Natesto® stands as the only FDA-approved testosterone replacement therapy drug (TRT) currently on the market that is demonstrating the ability to treat men needing testosterone replacement and at the same time allow them to maintain normal sperm parameters. With the final results of AYTU's Spermatogenesis Study expected this summer, Natesto® may potentially get recognized as leading a paradigm shift in how men needing testosterone therapy get treated.Aytu BioScience's (NasdaqCM: AYTU), Natesto®, is showing best-in-class potential based on the interim results published from the company's ongoing Spermatogenesis Study. To date, Natesto® is the only FDA-approved testosterone replacement therapy drug (TRT) on the market that is showing the ability to treat men needing testosterone replacement and at the same time allow them to maintain normal sperm parameters. And, if the interim results get confirmed later this summer, Natesto® may lead a paradigm shift in how men needing testosterone get treated.
Thus far, Natesto® has generated a compelling data set that is in sharp contrast to how men are currently getting treated with leading TRT drugs. Data already published from the Spermatogenesis Study is showing that while many doctors are prescribing TRT drugs that provide long-acting doses of testosterone to treat men with Low-T, the interim results from the ongoing Spermatogenesis Study are proving that "less may be more." And, if the principal investigators from the study are proven right when the final data is released this summer, Natesto® may earn a position as both the safest and most effective TRT drug on the market for patients needing testosterone who at the same time want to maintain their fertility.
Spermatogenesis Study Close To Publishing Final Data Results
With multi-million dollar ad campaigns pushing the premise that testosterone replacement is primarily a means to increase male libido, the reality of TRT treatment is that it is a necessary and vital part of male physiology that facilitates mood, strength, sexual desire, energy, endurance, and more. But, not all TRT replacement drugs are created equal.
In fact, most all of Natesto®'s market competitors, like Androgel®, Testim®, and Axiron® provide the patient with relatively high doses of testosterone that stay in the system for long periods of time and often lead to severe side effects. So many, in fact, that the FDA has required that each of the three mentioned include a Black-Box warning on its label. Natesto® is different, however, and stands as the only FDA-approved TRT drug on the market not required to have that severe warning. But, perhaps, more importantly, the Spermatogenesis Study investigators are convinced that when it comes to TRT treatment, less testosterone per dose and shorter exposure may prove to be more beneficial compared to the higher, longer-acting doses per treatment provided from other prescribed TRT drugs. And, such a result could extend the marketability of Natesto® tremendously.
Dr. Ranjith Ramasamy, Director of Reproductive Urology at the University of Miami, for instance, recently commented on how Natesto® is distinguishing itself from market competitors. According to Dr. Ramasamy, "the levels of testosterone in men rise about an hour or 2 after administration (of Natesto®) and seem to drop off about 2 to 4 hours after the peak." This physiological event is unique to Natesto®, and he added that such a reaction "is closer to normal physiology than other delivery systems in which the levels of testosterone are pretty high during the day and therefore could lead to some of the side effects that we see with testosterone." It's a distinction that is getting the attention of prescribing physicians, perhaps leading to Natesto® posting record-breaking prescription rate growth in each of the last four quarters for AYTU.
Spermatogenesis Study Targets Younger Patients That Want To Maintain Fertility
Drilling into the specifics of the Spermatogenesis Study, the ongoing phase 4 prospective study has enrolled 56 men aged between 18 and 55 years who had low levels of testosterone (baseline mean, 233.97 ng/dL), with the median age at 37 years old. The study is evaluating and targeting for inclusion, mostly younger men that have several hypogonadal complaints, with the most common issues they face being lack of energy, fatigue, and some level of erectile dysfunction. The data already published from the study are demonstrating more than meaningful physiological results, it is also showing that along with providing men with a measured improvement of their symptoms, Natesto® is not contributing to a worsening of quality of life, a meaningful distinction from other testosterone replacement drugs that can cause severe and unintended side effects.
Perhaps the greatest strength and advantage of Natesto®, however, is that motility (live, moving sperm) was preserved in patients at a median of 51.5% after six months of therapy. That distinction is significant and is advancing the theory that Natesto® could be used in men who have low testosterone levels and are interested in preserving fertility – most men younger than 40. To support that theory, Dr. Ramasamy noted that the study results to date are proving an early confirmation of their initial hypothesis, in particular, that "less may be more." And, his interim analysis is showing that with Natesto® being a short-acting formulation of testosterone that is dosed in lower quantities, that some of the pulses of the hormones GnRN, LH and FSH that are released by the pituitary gland are still maintained. This could again place Natesto® as a TRT of choice when compared to competing TRT drugs, which can cause complete suppression of the hypogonadal-pituitary-gonadal axis.
Natesto® Study Results Are "First Of Its Kind" Data
A primary contributor to the growing confidence for Natesto® becoming a TRT drug market leader is that the study results are generating first of its kind data, showing the potential that Natesto® may ultimately become the only TRT drug able to provide the benefits of testosterone replacement while at the same time preserving fertility. From a marketing perspective, if Natesto® becomes the only TRT drug that can make such a claim, the rewards can be substantial.
And, not only can such a claim generate a substantial increase in new prescription rate growth, it would broaden the market opportunity for Natesto® significantly. Most importantly, it could place Natesto® in the enviable position to target the approximately 20% of men with Low T (2 million men or more) that are still in their ‘family formation' years, but because of the known effects that competing TRT products can have on fertility, until now couldn't be treated with testosterone.
As noted, the final data release from the Spermatogenesis Study is expected in roughly three to four months (depending on publication schedules), which could provide AYTU with a significant catalyst to continue its run beyond its four-quarters of consecutive record-breaking revenue growth. Moreover, if the interim results are confirmed, Natesto® may be well-positioned to market exclusively toward the roughly two-million men that need the benefits of testosterone treatment but also want to maintain fertility. And, while that select market alone could be substantial, it is only a small segment of the $1.8 billion market population that Natesto® will be targeting.
Catalysts For AYTU Forthcoming?
Investors appear to be expecting good news, and the rally in the share price of more than 150% since the beginning of the year may prove that point. And, as Natesto® continues to generate additional data to support its best-in-class potential, the likelihood that it can become a "game changer" in the TRT industry is growing. Hence, the coming quarters may prove exciting for AYTU.
All told, with analysts covering AYTU stock offering 12-month price targets that range between $4.00 and $10.00, respectively, the interest in AYTU stock may just now be heating up.
Disclosure: Author is LONG Aytu BioScience stock and does not intend to either purchase or sell shares within 72 hours after publication of this article. For additional disclosures related to video production and news coverage for Aytu BioScience, please click here. This article also appeared on Soulstring Report.
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