In A Nutshell

“To keep it simple,” says Tennyson “we do two things: we do development and we do delivery.”

For the psychedelics industry to run smoothly, four core pillars need to be guaranteed. These, according to Tennyson, are: “Compound, therapy, therapists and clinical environment. And those need to be delivered together.” 

In the area of development, the company’s pipeline for the short and medium-term is focusing on developing protocols that can lead to the approval of generic MDMA and Ketamine in the UK. The company is running a separate program on a parallel track that aims to place its own novel psychedelic molecules through the clinical trial pipeline.

From the delivery side, Awakn is currently building a psychedelics-assisted therapy clinic in Bristol and plans to launch branches in London and Manchester before the end of the year.

After that, it plans to establish more clinics in Europe but chooses to stay away from North America due to the high-risk profile of its commercial environment. However, Tennyson recognizes that North America still offers significant opportunities from an IP perspective.

“I want to provide licensed access to our IP to the 125,000 addiction treatment practitioners in the US.”

Democratizing Access To Psychedelics Treatment

Tennyson describes the company’s core motivation as an effort to democratize access to psychedelic medicines for addiction disorders.

“In order to help as many people as possible, the insurance markets have to reimburse,” he says

“I don't want to charge people out of their pockets. We want the insurance companies. We want the medical insurance. We want the healthcare business to support us.”

In order to achieve that, the company is pushing to get MDMA and Ketamine approved for addiction indications in the UK.

Research Into Ketamine and MDMA With A Focus On Addiction

The company’s scientific team boasts an impressive track record researching psychedelics for addiction treatment. Dr. Ben Sessa, a co-founder and chief medical officer, is a leading researcher in the use of MDMA for alcohol use disorder. Prof. Celia Morgan is Sessa’s counterpart in Ketamine research. Renowned psychedelics researcher Prof. David Nutt heads the company’s research arm.

While the Multidisciplinary Association for Psychedelic Studies (MAPS) leads MDMA research in the U.S., the UK still offers opportunities for companies looking to study the compound, which was discovered in 1912 and is now a generic drug.

MAPS’ research is expected to receive FDA approval in late 2022 or 2023 for use in the U.S.

However, “there's no equivalency from FDA to [Britain’s] MHRA or to [Europe’s] EMA,” Tennyson explained.

“So it's back to that pivotal trial. You’ve got to run those pivotal trials in each location, in each of the major geographies.”

Later this year, Awakn plans to launch a phase 2b clinical trial to test the effectiveness of MDMA-assisted therapy for the treatment of Alcohol Use Disorder, which will be led by Nutt.

The company expects to bring this therapy research through phase 3 trials and eventual market authorization, which could allow for the application of these therapies in its own clinics under health insurance coverage.

In March, the company acquired the rights for six years worth of proprietary research by Nutt, including newly discovered modes of action for MDMA. This research will inform the company’s drug development efforts in the long term.

On Monday, Awakn announced filing patent applications in the U.S. for two next-generation novel MDMA-derived chemical entities called AWKN001 and AWKN002.

Ketamine Research: Awakn will be able to deliver Ketamine in an off-label capacity in its own clinics since it is a generic drug that is already approved for anesthesia.

However, the company is considering pushing Ketamine for alcohol use disorder through phase 3 trials, because, if approved by regulators, the UK public healthcare system will be able to support the treatment.

Awakn has purchased the IP for a phase 2 a/b trial using Ketamine for reduction of alcoholic relapse to be led by Morgan. Tennyson thinks pursuing approval of Ketamine for this indication could be the right move, although the drug is generic. In the meantime, the company plans to use the protocols developed through this research to apply treatment in its own clinics.

 

Photo: Awakn CEO Anthony Tennyson, courtesy photo.