This article was originally published on Microdose and appears here with permission.

PharmaTher is one of the best kept secrets in the psychedelic medicine industry. With multiple Phase 2 trials underway, a growing pipeline of drug development and delivery methods, and a strong working relationship with the FDA (they have already received Orphan Drug Designation from the FDA for one of their programs) – PharmaTher appears well-positioned to corner the ketamine segment of the market.

The stock has spent some time in the 5-bag territory (reaching over $1 before this summer’s pullback) and is receiving very bullish price targets from analysts (HC Wainwright gave them $5- see their PsyCap appearance here).

Based on this impressive pipeline, it probably makes sense to follow their developments closely. See below for a company update and projections for 2022.

Focused on becoming a leader in the development and commercialization of specialty prescription ketamine products

Milestones planned for 2022 include the initiation of a Phase 3 clinical study of ketamine for treating Parkinson’s disease (KETLID); completion of the Phase 2 clinical study of ketamine to treat ALS (KETALS); complete an observational study with ketamine and betaine for depression and pain (KETABET); launch of a phase 2 clinical study for the ketamine microneedle patch (KETAPATCH); and seeks FDA approval for Ketamine Hydrochloride Injection USP product (KETARX)

TORONTO, Dec. 21 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine prescription based products, is pleased to provide an update on the product pipeline and milestones expected for 2022.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said: “2021 has proven to be a fundamental year for PharmaTher, as we have achieved a number of milestones which set the stage for an exciting 2022 to unlock the therapeutic potential of ketamine in the treatment of Parkinson’s disease and ALS, the development of our ketamine hydrochloride injection product USP and our ketamine microneedle patch as a potential next-generation therapeutic solution for mental health, neurological and pain disorders. We are now in a position, both operationally and financially, to seek FDA approval for KETARX, our ketamine prescription product, and to enter clinical studies for KETAPATCH, our ketamine patch product, in 2022.”

KETLID project: Kitamine for Levodopa-Iinduced Dyskinesia in Parkinson’s disease

The company’s Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04912115) to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia (“LID”) in Parkinson’s disease patients is currently ongoing and the company now expects first results in Q1-2022. Positive Phase 2 clinical results will allow the Company to request a meeting with the FDA to discuss its plan and obtain approval to proceed to a Phase 3 clinical study under the company’s 505(b)2 regulatory pathway. here Q3-2022.

PharmaTher has an exclusive license agreement with the University of Arizona for intellectual property protecting the potential use of ketamine to treat movement disorders. The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of patients with Parkinson’s disease who received ketamine for pain relief. During this analysis, it was observed that patients experienced improvement in LID for several weeks beyond treatment. [Sherman et al, 2016]. These results were corroborated in a low-dose ketamine test in a rodent LID model, and this possible effect was also examined in a controlled study. [Bartlett et al, 2016].

KETALS project: Kitamine for Amyotroph Llateral Sclerosis (ALS or Lou Gehrig’s disease)

An investigator-initiated IND request has been submitted and it is expected that the FDA will accept the IND to proceed with a clinical study of ketamine to treat ALS patients within the next 30 days. Patient enrollment is planned for the first quarter of 2022. On August 3, 2021, the company was granted Orphan Drug Designation by the FDA for ketamine for the treatment of ALS.

PharmaTher has an exclusive license agreement with the University of Kansas for intellectual property protecting the potential use of ketamine to treat ALS. Ketamine has the potential to effectively increase the life expectancy of people with ALS at any stage and slow the progressive loss of muscle associated with poor disease outcomes. University of Kansas Medical Center researchers and inventors of the potential use of ketamine to treat ALS, Dr. Richard J. Barohn, MD, John A. Stanford, Ph.D., and Dr. Matthew Macaluso, DO, made the promising discovery that ketamine can be administered as an effective treatment for ALS. Additionally, unpublished and patent-pending preclinical research has shown that administration of ketamine preserves muscle function in the progression of ALS and increases life expectancy when administered in the early stages of muscle decline.

KETABET project: Ketamine and Betgroin combined formulation

The company is supporting an observational, researcher-led study to assess the impact of betaine anhydrous on adverse ketamine side effects seen after ketamine treatment in subjects with depression. The Company now expects the results to be released early in the first quarter of 2022. Based on the results, the Company will advance the KETABET program with its microneedle patch for clinical studies in H2-2022.

PharmaTher has an exclusive license agreement with the National Health Research Institutes for the development and commercialization of a patented combination formulation of ketamine and betaine approved by the FDA. KETABET has been shown in research to enhance antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine. The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and the combination blocked the psychotomimetic effects of ketamine [Lin, Jen-Cheng et al., 2016].

KETAPATCH project: Ketamine Microneedle Room

In collaboration with Queen’s University Belfast (“QUB”), led by Professor Ryan Donnelly, the company has successfully completed the evaluation of a patented hydrogel-forming micro-needle patch to deliver ketamine and KETABET as a potential next generation treatment for neuropsychiatric, neurodegenerative and pain disorders. This risk reduction step supports the company’s expansion in completing IND-enabling studies and scaling up clinical manufacturing with LTS Lohmann, a leader in transdermal delivery systems, to support regulatory submissions to the FDA and international. Validation and technology transfer activities to support clinical studies are ongoing and the Company plans to conduct clinical studies in H2-2022.

PharmaTher has an exclusive license agreement with QUB for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product development and clinical initiatives with the ketamine and psychedelics. Professor Donnelly’s lab has completed its research and published a paper titled “Hydrogel-Forming Microneedle Arrays as a Therapeutic Option for Transdermal Delivery of Esketamine” validating the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch that may overcome the disadvantages associated with administering ketamine as an intravenous or nasal spray [Courtenay, Aaron J et al., 2020].

KETARX project: Ketamy prescription (Rx) Product

The Company is developing its own Ketamine Hydrochloride Injection USP product as part of its plans to support the Company’s future Phase 3 clinical studies and commercialization plans in the United States via a Supplemental Abbreviated New Drug Application (” sANDA”) with the FDA for use in anesthesia and procedural sedation. The company plans to file its sANDA in the fourth quarter of 2022 for commercialization in the United States and in international markets thereafter.

PharmaTher has entered into an agreement with Alcami Corporation, a global pharmaceutical contract development and manufacturing organization with extensive experience in cGMP sterile fill-finish products and controlled substance handling, for the clinical and commercial manufacture of Project KETARX of the society. The Company plans to form partnerships with research laboratories, ketamine clinics and pharmaceutical companies that: are seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dosage forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications. Additionally, the company will enter the market with KETARX targeting the FDA-approved label of ketamine for procedural anesthesia and sedation.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB:PHRRF) (CSE:PHRM) is focused on the research, development and commercialization of specialty prescription ketamine products, including KETAPATCH, a ketamine microneedle patch for mental health, neurological disorders and pain, and KETARX, a ketamine hydrochloride injection product USP for anesthesia and procedural sedation. Learn more about PharmaTher.com, Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli

Chief executive officer

PharmaTher Holdings Ltd.

Tel: 1-888-846-3171

E-mail: [email protected]

Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its regulation services provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.