Hoth Therapeutics Reports Being Set To Begin Phase 2 Study On First-Of-Its-Kind Skin Toxicity Ointment For Cancer Patients

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As medical research continues to make headway in the race to treat cancer, some of the most effective therapies to date boast improved survival rates but often come with painful and even debilitating side effects. In some cases, side effects can become so severe that patients drop out of treatment, even though doing so could mean their cancer won’t be fully treated.

Among those painful side effects is skin toxicity induced by epidermal growth factor receptor (EGFR) inhibitors. The powerful therapy has become one of the best weapons against some of the most difficult-to-treat cancers, but painful rashes and other skin and scalp conditions make it difficult to complete a full course of treatment.

Hoth Therapeutics Inc. HOTH hopes to offer the first dedicated EGFR-induced skin toxicity treatment, in the form of a fast-acting topical treatment that could become a leader in a $57 million EGFR skin toxicity market that is expected to exceed $323 million by 2030.

A Critical Unmet Need for an EGFR Skin Toxicity Treatment?

EGFR inhibitors are used to treat non-small cell lung cancer, breast cancer, pancreatic cancer, colon cancer and other types of cancers where high levels of EGFRs are found. These growth receptors are responsible for cell growth and, therefore, cancer cell growth in the cancers where they’re found.

EGFR inhibitors have become a first-line therapy for slowing or stopping the growth of cancer cells. In patients with colorectal cancer, EGFR inhibitors reduced the risk of disease progression by 30% and increased the chance of tumor shrinkage by 15%. In patients with non-small cell lung cancer, this therapy significantly increased overall survival and progression-free survival. Similar results have been seen in treating other high EGFR cancers. 

Despite its impressive ability to slow and even reverse the growth of cancer cells, EGFR inhibitor therapy suffers from a high patient dropout rate. In clinical trials, 36% of patients who begin EGFR inhibitor treatments drop out before reaching the second phase of therapy. Among real-world patients (those treated with already-studied and approved drugs, not clinical research phase drug candidates), the dropout rate ranges from 10% to 62% worldwide. 

One of the key reasons for dropping out before finishing the full course of treatment is the adverse reaction many patients experience. While rarely fatal, EGFR inhibitors carry painful side effects, chief of which is skin toxicity. 

Depending on severity, skin toxicity can cause abnormally dry and scaly skin, painful rashes with acne-like sores and even skin fissures. The higher the doses, the higher the chances of experiencing these painful side effects — but higher doses are key to maximizing efficacy while minimizing the chances that the cancer develops a resistance to the drug. 

To date, there is no approved product on the market specifically for EGFR skin toxicity. But developing an effective treatment that could prevent or heal those painful side effects might help patients make it through the full course of therapy at the higher doses needed to achieve the best odds of survival.

Some investors in this space have been eyeing AnaptysBio Inc. ANAB as a strong competitor in that fast-growing market. The clinical-stage biotech began Phase 3 trials in 2020 for Imsidolimab, its drug candidate meant to treat generalized pustular psoriasis, acne vulgaris and hidradenitis suppurativa.

While the drug may have potential to treat some of the symptoms of EGFR-induced skin toxicity, it still wouldn’t be specifically for that purpose and, importantly, it’s being developed as an injection, which is generally more difficult for patients to administer themselves and may not provide the immediate relief that a soothing topical ointment could.

Hoth’s Topical Drug Candidate for EGFR-Induced Skin Toxicity

The topical treatment targets the substance P receptor, a neuropeptide that plays a key role in neurogenic inflammation in the lungs, gut, skin and other peripheral organs. By focusing on this inflammation-causing receptor, HT-001 is formulated to target the root cause of skin toxicities.

In an early 12-week animal study, HT-001 reduced erlotinib-induced skin toxicities by 71% compared to the control group. That included a reduction in skin rash and hair loss.

Phase 2a Clinical Trials To Begin in Early 2022

Last February, Hoth announced positive feedback from the Food and Drug Administration (FDA) during its pre-investigational new drug (IND) meeting. In a statement on the meeting, Hoth CEO Robb Knie said, “The positive feedback from the FDA is a significant milestone for Hoth in executing our clinical development program for HT-001 in treating cancer patients suffering from dermatological ailments during EGFR inhibitor treatment."

In April, Hoth finalized the formulation of HT-001 that would be used in the upcoming Phase 2a clinical trials. Set to begin early this year, the phase 2a study is expected to observe up to 130 cancer patients receiving EGFR inhibitor therapy. 

After skin toxicity symptoms appear, patients will be split into four groups. One group will receive a placebo and act as the control group while the other three will receive formulas ranging from 0.5% to 2% concentrations to measure the efficacy, safety and tolerability of HT-001 at different doses. 

Preliminary results from the study could be available as early as the first quarter of this year. If those results confirm the strong treatment potential seen in early trials, Hoth plans to pursue the FDA’s expedited programs for serious conditions. 

The agency already confirmed that EGFR-induced skin toxicity may meet the criteria for a serious condition so with positive Phase 2a results, Hoth could reportedly have a strong application for the expedited program, which could help fast track the drug candidate’s arrival to the market.

This post contains sponsored advertising content. This content is for informational purposes only and not intended to be investing advice.