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Inhibitor Therapeutics Offers a Promising Pipeline and an Experienced Management Team

24 Jan Inhibitor Therapeutics Offers a Promising Pipeline and an Experienced Management Team

Inhibitor Therapeutics (OTCQB: INTI), a Biopharmaceutical Company focussed on addressing the unmet medical needs in the field of cancerous and non-cancerous proliferation disorders, announced the receipt of an Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for traconazole, intended for the treatment of Prostate Cancer. The Company is planning to initiate an IND opening clinical study as a two part multi-center, randomized, double-blind, placebo-controlled, Phase 2b clinical trial to evaluate the safety and efficacy of SUBA-Itraconazole capsules, in combination with docetaxel and prednisone in patients suffering from metastatic castrate resistant prostate cancer (mCRPC), as per a Company statement.

The PREDICT (Prostate Response Evaluating Docetaxel Itraconazole Combination Therapy) is likely to be carried out across 35 sites in six countries in North America, Western Europe and Eastern Europe. SUBA-Itraconazole is specifically being tested for its efficacy for the treatment of late-stage mCRPC that no longer responds well to androgen deprivation therapy (ADT), chemotherapy or newer age therapies such as stand-alone anti-androgen therapies such as abiraterone, enzalutamide or apalutamide, and have dropped out of treatment owing to toxicity or other issues.

Nicholas J. Virca, INHIBITOR’s President and CEO, stated

“Following a face-to-face End-of-Phase-2 meeting with FDA last October and our submission of an IND application thereafter, I am pleased to announce that we have received IND clearance for our PREDICT trial. FDA confirmed that we can follow the 505(b)(2) regulatory pathway and, assuming positive results demonstrating an improvement in radiographic progression-free survival (rPFS) as our primary endpoint, also indicated that the general design and planned analysis of our study would adequately address the objectives necessary to support an eventual New Drug Application (NDA) submission for this indication. FDA also indicated that the final analysis of the key secondary endpoint of overall survival (OS) can occur following submission of the NDA for approval in the United States.”

SUBA- Itraconazole is a patented formulation of Itraconazole, which is an FDA-approved prescription medication that has demonstrated the ability to suppress brain tumor growth in animal models, along with anti-cancer effects in basal cell carcinoma, lung and prostate cancers in human clinical trials. Itraconazole works by acting as an antagonist (blocker) of SMO (SMOOTHENED), a protein receptor of the Hedgehog pathway, and is being developed in a super bioavailability form by Mayne Pharma, under cGMP (current Good Manufacturing Practice) standards for INHIBITOR’s use in our clinical trials.

Inhibitor Therapeutics (OTCQB: INTI)

Market Cap: $13.98M; Current Share Price: 0.0614USDChart
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Prostate Cancer is the second leading cause of death in men in the U.S, with over 1 in 41 men likely to succumb to the disease. According to an estimate by the American Cancer Society there would be 174,650 new cases of prostate cancer and 31,620 deaths from prostate cancer in 2019.

The current treatment options for the disease, which primarily affects the prostate gland, is removal of the gland surgically (Radical prostatectomy), Brachy Therapy (Implanting Radioactive Seeds into the prostate) and Conformal Radiation therapy in combination with hormonal therapy. In addition Chemotherapy and Androgen Suppression Therapy are used in cases of advanced cases of prostate cancer. The stage and grade of the disease along with the state of the patient with respect to age, existing illnesses and certain genetic factors determine the course of treatment.

A report by Datamonitor Healthcare estimates that the Total prostate cancer drug market will reach $13.5bn in 2024, growing at a CAGR of 8.6% from $6.4bn in 2015. The introduction of novel therapeutics and treatment methodologies, a rise in geriatric population and increased awareness will drive the growth in the market. However prohibitive treatment costs, adverse side-effects that include infertility may act as a deterrent for growth.

