ACHV - Achieve: Exciting Smoking Cessation Drug Approval Could Come Soon
2023-05-28 04:39:42 ET
Summary
- Efficacy: Phase 3 ORCA-3 trial showed significant efficacy of cytisinicline in smoking cessation, reinforcing data from ORCA-2.
- Safety: Cytisinicline exhibited no serious treatment-related adverse events, implying safe long-term usage.
- Financials: ACHV's recent fundraising extends its cash runway to end of 2024.
- Investment Potential: Despite risks, robust Phase 3 data and extended cash runway make ACHV stock a potential buy.
A key update to our thesis: positive ORCA-3 trial data as expected
Achieve Life Sciences ( ACHV ) has reported compelling topline data of Phase 3 ORCA-3 study of cytisinicline. We believe this data reinforces previous findings from the Phase 3 ORCA-2 study and we remain positive about the approvability of cytisinicline moving forward with two strong Phase 3 data and robust real-world-evidence on hand.
We remind readers that the phase 3 ORCA-3 trial randomized 792 adult smokers, with an average age of 53 years and a median smoking history of 36 years, to receive 3mg cytisinicline dosed three times daily for 6 weeks or 12 weeks, or a placebo. Also, participants received standard behavioral support during the trial (which is the current standard of care).
We note that the primary endpoint was biochemically verified smoking cessation measured during the last 4 weeks of treatment, with subjects monitored for smoking cessation for 24 weeks post-randomization, which is important to show the ongoing efficacy of smoking cessation. Net-net, cytisinicline demonstrated statistically significant smoking cessation on both primary and secondary efficacy analyses compared to placebo.
We summarize the key takeaway of the study below:
| 12-Week Cytisinicline | 6-Week Cytisinicline | Placebo |
|---|---|---|
| Number of Participants | ||
| 792 | ||
| 792 | ||
| 792 | ||
| Primary Endpoint (last 4 weeks of treatment) | ||
| 30.3% (p<0.0001, Odds ratio: 4.4) | ||
| 14.8% (p=0.0008, Odds ratio: 2.85) | ||
| N/A | ||
| Secondary Endpoint (week 9 to week 24 for 12-week regimen, week 3 to week 24 for 6-week regimen) | ||
| 20.5% (p<0.0001, Odds ratio: 5.79) | ||
| 6.8% (p=0.0006, Odds ratio: 6.25) | ||
| N/A | ||
| Most Common Adverse Events | ||
| Insomnia, abnormal dreams, nausea, headache | ||
| Insomnia, abnormal dreams, nausea, headache | ||
| Insomnia, abnormal dreams, nausea, headache |
Furthermore, as expected, we find the safety data highly compelling, supporting the safe long-term usage of the drug.
Cytisinicline was well -tolerated with no serious treatment-related adverse events. Most common adverse events were insomnia, abnormal dreams, nausea, and headache.
Clean safety in smoking cessation treatment is critical as many patients may require long-term or intermittent use. High safety profiles promote better adherence to treatment and minimize harm, especially as many smokers may have existing health issues. For instance, Bupropion can increase seizure risk and cause side effects like sleep disturbances and mood changes. Varenicline can increase cardiovascular risk and cause side effects such as nausea and serious psychiatric symptoms. Given these risks, a treatment with a clean safety profile, like cytisinicline, could potentially offer a more patient-friendly option.
Financials: recent raise should add ~1 year of runway
With the recent $16m equity financing on May 2023 and $16m of existing cash (as of March 2023), we believe the company's cash runway (quarterly cash burn <8m expected as the company has already finished its major trials) will extend to YE 2024, which is an acceptable cash runway for mid-cap biotech.
Risks
For further details see:
Achieve: Exciting Smoking Cessation Drug Approval Could Come Soon