HOTH stock rose more than 100% on January 4, 2022, after the company announced proof-of-concept in mice experiments of HT-ALZ.
Hoth Therapeutics Announces HT-ALZ Therapeutic Shows Positive Results – Reduce Amyloid β in Alzheimer’s Disease
On January 4, 2022, Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, announced proof-of-concept data generated using an Alzheimer’s disease mouse model, supporting the therapeutic potential of HT-ALZ. The research was conducted as part of the company’s Sponsored Research Agreement with Washington University in St. Louis. HT-ALZ is a therapeutic in development under the 505(b)(2) regulatory pathway for the treatment of dementia related to Alzheimer’s disease (AD).
AD is a neurodegenerative disease that is characterized by aggregates of amyloid β (Aβ) plaques and neurofibrillary tangles of Tau protein in the brain, which contribute to the clinical symptoms of the disease such as dementia. The initial experiments, conducted by Carla Yuede, PhD, Associate Professor of Psychiatry, and John Cirrito, PhD, Associate Professor of Neurology, at Washington University School of Medicine, focused on investigating the effect of orally administered HT-ALZ to reduce the concentration of Aβ in the brain interstitial fluid, using an established Alzheimer’s Disease mouse model (aged APP/PS1+/- mice). The initial data from these studies shows a significant decrease in Aβ in both male and female APP/PS1+/- mice after acute treatment with HT-ALZ, compared to placebo-treated animals and baseline Aβ levels, supporting that HT-ALZ has the potential to modify Aβ plaque formation in the brain and be developed as an AD therapeutic.
“The overall positive result from these studies is a first step but a big one in the development of HT-ALZ as an Alzheimer’s therapeutic,” said Stefanie Johns, Chief Scientific Officer of Hoth Therapeutics, Inc. “HT-ALZ is a unique therapeutic in the AD development space because it is eligible for streamlined development under the 505(b)(2) pathway, including available safety data. This allows Hoth to reach efficacy clinical trials faster and bring a new potential treatment for patients with Alzheimer’s disease.”
“The results of these experiments show a reduction in circulating brain Aβ in our model, and we are looking forward to determining how these changes influence behavior and cognitive function,” said Dr. Yuede.
Future research studies to be conducted by Dr. Cirrito and Dr. Yuede will investigate the effect of HT-ALZ on memory, anxiety, and executive function in the APP/PS1+/- mice model after chronic dosing with HT-ALZ.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. Hoth’s pipeline development is focused to improve the quality of life for patients suffering from indications including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell derived cancers and anaphylaxis and pneumonia. Hoth has also entered into two different agreements to further the development of two therapeutic prospects to prevent or treat COVID-19. To learn more, please visit https://ir.hoththerapeutics.com/
Hoth Therapeutics Announces Submission of Orphan Drug Designation Request for HT-KIT to Treat Mastocytosis
On December 21, 2021, Hoth Therapeutics, Inc. (NASDAQ: HOTH) a patient-focused clinical-stage biopharmaceutical company, announced it submitted an Orphan Drug Designation Request to the US Food and Drug Administration (FDA) for HT-KIT for the treatment of mastocytosis.
HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting, resulting in apoptosis of neoplastic mast cells. The KIT signaling pathway is implicated in multiple diseases, including all types of mastocytosis (such as aggressive systemic mastocytosis (ASM), mast cell leukemia (MCL), and systemic mastocytosis with associated hematological neoplasm (SM-AHN)), acute myeloid leukemia, gastrointestinal stromal tumors, and anaphylaxis.
Drugs intended to treat orphan diseases (rare diseases that affect less than 200,000 people in the US) are eligible to apply for Orphan Drug Designation (ODD), which provides multiple benefits to the sponsor during development and after approval. Hoth intends to pursue these benefits as part of the drug development for HT-KIT for treatment of mastocytosis, pending designation of the ODD Request.
Benefits of Orphan Drug Designation
Under the Orphan Drug Act, drug companies can apply for ODD, and if granted, the drug will have a status which gives companies exclusive marketing and development rights along with other benefits to recover the costs of researching and developing the drug. A tax credit of 50% of the qualified clinical drug testing costs awarded upon drug approval is also possible. Regulatory streamlining and provide special assistance to companies that develop drugs for rare patient populations. In addition to exclusive rights and cost benefits, the FDA will provide protocol assistance, potential decreased wait-time for drug approval, discounts on registration fees, and eligibility for market exclusivity after approval.
Key benefits of ODD:
- 7 years exclusivity post-approval
- Tax credits of 50% off the clinical drug testing cost awarded upon approval
- Waiver of new drug application (NDA)/ biologics license application (BLA) application fee
Hoth recently announced that its novel anti-cancer therapeutic exhibited highly positive results in humanized mast cell neoplasm models, representative in vitro and in vivo models for aggressive, mast cell-derived cancers such as mast cell leukemia and mast cell sarcoma.
📺 Hoth Therapeutics | Benzinga Healthcare Small Cap Conference[embedyt] https://www.youtube.com/watch?v=skR247ML-30[/embedyt]
📉 HOTH Stock Technical Analysis
The short term trend is negative, as is the long term trend. There should be more interesting stocks out there. HOTH is one of the lesser performing stocks in the Pharmaceuticals industry. 70% of 263 stocks in the same industry do better. HOTH is currently trading in the lower part of its 52 week range, which is not a good signal considering the S&P500 Index is trading near new highs.
There is support at 0.99 from a trend line in the weekly time frame. There is also a support zone ranging from 0.94 to 0.95. This zone is formed by a combination of multiple trend lines in multiple time frames.
The technical rating of HOTH is bad and it also does not present a quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first. Click here to sign up for email alerts on when HOTH stock consolidates and is a good entry.