Inhibitor Therapeutics lead candidate SUBATM-Itraconazole, is a patented oral formulation of the FDA-approved anti-fungal drug, itraconazole that has demonstrated antagonist activity against multiple tumor types. In addition to metastatic castrate-resistant prostate cancer (mCRPC) the Company is also developing the candidate for the treatment of late-stage non-squamous non-small cell lung cancer (NSCLC).

The Company holds exclusive U.S. licensee for SUBA-Itraconazole and since itraconazole’s already enjoys FDA approval (505(b) (2) pathway); its clinical pipeline is de-risked. INHIBITOR has already undergone a Phase 2b trial clinical trial testing in 38 patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS) and proven its bioavailability, safety and anti-tumor efficacy. The study also showed that SUBA-Itraconazole has a better toxicity safety profile when compared to other oncology drugs using similar approach to treating basal cell carcinoma (BCC) lesions.

Image Source: Company

In addition to the SUBA-Itraconazole clinical development programs in prostate and lung cancer, the Company will intends to extend its pipeline by acquiring/licensing additional compounds in the areas of oncology and those with large unmet needs. One of its programs involves testing itraconazole analogues as a potential treatment for poorly operable BCC tumors as an adjunct therapy to surgery, especially to reduce surgical disfigurement on the face and the neck. The Company initiated a clinical trial in September 2019 and has the rights to a worldwide option agreement from the University of Connecticut.

Image Source: Company

The Company intends to capitalize on the history of the safe use of itraconazole in humans for anti-fungal indications, and surpass the need for pre-clinical animal studies for toxicity and Phase 1 human trials to establish safety. Inhibitor intends to apply for an IND clearance for lung cancer along with Phase 2 clinical trial protocols for other target indications.

Inhibitor has entered into a licensing agreement with Mayne Pharma (OTCPINK: MAYNF) for the U.S rights for BCCNS, giving it full control of the program along with making the requisite investments to ensure that the treatment reaches patients in multiple markets worldwide. Mayne will pay inhibitor a 9% royalty on net sales of SUBA-Itraconazole, besides $5 million for the development of SUBA-Itraconazole in prostate cancer, lung cancer and certain proliferative disorders as per the Company.

In addition the Company has also tied up with PSI CRO, a privately-owned, full-service clinical research organization (CRO), to headline its “PREDICT” Study (Prostate Response Evaluating Docetaxel Itraconazole Combination Therapy), while using the Wienberg group, a ProPharma Group Company, for regulatory support for SUBA-Itraconazole.

Risk Assessment 

  • The Company has plans to extend its pipeline of candidates by filing for an IND application for Phase 2b study via 505(b) (2) pathway in NS NSCLC along with pursuing FDA Fast Track and/or Breakthrough Therapy Designation status. A diverse pipeline with multiple clinical candidates not only mitigates risk but also results in optimal utilization of resources.
  • Inhibitors estimates that its lead candidate Itraconazole, has the potential to reach peak sales of $300 million in BCCNS, $215 million in late-stage prostate cancer, $270 million in late-stage lung cancer and $600 million in BCC making it an extremely lucrative market opportunity for the Company. This offers a great opportunity for the Company to gain a strong foothold in the industry.
  • The Company has entered into strategic licensing and collaboration agreement with Mayne Pharma for the development of Itraconazole for BCCNS indication. The funding agreement will fetch Inhibitor royalty sales as well as $5 million* (non-dilutive funding) for clinical development of SUBA-Itraconazole in late-stage prostate and lung cancers. The funds can be utilized for further clinical development and advancement of its pipeline.
  • Inhibitor’s growth strategy is based on acquiring / licensing additional drug candidates, especially orphan indications with a large unmet need. The Company has tied up with university of Connecticut to assess next-generation Itraconazole analogues with lower toxicities and more potent anti-cancer properties as per a company statement.
  • The Company is being spearheaded by a very experienced and capable management team with proven expertise in human therapeutics and diagnostics. This will help steer the Company in the right direction and navigate development and regulatory hurdles.
  • Clinical Trials are fraught with risk. Any setback can not only have an impact on the development of the candidate in question, but also impact those in the pipeline.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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