Clarus Announces Initiation of Phase 4 Clinical Trial of JATENZO® (testosterone undecanoate) for the Treatment of Hypogonadal Men with Chronic Kidney Disease

JATENZO is the first and only FDA-approved oral softgel for testosterone (T) replacement therapy in adult males who have deficient T due to certain medical conditions

Clarus expects to announce results from the trial in the first half of 2023

NORTHBROOK, Ill., March 16, 2022 (GLOBE NEWSWIRE) -- Clarus Therapeutics Holdings, Inc. (Clarus) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today announced the initiation of screening for the first patient in an investigator-initiated Phase 4 clinical trial designed to evaluate the efficacy and safety of JATENZO (testosterone undecanoate) oral softgel capsules for the treatment of adult hypogonadal men with chronic kidney disease (CKD). Clarus expects to announce results from the trial in the first half of 2023.

“We are excited screening has begun for the first patient in this trial of hypogonadal men with CKD,” said Dr. Robert Dudley, President and Chief Executive Officer of Clarus. “Patients with CKD suffer from a myriad of comorbidities, which often include profound reductions in circulating T. Epidemiological data indicate that an estimated two million men with CKD are clinically hypogonadal and thus may benefit from T replacement therapy. This will be the first of several life cycle management studies for JATENZO designed to maximize the potential for treatment of specific patient populations where T deficiency is a component of their compromised health.”

“We know in men suffering from CKD that T levels decrease as kidney function decreases. These men may also have a decrease in hemoglobin levels (anemia) that need to be treated with often expensive medications, such as epoetin,” said Sandeep Dhindsa, M.D., Division Director of Endocrinology at Saint Louis University School of Medicine in St. Louis, Missouri, and primary investigator in this trial. “Because JATENZO increases T levels and has a positive impact on hemoglobin levels, our hypothesis is that JATENZO, with its flexible oral dosing options, could become an important treatment option for hypogonadal adult men with CKD. These men also may prefer JATENZO over other T treatment modalities because it is administered orally as a softgel capsule.”

About Clarus’ Phase 4 Clinical Trial for JATENZO in Patients with CKD 
This Phase 4 clinical trial (NCT05249634) is an investigator-initiated, single-center, single-arm study to investigate if adult men with Stage 3b or Stage 4 CKD and hypogonadism will show improvement when treated with JATENZO twice daily for 26 weeks. The primary endpoint is the achievement of T levels in the eugonadal (normal) range from baseline to after six months of treatment with JATENZO. Key secondary endpoints include measurement of hemoglobin, free T, lean mass, muscle strength, fat mass, sexual function assessment, quality of life, and key safety variables from baseline to after six months of treatment with JATENZO.

About Chronic Kidney Disease (CKD)
Chronic kidney disease is a condition where the kidney gradually loses function over time and can result in serious health problems and sometimes even death. An estimated 37 million adults in the United States have CKD, with diabetes and high blood pressure the leading causes of this condition. Over two million men with CKD also suffer from hypogonadism. Other health problems associated with CKD can include anemia, loss of muscle mass, and a decrease in quality of life.

About Male Hypogonadism
Male hypogonadism is a condition that results when the testes do not produce enough testosterone. Symptoms associated with male hypogonadism can include depression, decreased sex drive, decreased muscle mass, and decreased bone density, among others. An estimated 20 million men in the U.S. have hypogonadism, with approximately six million patients diagnosed. Treatments for male hypogonadism may include testosterone replacement therapy.

About Clarus Therapeutics Holdings, Inc.
Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus’ first commercial product is JATENZO® (testosterone undecanoate). For more information, visit www.clarustherapeutics.com and www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).

Clarus Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” for purposes of the federal securities laws. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Clarus’ forward-looking statements in this press release include, but are not limited to, statements regarding timing and results of the CKD Phase 4 trial, the benefits of T replacement therapy in certain populations, patients’ drug administration preferences, and its life cycle management programs for JATENZO, among others. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that Clarus has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Clarus’ control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with conducting clinical trials, other risks of pharmaceutical development, risks associated with Clarus’ financial position, and those factors described under the heading “Risk Factors” in the prospectus filed with the Securities and Exchange Commission (the SEC) under Rule 424(b)(3) on December 23, 2021, and those that are included in any of Clarus’ future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of Clarus’ assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that Clarus considers immaterial, or which are unknown. It is not possible to predict or identify all such risks. Clarus’ forward-looking statements only speak as of the date they are made, and Clarus does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

JATENZO® is a registered trademark of Clarus Therapeutics Holdings, Inc.

Clarus Contact:
Kara Stancell
Vice President, Investor Relations & Corporate Communications
kstancell@clarustherapeutics.com 
(847) 562-4300 x 206

About JATENZO

Indication
JATENZO^® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

• Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
• Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitation of use
Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

• JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
• Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
• Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
• Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

CONTRAINDICATIONS
JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

WARNINGS AND PRECAUTIONS

• Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently.
• Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
• Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management.
• Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
• Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO.
• Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated.
• Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
• Gynecomastia may develop and persist in patients being treated for hypogonadism.
• Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease.
• Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy.
• Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients.
• Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
• Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials.

ADVERSE EVENTS
The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at www.jatenzo.com. 

© 2022 Clarus Therapeutics, Inc. All rights reserved.