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Crinetics Pharmaceuticals (Nasdaq:CRNX) just Publish initial data Data from four patients has been released from a Phase 2, open-label study using the company’s drug Atumernanth (CRN04894) to treat patients with congenital adrenal hyperplasia. This is earlier than the scheduled data presentation embargo date, which is expected to take place at ENDO between June 1 and 4, 2024. Despite the publication of such data, this does not mean that there are not other triggers related to this program. Investors cannot take advantage of it. Because, as I said earlier, this only released the initial four patients at the time of submission. New data to be presented at the ENDO 2024 medical meeting will include data from her six patients in Cohort 1, followed by data from other patients in Cohort 2.
We cannot guarantee this, but Other cohorts with higher doses may have better efficacy. In addition to this promising catalyst, there are two others to consider. The first is a new drug application (NDA) submission for paltusotine for the treatment of patients with acromegaly, expected in late 2024. Progress is also being made in the development of this same drug for the treatment of patients with carcinoid syndrome. Having said that, another catalyst is to begin a Phase 3 study of this particular program by the end of 2024. With several catalysts underway and two different drug molecules advancing in the pipeline, I believe investors can benefit from the potential gains.
Atumernant is a new drug in the pipeline with great potential
The great thing about Crinetics Pharmaceuticals is that they’re not just relying on developing Paltusotine to treat acromegaly and carcinoid syndrome. The company is also developing another drug known as Atumelnant (CRN04894). This particular drug is being developed to treat patients with congenital adrenal hyperplasia. These patients are being treated with Atumelnant in a Phase 2 open-label study. Congenital adrenal hyperplasia (CAH) is a disease in which a genetic change prevents the adrenal glands from producing hormones. That’s because the adrenal glands themselves are involved in producing hormones such as:
- Cortisol
- Mineralocorticoids (such as aldosterone)
- Androgens (such as testosterone)
In patients with CAH, the adrenal glands lack sufficient enzymes to produce these necessary hormones.
The phase 2 open-label trial enrolled 10 patients with classic CAH who had been receiving stable GC replacement therapy for at least 6 months. The patient received oral atumernant once daily for 12 weeks. As mentioned above, the data was released ahead of the embargo date scheduled to be presented at his upcoming ENDO 2024 conference. However, the published data were only for her first four patients in cohort 1. Additionally, these patients received oral atumernant 80 mg once daily for only 12 weeks. Despite receiving such a low dose, the patient was able to experience a reduction in her two key disease biomarkers: her A4 and her 17-OHP. If the levels of these biomarkers are high, the patient may be suffering from her CAH. Therefore, the goal is to reduce both of these metrics. That being said, the reductions in these indicators throughout the study were as follows:
- A4 size reduced from 74% to 99%
- 17-OHP reduction rate ranges from 68% to over 99%
In conclusion, by administering 80 mg of Atumernan once a day, Rapid and sustained suppression of both of these biomarkersIf this data is made public and presented at an upcoming medical conference, what triggers remain for investors? This data only covers a portion of the patients in Cohort 1. The remaining six patients in Cohort 1 and additional patients in Cohort 2 will To be announced at ENDO 2024. Specifically, the latest poster presentation show will be published on his June 3, 2024 from 12:00 PM to 1:30 PM ET.
finance
by 10-Q SEC Filings, Crinetics Pharmaceuticals had $901 million in cash, cash equivalents, and investments as of March 31, 2024, and the cash on hand is due to the completion of the private placement agreement. This is because it helped raise approximately $350 million. We have enough cash for the long term, especially to overcome some of the factors mentioned above. The company believes its cash reserves will be sufficient to fund his operations until 2028. The company’s cash burn is approximately $54.1 million per quarter.
Risk to business
There are several risks investors should be aware of before investing in Crinetics Pharmaceuticals. The first risk to consider concerns the recently published four-patient data from a Phase 2 open-label study of Atumelnant to treat patients with CAH. While the first four patients in cohort 1 saw rapid and sustained reductions in A4 and 17-OHP throughout the study, there is no guarantee that the same will be seen in the other six patients in the exact same cohort. Additionally, there is no way of knowing whether a higher dose would produce better data compared to 80 mg once daily.
A second risk to consider relates to Paltusotine’s NDA with the FDA for the treatment of patients with acromegaly. Even if submission is achieved, there can be no assurance that the agency will expect a starter application, nor that the company will ultimately be able to obtain FDA approval of the drug for the treatment of this patient population.
A third risk to consider concerns ongoing discussions with the FDA. The company plans to move forward with the use of partosotine to treat patients with carcinoid syndrome in a Phase 3 trial. However, there is no assurance that the FDA will allow it to proceed to such a late-stage trial. Crinetics reported positive topline results in an open-label Phase 2 trial using the drug to treat these patients, but it is possible that the FDA will only now allow late-stage trials so quickly.
Conclusion
Crinetics Pharmaceuticals has successfully advanced the use of Atumelnant for the treatment of patients with CAH. This is evidenced above by the rapid and sustained reduction in A4 and 17-OHP achieved with only 80 mg of the drug administered once daily. Where is the potential? Well, it remains to be seen whether the other six patients in Cohort 1 who received the same dose will achieve similar results. Additionally, it will be important to see if a higher dose would result in even better reductions in terms of both of these biomarkers. This biotech company has built a pipeline full of multiple drugs targeting different agents. That being said, the value doesn’t just come from Atumelnant for CAH. This brings us to two other catalysts related to the development of Paltusotine for the treatment of patients with acromegaly and carcinoid syndrome. Speaking of which, both of these other catalysts are also expected by the end of 2024.
