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Tonix Pharmaceuticals Announces FDA Orphan-Drug Designation for TNX-2900 for the Treatment of Prader-Willi Syndrome

Tonix Pharmaceuticals Announces FDA Orphan-Drug Designation for TNX-2900 for the Treatment of Prader-Willi Syndrome

Tonix Prescribed drugs Keeping Corp.

CHATHAM, N.J., March 03, 2022 (Globe NEWSWIRE) — Tonix Prescribed drugs Keeping Corp. (Nasdaq: TNXP) (Tonix or the Corporation), a scientific-phase biopharmaceutical organization, these days introduced that the U.S. Foods and Drug Administration (Food and drug administration) has granted Orphan-Drug Designation for TNX-2900* (intranasal potentiated oxytocin) for the therapy of Prader-Willi syndrome.

“Orphan-Drug Designation by the Food and drug administration is an important milestone and even more validates our efforts to look into the utility of TNX-2900 for Prader-Willi syndrome,” claimed Seth Lederman, M.D., Chief Govt Officer of Tonix Prescription drugs. “It underscores the urgent, unmet healthcare need to have for individuals identified with this illness, and will benefit us as we continue to progress our application.”

As just lately introduced, Tonix entered into a sponsored investigate settlement with Inserm Transfert, the personal subsidiary of Inserm, on behalf of Inserm (the French Nationwide Institute of Wellness and Healthcare Research) and Aix-Marseille Université to examine oxytocin in the genetically engineered mouse product of Prader-Willi syndrome, a rare genetic condition that leads to unique, but associated pathological having conditions in grown ups and newborns. In older people, Prader-Willi causes hyperphagia, or pathological more than-feeding on, which leads to obesity and other troubles affiliated with substantial mortality. In newborns, Prader-Willi brings about a deficiency in suckling, which has been shown to be normalized by oxytocin procedure.

The FDA’s Office of Orphan Drug Items grants orphan status to the lively moiety of drugs and biologics that reveal promise for the procedure of ailments or conditions influencing much less than 200,000 individuals in the United States. Orphan drug designation offers Tonix Prescribed drugs with sure enhancement incentives, like tax credits for experienced clinical tests, exemptions from sure Food and drug administration application fees, and potential market exclusivity for seven years, if permitted.

*TNX-2900 is an investigational new drug and has not been authorised for any indication.

About Prader-Willi Syndrome

Prader-Willi syndrome is recognized as the most popular genetic induce of daily life-threatening childhood being overweight1 and impacts males and females with equal frequency and all races and ethnicities. The hallmarks of Prader-Willi syndrome are lack of suckling in infants and, in little ones and grown ups, severe hyperphagia, an overriding physiological push to take in, major to serious being overweight and other difficulties connected with significant mortality. There is at this time no approved treatment method for possibly the suckling deficit in toddlers or the obesity and hyperphagia in older children affiliated with Prader-Willi syndrome.

1Basis for Prader-Willi Analysis (fpwr.org).

About TNX-2900 and Tonix’s Potentiated Oxytocin System

TNX-2900 is dependent on Tonix’s patented intranasal potentiated oxytocin formulation meant for use by adults and adolescents. Tonix’s patented potentiated oxytocin formulation is believed to maximize specificity for oxytocin receptors relative to vasopressin receptors as perfectly as to enrich the efficiency of oxytocin. Tonix is also building a distinct intranasal formulation and gadget, specified TNX-1900, for prophylaxis of continual migraine and for the remedy of insulin resistance and relevant disorders. Oxytocin is a obviously transpiring human hormone that functions as a neurotransmitter in the mind. It was initially approved by the U.S. Meals and Drug Administration as Pitocin®*, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal variety of oxytocin was promoted in the U.S. by Novartis to assist in the output of breast milk as Syntocinon®** (oxytocin nasal 40 units/ml), but the products was discontinued, and the New Drug Software was withdrawn.

*Pitocin® is a trademark of Par Pharmaceutical, Inc.

