Achieve Life Sciences Inc (NASDAQ: ACHV) is seeing massive gains in the market this morning after releasing positive news with regard to its smoking cessation candidate, cytisine. In fact, at the time of writing this article (June 26, 11:07 AM EDT), the stock was trading at $5.46 per share after a gain of $1.66 per share or 43.68%.

ACHV Announces Positive Cytisine Results

Achieve Life Sciences is flying in the market early on this morning afte rthe company announced results from multiple drug metabolism, drug-drug interaction and transporter studies surrounding cytisine. Drug metabolism and drug-drug interactions are incredibly important when it comes to smoking cessation aids. After all, current health conditions take priority and if the smoking cessation aid has a negative interaction with other treatments, it simply will not be used.

Nonetheless, the data showed that this is not an issue for ACHV and its cytisine candidate. In fact, the data demonstrate that cytisine has no clinically significant interaction with any of the hepatic enzymes that are commonly responsible for drug metabolism. Also, the company said that the data showed no clinically significant interactions with drug transporters.

As a result, the data showes that cytisine has a high probability of being safely administered alongside other medications. In particular, because there are no clinically significant interactions with the hepatic enzyme or drug transporters, there will likely be no need to modify the dose of co-administered drugs. Of course, management at the company was excited about the data, as seen in a statement by Dr. Anthony Clarke, Chief Scientific Officer at Achieve. Here’s what he had to say:

We are very pleased with the results of these detailed studies. Smokers are as likely as anyone to take medications for a range of conditions. These results suggest that cytisine is unlikely to interfere with their ability to take other medications safely, and should help to minimize restrictions on the eligibility of subjects in our forthcoming clinical trials expected to commence later this year.

Why This News Is Significant

As we all know, any time a biotechnology company releases positive data, that data is held with high significance. However, data doesn’t always lead to nearly 50% gains. So, what’s the big deal here? Well, there are a few factors at play:

  • The Targeted Condition – The targeted condition, addiction to tobacco products, is a plague on the United States medical system. With smaking cigarettes attributing to 28.6% of cancer deaths as well as various other ailments, the market needs more options in terms of smoking cessation. As a result, if approved, the treatment has massive potential to drive revenue.
  • Key Data – As mentioned above, for a smoking cessation aid to see decent uptake, it’s important that the treatment can be taken in combination with other drugs that patients may take on a daily basis. With the data suggesting that combining cytisine with other treatmenst may be safe and avoid loss of efficacy in other co-administered drugs, the value of the asset has climbed dramatically!

What Is Cytisine

Cytisine is a drug in development to help consumers quit smoking. The treatment is a plant-based alkaloid with a high binding affinity to the nicotine acetylcholine receptor. This is believed to reduce the urge of those addicted to cigarettes to smoke.

So far, there have been two prior, large-scale Phase 3 clinical studies of cytisine, both of which yielded favorable outcomes. In fact, more than 2,000 patients have been treated in the clinical setting. Data from both of these trials was compiled to generate the results mentioned above.

Risks Associated With ACHV

While the potential reward surrounding Achieve Life Sciences could be massive, it’s always important to consider the risks when deciding whether to, or not to, invest in a stock. In this particular case, our view of the risks include:

  • Clinical Stage – It’s important to remember that Achieve Life Sciences is a clinical stage biotechnology company. As a clinical stage company, the company does not make money from any treatments currently on the market. Therefore, it is ultimately at the mercy of its investors and lenders when it comes to funding. Of course, if lenders were to lose faith for any reason, the company could fall on very hard times financially.
  • Anyting Can Happen With The FDA – While all of the data surrounding Cytisine seems positive, anything can happen with the FDA. In order for this to be a strong long term investment, it’s important that Achieve Life Sciences receives regulatory approval to market the treatment. Of course, if the FDA or any other regulatory body in other regions rejects the drug, we could see tremendous losses.

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