**Syntocinon® is a trademark of BGP Products Operations GmbH.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a medical-stage biopharmaceutical corporation concentrated on getting, licensing, getting and developing therapeutics and diagnostics to handle and prevent human sickness and relieve struggling. Tonix’s portfolio is composed of immunology, infectious disease, and central nervous procedure (CNS) item candidates. Tonix’s immunology portfolio involves biologics to tackle organ transplant rejection, autoimmunity and most cancers, together with TNX-15001 which is a humanized monoclonal antibody focusing on CD40 ligand being created for the avoidance of allograft rejection treatment method of autoimmune conditions. A Stage 1 review of TNX-1500 is anticipated to be initiated in the next fifty percent of 2022. Tonix’s infectious disease pipeline consists of following-generation vaccines to avoid COVID-19, an antiviral to deal with COVID-19, and a prospective therapy for Extensive COVID. The pipeline also contains a vaccine in enhancement to stop smallpox. Tonix’s lead vaccine prospect for COVID-19, TNX-18002, is a stay virus vaccine centered on Tonix’s recombinant pox vaccine (RPV) system. TNX-35003 (sangivamycin, i.v. resolution) is a smaller molecule antiviral drug to deal with acute COVID-19 and is in the pre-IND phase of progress. TNX-102 SL4 , (cyclobenzaprine HCl sublingual tablets), is a little molecule drug getting created to deal with Very long COVID, a persistent write-up-COVID affliction. Tonix expects to initiate a Section 2 analyze in Lengthy COVID in the first 50 % of 2022. The Company’s CNS portfolio features each compact molecules and biologics to treat pain, neurologic, psychiatric and addiction problems. Tonix’s guide CNS applicant, TNX-102 SL, is in mid-Period 3 improvement for the administration of fibromyalgia with a new Phase 3 study anticipated to get started in the first half of 2022. Ultimately, TNX-13005 is a biologic created to handle cocaine intoxication that is expected to commence a Stage 2 trial in the to start with quarter of 2022.

1TNX-1500 is an investigational new biologic and has not been accredited for any sign.

2TNX-1800 is an investigational new biologic and has not been permitted for any indicator. TNX-1800 is based mostly on TNX-801, dwell horsepox virus vaccine for percutaneous administration, which is in growth to secure from smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been authorized for any indication.

3TNX-3500 is an investigational new drug at the pre-IND phase of growth and has not been accredited for any indicator.

4TNX-102 SL is an investigational new drug and has not been authorised for any indication.

5TNX-1300 is an investigational new biologic and has not been accepted for any indicator.

This press launch and even more info about Tonix can be observed at www.tonixpharma.com.

Forward-Looking Statements

Sure statements in this push launch are ahead-looking within just the indicating of the Private Securities Litigation Reform Act of 1995. These statements may possibly be determined by the use of ahead-searching words and phrases these types of as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” amongst many others. These ahead-on the lookout statements are based on Tonix’s latest expectations and true results could vary materially. There are a range of things that could bring about real occasions to differ materially from all those indicated by these types of ahead-on the lookout statements. These components incorporate, but are not limited to, dangers related to the advancement of TNX-2900, the failure to attain Fda clearances or approvals and noncompliance with Food and drug administration restrictions delays and uncertainties brought on by the international COVID-19 pandemic pitfalls related to the timing and development of clinical growth of our solution candidates our require for added financing uncertainties of patent security and litigation uncertainties of govt or 3rd social gathering payor reimbursement limited exploration and improvement attempts and dependence on third events and significant competition. As with any pharmaceutical below progress, there are major risks in the improvement, regulatory acceptance and commercialization of new merchandise. Tonix does not undertake an obligation to update or revise any ahead-seeking assertion. Buyers should study the possibility elements set forth in the Yearly Report on Type 10-K for the calendar year finished December 31, 2020, as filed with the Securities and Trade Fee (the “SEC”) on March 15, 2021, and periodic experiences submitted with the SEC on or just after the date thereof. All of Tonix’s forward-hunting statements are expressly competent by all these kinds of risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (company)
Tonix Prescribed drugs
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(212) 688-9421

Olipriya Das, Ph.D. (media)
Russo Associates
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(646) 942-5588

Peter Vozzo (traders)
ICR Westwicke
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(443) 213-0505